Medical Policy: 07.01.81 

Original Effective Date: December 2020 

Reviewed: December 2020 

Revised:  

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Laser interstitial thermal therapy (LITT) is a minimally invasive treatment using a focused beam of electromagnetic radiation emitted from a laser that is stereotactically placed into a targeted location. The laser then induces hyperthermia to ablate the target minimizing injury to the surrounding tissues while magnetic resonance imaging (MRI) thermography is used to monitor tissue temperatures. Thermal ablation purportedly leads to cellular apoptosis, necrosis, tissue coagulation or tumor cytoreduction.

 

Other terms for LITT include, but may not be limited to, focal laser therapy, interstitial laser ablation, interstitial laser coagulation, interstitial laser photocoagulation, laser induced thermal therapy, MRI-guided laser interstitial thermal therapy (MRgLITT) (e.g. Neuroablate, Visulase) and photothermal therapy.

 

The use of laser interstitial thermal therapy (LITT) is currently being researched to include but not limited to the following indications, brain tumors and breast tumors, prostate cancer, osteoid osteoma (bone tumor), lung cancer, liver cancer, radiation necrosis and epilepsy.

 

Brain Tumors

Laser Interstitial Thermal Therapy for the Treatment of Nonglioblastoma and Glioblastoma

Brain cancer is a clinical term that encompasses a wide variety of malignant tumors originating in brain tissue and its adnexa, as well as metastases from distant tumors. About 60% of the estimated 17,000 primary brain tumors diagnosed yearly are gliomas, which arise from the central nervous system’s non-neuron cells. Most gliomas are high-grade (World Health Organization grade II and I) and feature poorly differentiated cells, an aggressive course, and a poor prognosis. Patients typically survive 12 to 16 months after diagnosis. Low-grade tumors have well-differentiated cells and better prognosis, with patients surviving a median 10 years. Nongliomas vary greatly in origin and evolution; common tumors include meningiomas (benign tumors arising from the meninges), oligodendrogliomas (slow-growing neuronal tumors), and medulloblastomas (malignant tumors arising from immature neurons and occurring almost exclusively in children). Metastases from other sites account for about 60% of all intracranial tumors, and most have a poor prognosis typically associated with advanced cancers. Common origins include breast, bone, lung, urogenital, and skin cancers.

 

Many factors influence clinician and patient decisions regarding brain cancer treatment, including tumor type and prognosis, treatment goals (curative versus palliative), comorbidities, symptoms, and patient physiologic status and life expectancy. Treatment may consist of surgical resection with or without interstitial chemotherapy (i.e., Gliadel® nitrosourea wafers), external beam radiation therapy, brachytherapy, chemotherapy, and immunotherapy. Laser interstitial thermal therapy (LITT) is a minimally invasive tissue ablation technique that uses continuous or pulsed lasers to achieve thermal coagulation of tumor cells while minimizing damage to the surrounding tissues. Because laser energy is delivered with a fiberoptic catheter through a burr hole in the skull, LITT may constitute an alternative to conventional craniotomy, in particular for patients at high risk of surgical complications, with tumors in hard-to-reach brain areas, or undergoing palliative debulking and who wish to avoid surgery.

 

Based on an ECRI systematic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is inconclusive as a minimally invasive alternative to surgical resection and stereotactic radiosurgery. Only small, low-quality studies at high risk of bias are available, and their findings are unclear and inconclusive because studies included mixed patient groups with different types of brain cancer that have very different evolution and prognosis. Prospective, multicenter studies focusing on each etiology and comparing LITT with surgery and alternatives, such as stereotactic beam radiosurgery (e.g., GammaKnife®), are needed to address these evidence gaps.

 

Glioblastoma (GBM) is the most common and aggressive type of glioma (i.e., a tumor arising from the central nervous system’s non-neuron cells). Gliomas compose 60% of the estimated 17,000 primary brain tumors diagnosed yearly in the United States; GBM accounts for 55% of all gliomas. GBM may occur in individuals of any age but are rare in children and are more prevalent in people between 45 and 70 years of age. GBM is also more common in men than women (3:2 ratio) and in Caucasians. Other risk factors include exposure to radiation and a family history of brain tumors. Clinicians classify gliomas according to their cell of origin and histopathologic features, which correlate with prognosis. Low-grade tumors (World Health Organization [WHO] grade II and I) have well-differentiated cells and better prognosis, with patients surviving a median 10 years. HGGs are poorly differentiated (“anaplastic”) astrocytomas with WHO grade III or IV and have a dire prognosis. Patients with grade IV gliomas (i.e., GBM) typically live for 12 to 16 months; fewer than 5% live beyond 5 years.

 

GBM is often resistant to standard chemotherapy. At the time of diagnosis, patients typically undergo biopsy or debulking surgery to remove as much of the tumor as possible. Many factors influence clinician and patient decisions regarding surgical intervention. Adjuvant therapy may include radiation, chemotherapy, or both, possibly followed by maintenance therapy with temozolomide. Virtually all GBMs recur. Second-line options depend on prior treatments, the extent and location of recurrence, and the patient's condition. Options may include a second debulking surgery with or without interstitial chemotherapy (i.e., Gliadel® nitrosourea wafers), radiation therapy, and salvage chemotherapy. LITT is a minimally invasive tissue ablation technique that uses continuous or pulsed lasers to achieve thermal coagulation of tumor cells while minimizing damage to the surrounding tissues. Because laser energy is delivered with a fiberoptic catheter through a burr hole in the skull, LITT may constitute an alternative to conventional craniotomy, in particular for patients at high risk of surgical complications, patients with tumors in hard-to-reach brain areas, or patients undergoing palliative debulking and who wish to avoid surgery.

 

Based on an ECRI systematic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is inconclusive as a minimally invasive alternative to surgical resection or as alternative to stereotactic radiation therapy for the treatment of glioblastoma multiforme (GBM) and other high-grade gliomas (HGGs). The available evidence on LITT ablation of HGGs is limited to small case series at high risk of bias. Published meta-analyses suggest that LITT may work as well as surgery, but findings need validation in prospective, multicenter studies with parallel control groups. Studies that assess LITT in conjunction with, or as an alternative to, stereotactic radiation therapy are also needed to define LITT’s optimal place in the HGG treatment pathway.

 

Systematic Reviews

Author/YearPurpose of Systematic ReviewResources Searched and Inclusion CriteriaFindings Reported by AuthorsAuthors Conclusions
Banerjee et.al. (2015) The use of magnetic resonance-guided laser-induced thermal therapy (MR-LITT) as a minimally invasive method of treating intra-cranial pathology is a rapidly growing field. The use of MR-LITT in neurooncology has shown promising results; however, there has been no review to date of the current literature A review of the published literature regarding MR-LITT in neurooncology was performed. Studies on PubMed were included if at least one patient with a cerebral tumour or radiation necrosis was treated using quantitative MR thermography-guided LITT, as well as if either safety or outcomes were discussed In treating recurrent Grade-III and IV gliomas, we found improved median overall survival of 20.9 months from diagnosis of recurrence, which is comparable with that of 18.9 months for high-dose-rate brachytherapy and 24.4 months for repeated open surgery. Median progression-free survival (PFS) of recurrent glioma is noted to be 4.5 months. For metastatic lesions, we found a median overall survival (OS) to vary between 9.0 and 19.8 months with a PFS between 3.8 and 8.5 months. Current literature reports median OS in similar patients to lie between 7.0 and 28.6 months. Severe complication rates (with permanent deficits) are found to be between 12 and 16.7%, comparable with 11% found in literature for open surgery The current literature shows that MR-LITT is safe and shows promising local tumour control rates. Larger randomised studies are warranted to further investigate this adjuvant therapy in the treatment of recurrent high-grade gliomas and metastases
Barnett et. al. (2016) To identify studies which examined extent of resection (EOR) or extent of ablation (EOA) and major complications (defined as neurocognitive or functional complications which last >3 months duration after surgery) associated with either brain laser interstitial thermal therapy (LITT) or open craniotomy in high-grade tumors in or near areas of eloquence A systematic review and meta-analysis was undertaken of the peer-reviewed literature Eight studies on brain LITT (n = 79 patients) and 12 craniotomy studies (n = 1,036 patients) were identified which examined either/both EOR/EOA and complications. Meta-analysis demonstrated an EOA/EOR of 85.4 ± 10.6% with brain LITT versus 77.0 ± 40% with craniotomy (mean difference: 8%; 95% CI: 2-15; p = 0.01; inverse variance, random effects model). Meta-analysis of proportions of major complications for each individual therapy demonstrated major complications of 5.7% (95% CI: 1.8-11.6) and 13.8% (95% CI: 10.3-17.9) for LITT and craniotomy, respectively In patients presenting with high-grade gliomas in or near areas of eloquence, early results demonstrate that brain LITT may be a viable surgical alternative
Ivan et. al. (2016) Investigate initial data on the use of magnetic resonance-guided laser-interstitial thermotherapy (MR-LITT) in the treatment of newly diagnosed high-grade gliomas The use of the PubMed, OVID, and Google-scholar database systems, a comprehensive search of the literature was performed and eighty-five articles were identified plus 1 that is pending publication. Four articles were accounted for in this review, including 25 patients with newly diagnosed high-grade gliomas who underwent MR-LITT treatment. We evaluated safety, progression-free survival, and overall survival Twenty-five patients with a mean age of 53.8 years underwent LITT treatments. On average, 82.9% of the pretreatment lesion volume was ablated. The average tumor volume treated was 16.5 cm. The mean follow-up time was 7.6 months. Median overall survival was found to be 14.2 months (range 0.1-23 months). The median progression-free survival was 5.1 months (range 2.4-23 months); however, these data are limited by the relatively short follow-up of the patients reviewed and small sample size of only 25 patients. There was 1 (3.4%) major perioperative complication, which was a central nervous system infection MR-LITT is a promising technology for the treatment of small, yet difficult-to-treat newly diagnosed high-grade gliomas. This study demonstrates that MR-LITT is safe, and future randomized studies are needed to evaluate its role as a treatment adjunct for newly diagnosed high-grade gliomas

 

Clinical Trials

Author/YearStudy Type and PatientsInterventionFindings Reported by AuthorsAuthors Conclusions
Authors were paid consultants for the manufacturer (Monteris) Retrospective, single-center case series of 80 patients with lesions located near corticospinal tracts (CSTs), including high-grade gliomas (n = 46), low-grade gliomas (n = 16), other tumors (n = 14), and radiation necrosis (n = 4) Stereotactic laser interstitial thermal therapy (LITT) guided by real-time MRI using NeuroBlate High-grade glioma (n = 46) was the most common indication for LITT. Postoperative motor deficits (PMDs) (partial or complete) were seen in 14 patients (11 with permanent and 3 with temporary PMDs). The median overlap volumes between CSTs with yellow, blue, and white thermal -damage-threshold (TDT) lines in patients with any PMD (temporary or permanent) were 1.15, 0.68, and 0.41 cm3, respectively. The overlap volumes and surface areas revealed significant differences in those with PMDs and those with no deficits (p = 0.0019 and 0.003, 0.012 and 0.0012, and 0.001 and 0.005 for the yellow, blue, and white TDT lines, respectively). The receiver operating characteristic was used to select the optimal cutoff point of the overlapped volumes and areas. Cutoff points for overlap volumes and areas based on optimal sensitivity (92%-100%) and specificity (80%-90%) were 0.103, 0.068, and 0.046 cm3 and 0.15, 0.07, and 0.11 mm2 for the yellow, blue, and white TDT lines, respectively Even a minimal overlap between the TDT lines and CSTs can cause a PMD after LITT. Precise planning and avoidance of critical structures and important white matter fibers should be considered when treating deep-seated tumors
Patel et. al. (2016)
Authors were paid consultants for the manufacturer (Monteris)
Retrospective, single-center case series of 102 patients with gliomas (n = 45), metastasis or radionecrosis (n = 37), epilepsy (n = 10), or chronic pain (n = 5) Real-time MRI-guided stereotactic laser interstitial thermal therapy (LITT) with the Visualase system A total of 133 lasers were placed in 102 patients who required intervention for intracranial tumors (87 patients), chronic pain syndrome (cingulotomy, 5 patients), or epilepsy (10 patients). The procedure was completed in 98% (100) of these patients. Ninety-two patients (90.2%) had undergone previous treatment for their intracranial tumors. The average (± SD) total procedural time was 170.5 ± 34.4 minutes, and the mean laser-on time was 8.7 ± 6.8 minutes. The average intensive care unit (ICU) and hospital stays were 1.8 and 3.6 days, respectively, and the median length of stay for both the ICU and the hospital was 1 day. By postoperative Day 1, 54% of the patients (n = 55) were neurologically stable for discharge. There were 27 cases of morbidity, including new-onset neurological deficits, and 2 perioperative deaths. Fourteen patients (13.7%) developed new deficits after the MRgLITT procedure, and of those 14 patients, 64.3% (n = 9) had complete resolution of deficits within 1 month, 7.1% (n = 1) had partial resolution of symptoms within 1 month, 14.3% (n = 2) had not had resolution of symptoms at the most recent follow-up, and 14.3% (n = 2) died without resolution of symptoms. The 30-day readmission rate was 5.6% MRgLITT, although minimally invasive, must be used with caution. Thermal damage to critical and eloquent structures can occur despite MRI guidance. Once the learning curve is overcome, the overall procedural complication rate is low, and most patients can be discharged within 24 hours, with a relatively low readmission rate. In cases in which they occurred, most neurological deficits were temporary. The therapeutic role of MRgLITT in various intracranial diseases will require larger and more rigorous studies
Kamath et. al. (2017)
Authors were paid consultants for the manufacturer (Medtronic)
Retrospective, single-center case series of 133 patients with intracranial lesions, including glioblastoma multiforme (GBM) (n = 57), other high-grade gliomas (n = 14), low-grade gliomas (n = 20), non-glioma tumors (n = 26), encephalocoele (n = 1), epileptic foci (n = 11), and radiation necrosis (n = 6) Stereotactic laser interstitial thermal therapy (LITT) guided by real-time magnetic resonance imaging (MRI), using the NeuroBlate LITT system A total of 133 intracranial lesions in 120 patients were treated with ILA, including glioblastomas (GBM), other gliomas, metastases, epilepsy foci, and radionecrosis. The rate of complications/unexpected readmission was 6.0%, and the mortality rate was 2.2%. With high-grade tumors, tumor volumes >3 cm in diameter trended toward a higher rate of complication (p = 0.056). Median progression-free survival (PFS) and overall survival (OS) for recurrent GBM were 7.4 and 11.6 months, respectively. As a frontline treatment for newly diagnosed GBM, median PFS and OS were 5.9 and 11.4 months, respectively. For metastases, median PFS was not yet reached, and OS was 17.2 months Our series suggests that ILA is a safe and efficacious treatment for a variety of intracranial pathologies, can be tailored to treat difficult-to-access lesions, and may offer a novel alternative to open craniotomy in properly selected patients

 

Systematic Review and Evidence -Based Guideline by the Congress of Neurological Surgeons

In 2019, the Congress of Neurological Surgeons completed a systematic review and evidence-based guideline on the role of emerging and investigational therapies for the treatment of adults with metastatic brain tumors. Brain metastases associated with systemic cancer remain challenging to treat. Current standard treatment modalities, including surgery and radiation, cannot be applied to all patients and are not uniformaly successful when applied. Therefore, novel treatment strategies are necessary. The objective of this paper is to review the available clinical research regarding non-standard or "emerging" therapies (high intensity focus ultrasound [HIFU], laser interstitial thermal therapy (LITT), radiation sensitizers, local therapy [radiation (intraoperative) or chemotherapy (carmustine wafer)], immune modulators [ipilimumab, nivolumab, vaccine], molecular targeted agents. Therapies considered "emerging" are in the investigational stage and generally are not currently in use aside from clinical trials. Electronic databases including MEDLINE and Cochrane were searched from September 2008 (the end date of previous search) through December 2015. Overall, 74 new studies met eligibility criteria.

 

Laser Interstitial Thermal Therapy (LITT)

Study Selection and Characteristics

Among 5 manuscripts screened met the criteria for inclusion in the guidelines. All studies were case series without control patients in a small number of patients. The largest study described 15 patients who received laser interstitial thermal therapy (LITT) for previously treated brain metastases (BMs) with post-radiosurgery progression or radiation necrosis.5 Laser interstitial thermal therapy is a minimally invasive surgical procedure in which a laser applicator is placed stereotactically and used to perform thermal ablation under magnetic resonance imaging (MRI) guidance. The other 3 studies described <10 patients each.

 

Results of Individual Studies

Each study demonstrated limitations inherent in small case series without a control population. Three studies used prospective data collection. In each study, LITT was demonstrated to be safe and well-tolerated. Efficacy was assessed using MRI to evaluate for local control and analysis of overall survival. Three of the studies addressed brain metastases only, while 1 included patients with other pathologies, such as glioma.3 In the largest case series, 15 patients were followed prospectively after receiving LITT for progressive BM or radiation necrosis after prior radiation treatment for BM. At a median 24 -weeks follow-up, 13 of 15 patients demonstrated local control, and the median PFS was 37 weeks.5 The remaining 3 manuscripts described 18 patients total with BM treated with LITT. Another prospective trial evaluated 17 patients, 5 of whom had progressive BM after prior radiation. The median PFS among these 5 patients was 5.8 months.3 The third prospective study was a pilot trial in which 7 patients with 15 BM refractory to chemotherapy and radiation were treated with LITT. In this study, local control was noted for all treated lesions at up to 30 months of follow-up, and median OS was 19.8 months

 

Synthesis of Results

In multiple small case series, LITT appears to be a safe treatment option for patients with BM. For patients with progressive disease after prior radiation, LITT may have value as a treatment option. In each study reviewed, the authors acknowledged the emerging nature of LITT as a treatment option for BM and suggested that larger clinical studies were necessary to determine its efficacy.

 

There is insufficient evidence to make a recommendation regarding the routine use of laser interstitial Thermal therapy (LITT), aside from use as part of approved clinical trials.

 

Summary of Evidence

Evidence from available studies suggests that laser interstitial thermal therapy (LITT) may be safe for brain neoplasms, but the studies are too limited in quality and scope to assess LITT’s effectiveness. Findings are at high risk of bias because studies individually reviewed are all small, often retrospective, and of single-center case series with no control groups. None of these studies reported on how LITT may improve symptoms, physical function, or quality of life. Some of the studies reported on patient survival, but these data compounded patients with very different etiologies and prognosis and may thus not generalize to any particular patient group. Furthermore, no studies provide data to assess LITT’s potential benefits over the current standard of care of surgical resection or over alternatives, such as stereotactic beam radiosurgery (e.g., GammaKnife). Prospective, multicenter studies that focus on specific etiologies and that include relevant control groups are needed to address these large evidence gaps. In 2019, the Congress of Neurological Surgeons issued a systematic review and evidence-based guideline on the role of emerging and investigational therapies for the treatment of adults with metastatic brain tumors that included the following recommendation: “Laser Interstitial Thermal Therapy, there is insufficient evidence to make a recommendation regarding the routine use of laser interstitial thermal therapy (LITT), aside from use as part of approved clinical trials." A review of the current NCCN guideline Central Nervous System Cancers Version 3.2020 the guideline does not address laser thermal therapy or laser ablation as a treatment in CNS cancers. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Meta-analysis of data from small case series supports laser interstitial thermal therapy (LITT’s) safety as a treatment for new or recurring high- grade gliomas (HGG) resection and suggests effectiveness similar to that of surgical resection. Nonetheless, the risks of bias remain high because of the small size of the overall patient sample and the inherent heterogeneity of small, single-center studies. Prospective, multicenter studies with parallel control groups are needed to validate available data. In addition, studies that assess LITT as an adjunct or alternative to stereotactic external beam radiation therapy are also needed to define LITT’s optimal place in the HGG treatment pathway. Because of HGG’s poor prognosis and high morbidity, assessment of quality of life and physical function is needed to evaluate LITT’s benefits. Thus, additional studies of LITT are warranted to define LITTs optimal place in the HGG treatment pathway. In 2019, the Congress of Neurological Surgeons issued a systematic review and evidence-based guideline on the role of emerging and investigational therapies for the treatment of adults with metastatic brain tumors that included the following recommendation: "Laser Interstitial Thermal Therapy, there is insufficient evidence to make a recommendation regarding the routine use of laser interstitial thermal therapy (LITT), aside from use as part of approved clinical trials."  A review of the current NCCN guideline Central Nervous System Cancers Version 3.2020 the guideline does not address laser thermal therapy or laser ablation as a treatment in CNS cancers. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Laser Interstitial Thermal Therapy for the Treatment of Lung Cancer

Metastatic lung cancer is a malignancy that originates from a primary tumor in a different part of the body and has spread to the lung. Lung metastases are identified in up to 55% of all patients with cancer, and their prevalence varies depending on the primary cancer type. Lungs are the second most common site for all metastases. Primary tumors that most commonly spread to the lungs include those in the bladder, thyroid, head and neck, colon, breast, prostate, connective tissue, kidney, and adrenal gland. Patients are typically asymptomatic but may also experience cough, shortness of breath, frequent chest infections, coughing up blood, pain or discomfort in the chest, and weight loss. Diagnosis includes blood tests to assess lung function; serum screening for cancer-specific genetic markers; chest radiography or advanced imaging techniques, such as computed tomography (CT) and positron emission tomography to visualize tumors; bronchoscopy; and transthoracic/transbronchial needle aspiration biopsy.

 

The goal of treating lung metastases is to control or slow tumor growth and spread. The main treatment for lung metastases is chemotherapy; oncologists typically recommend surgery (metastasectomy) only if a significant likelihood exists that it will be curative. Alternative methods for removing lung metastases include bronchoscopic or thoracoscopic interventions, such as electrocauterization, argon plasma coagulation, cryotherapy, brachytherapy, rigid bronchoscopy, endoluminal stent placement, RFA, and external beam radiotherapy. Laser interstitial thermal therapy (LITT) is a minimally invasive ablation technique used to treat multiple tumor types. LITT is intended as an alternative to surgical resection and energy-based ablation techniques, such as microwave ablation (MWA) or radiofrequency ablation (RFA).

 

Based on an ECRI systematic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is inconclusive as a minimally invasive alternative treatment for the treatment of lung metastases. Only low-quality, small, nonrandomized studies and case series address LITT for lung metastases. Findings are at high risk of bias and are of unclear significance because some studies pooled patients with different etiologies and prognoses. Randomized controlled trials focusing on each primary tumor type are needed to compare LITT with alternative treatments.

 

Clinical Trials

Nonrandomized Comparative Studies

Author/YearStudy Type and PatientsInterventionFindings Reported by Authors
Nour -Eldin et. al. (2017) Retrospective analysis comparing local tumor control, time to progression and survival rates in patients with pulmonary metastases from non-colorectal cancer origin; 109 patients (43 males and 66 females) Microwave ablation (MWA), radiofrequency ablation (RFA) and laser-induced thermotherapy (LITT) The overall- survival rates at 1, 2, 3 and 4 years were 93.8, 56.3, 50.0 and 31.3% for patients treated with LITT; 81.5, 50.0, 45.5, and 24.2% for patients treated with RFA and 97.6, 79.9, 62.3 and 45.4% for patients treated with MWA respectively. The man survival time was 34.14 months for MWA, 34.79 months for RFA and 35.32 months for LITT. In paired comparison a significant difference could be detected between MWA versus RFA (p=0.032. The progression free survival showed a median of 23.49 +0.62 months for MWA, 19.88 + 2.17 months for LITT and 16.66 + 0.66 months for RFA (p=0.048). The lowest recurrence rate was detected in lesions ablated with MWA (7.7%; 8 of 104 lesions) followed by RFA (20.4%; 10 of 49 lesions) and LITT (27.3%; 6 of 22 lesions) (p=0.012). Pneumothorax was detected in 22.16% of MWA ablations, 22.73% of LITT ablations and 14.23% of RFA ablations
Vogl et. al. (2016) Retrospective evaluation of local tumor control, time to tumor progression, and survival rates among patients with lung metastatic colorectal cancer; 109 patients (71 men and 38 women) Ablation performed using laser-induced thermotherapy (LITT), radiofrequency ablation (RFA) or microwave ablation (MWA) Local tumor control was achieved in 17 of 25 lesions (68.0%) treated with LITT, 45 of 65 lesions (69.2%) treated with RFA, and 91 of 103 lesions (88.3%) treated with MWA. Statistically significant differences were noted when MWA was compared with LITT at 18 months after ablation (p = 0.01) and when MWA was compared with RFA at 6 months (p = 0.004) and 18 months (p = 0.01) after ablation. The overall median time to local tumor progression was 7.6 months. The median time to local tumor progression was 10.4 months for lesions treated with LITT, 7.2 months for lesions treated with RFA, and 7.5 months for lesions treated with MWA, with no statistically significant difference noted. New pulmonary metastases developed in 47.6% of patients treated with LITT, in 51.2% of patients treated with RFA, and in 53.2% of patients treated with MWA. According to the Kaplan-Meier test, median survival was 22.1 months for patients who underwent LITT, 24.2 months for those receiving RFA, and 32.8 months for those who underwent MWA. The overall survival rate at 1, 2, and 4 years was 95.2%, 47.6%, and 23.8%, respectively, for patients treated with LITT; 76.9%, 50.8%, and 8.0%, respectively, for patients treated with RFA; and 82.7%, 67.5%, and 16.6%, respectively, for patients treated with MWA. The log-rank test revealed no statistically significant difference among LITT, RFA, and MWA. The progression-free survival rate at 1, 2, 3, and 4 years was 96.8%, 52.7%, 24.0%, and 19.1%, respectively, for patients who underwent LITT; 77.3%, 50.2%, 30.8%, and 16.4%, respectively, for patients who underwent RFA; and 54.6%, 29.1%, 10.0%, and 1.0%, respectively, for patients who underwent MWA, with no statistically significant difference noted among the three ablation methods

 

Summary of Evidence

Evidence from available studies suggests laser interstitial thermal therapy (LITT) may be safe for lung metastases, but the studies are too limited in size, quality, and scope to support conclusions. Comparative studies are at risk of bias due to lack of randomization. No studies reported on how LITT may improve symptoms (e.g., pain, difficulty breathing) or quality of life. The studies provide data on patient survival but included patient groups with different tumor etiologies. Because tumor origin is a critical factor in metastatic disease prognosis, the studies do not validate each other and may not generalize to other types of metastatic disease. Furthermore, no studies provide data to assess LITT as an alternative to surgical intervention or chemotherapy. Randomized controlled trials focusing on each primary tumor type are needed to compare LITT with alternative treatments. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Laser Interstitial Thermal Therapy for the Treatment of Liver Cancer

Metastatic liver cancer is a cancer that originated in a different part of the body and has spread to the liver. More common than primary liver cancer (cancer that originated in the liver), liver metastases often originate from colorectal, lung, breast, pancreatic, stomach, melanoma, and neuroendocrine tumors. Patients may remain asymptomatic or develop symptoms depending on the number and location of the tumors in the liver. Symptoms may include fatigue, loss of appetite, weight loss, fever jaundice, itchy skin, discomfort and swelling of the abdomen, and swelling of the ankles. Diagnosis includes the use of blood tests to assess liver function and MRI or CT imaging to visualize the tumors.

 

The goal of treating liver metastases is to control or slow tumor growth and spread. Complete removal of metastases typically requires surgery. The main treatment for liver metastases is chemotherapy; oncologists typically recommend surgery (liver resection) only if one or few tumors are found. In many cases, surgery is not possible because of the location of the tumors or the patient’s surgical risk. Alternative methods for removing liver metastases include ablative techniques, such as radiofrequency ablation, microwave ablation, ethanol ablation, cryosurgery, and arterial embolization. Laser interstitial thermal therapy (LITT) is a minimally invasive thermal ablation technique used to treat multiple tumor types. In patients with metastatic liver tumors, LITT is intended as an alternative to surgical resection or radiofrequency needle ablation and as adjunct to transarterial chemoembolization (TACE).

 

Based on an ECRI systemic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is inconclusive as a minimally invasive alternative treatment for the treatment of liver metastases. Only low-quality nonrandomized studies address LITT for liver metastases. Findings are at high risk of bias and are of unclear significance because some studies involved patients with different etiologies and prognoses. Randomized controlled trials focusing on each tumor type are needed to compare LITT with other methods (e.g., surgery, microwave, radiofrequency).

 

Clinical Trials

Nonrandomized Comparative Studies

Author/YearStudy Type and PatientsInterventionFindings Reported by AuthorsAuthors Conclusions
Vogel et.al. (2014) 110 patients with unresectable non-colorectal non-breast cancer liver metastases with progression under systemic chemotherapy. Excluded were patients with Karnofsky score ≤ 70, respiratory, renal and cardiovascular failure, and general TACE contraindications. Evaluate safety, feasibility and overall survival rates for transarterial chemoembolization (TACE) alone or combined with MR-guided laser-induced-thermotherapy (LITT) in liver metastases of non-colorectal and non-breast cancer origin

TACE using Mitomycin alone, Mitomycin-Gemcitabine or Mitomycin-Gemcitabine-Cisplatin was performed to all patients. After TACE 146 metastases were ablated with MR-guided LITT. To be eligible for LITT metastases should be < 5 cm in size and ≤ 5 in number. Tumor response was evaluated using MRI according to RECIST. Survival was evaluated using Kaplan-Meier analysis.

 

A total of 110 patients (mean age 59.2 years) with 371 metastases received TACE (mean 5.4 sessions/patient, n=110) with 76 (69%) receiving LITT (mean 1.6 session/patient) afterwards. TACE resulted in a mean decrease of mean maximum diameter of 52% ± 26.6 and volume change of -68.5% ± 22.9 in the 25 patients (23%) with partial response. Stable disease (n=59, 54%). Progressive disease (n=26, 23%). The RECIST outcome after LITT showed complete response (n=13, 17%), partial response (n=1, 1%), stable situation (n=41, 54%) and progressive disease (n=21, 28%). The mean time to progression (TTP) was 8.6 months. Median survival of all patients was 21.1 months.

TACE with different protocols alone and in combination with LITT is a feasible palliative treatment option resulting in a median survival of 21.1 months for unresectable liver metastases of non-colorectal and non-breast cancer origin
Linchun et. al. (2016) Eighty-five cases colorectal cancer liver metastases were assigned to the treatment group (43 cases) and to the control group (42 cases). The treatment group patients received LTA combined with FOLFIRI regimen chemotherapy, and the control group patients only received FOLFIRI regimen chemotherapy. The curative effects, the survival rate and adverse reaction of the two groups were observed and evaluated Study to evaluate the efficacy and adverse reaction of a combination therapy of chemotherapy and laser thermal ablation (LTA) on liver metastases from colorectal cancer Response rate was 53.4% in the treatment group and 38.1% in the control group (P>0.05); disease control rate in the treatment group was 79.1%, higher than 64.3% in control group with significant difference (P<0.01); median progression free survival was 11.8 months in treatment group and 6.8 months in control group (P<0.01); The median overall survival time was 19.1 months in treatment group and 14.9 months in control group (P<0.05). Among the 113 lesions receiving LTA, 104 lesions (92%) were completely destroyed. The main complications of LTA were fever and local pain. The adverse effects between both groups showed no difference LTA in combination with chemotherapy of colorectal carcinoma liver metastases is effective and well-tolerated

 

Case Series

Author/YearStudy Type and PatientsInterventionFindings Reported by AuthorsAuthors Conclusions
Pacella et. al. (2016) Ten patients (mean age: 53.6 years ± 14.1; range: 24–79) with neuroendocrine tumors (NETs) and 13 liver matastases (mean diameter: 4.3 ± 2.8 cm; range: 1.5–12) underwent LA alone (n = 9) or LA followed by selective transarterial chemoembolization (n = 3) Evaluate the effectiveness of laser ablation (LA) with or without selective transarterial chemoembolization in patients with large, isolated or oligonodular unresectable neuroendocrine liver matastases Complete response was obtained in six patients with LA alone and in two patients with combined treatment. The 5-year overall survival rates from the initial diagnosis and post-treatment were 80 and 50%, respectively This treatment modality may provide effective control of tumor burden and general symptoms improvement in patients with limited but unresectable disease

 

Summary Of Evidence

Evidence from available studies suggests that laser interstitial thermal therapy (LITT) may be safe for liver metastases, but the studies are too limited in quality and scope to support conclusions. Comparative studies are at risk of bias due to retrospective design and lack of randomization. Case series are at risk of bias due to single-center focus and lack of control groups. None of these studies reported on how LITT may improve symptoms (e.g., jaundice or pain from biliary obstruction) or quality of life. The studies provide data on patient survival but included patient groups with different tumor etiologies. Because tumor origin is a critical factor in metastatic disease prognosis, the studies do not validate each other and may not generalize to other types of metastatic disease. Furthermore, no studies provide data to assess LITT as an alternative to surgical resection or other ablative techniques. Prospective, multicenter studies that focus on specific etiologies and that include relevant control groups are needed to address these large evidence gaps. A review of the current NCCN guideline for Hepatobiliary Cancers Version 5.2020 does not address laser thermal therapy or laser ablation as treatment in hepatobiliary cancers. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Laser Interstitial Thermal Therapy for the Treatment of Prostate Cancer

Prostate cancer is the most common noncutaneous cancer affecting men. Prostate cancer often develops when the rate of cell division and cell death is no longer equal in the prostate tissue, leading to uncontrolled tumor growth. The majority of prostate cancers (95%) are adenocarcinomas, while 4% are transitional cell carcinomas arising from the urothelial lining of the prostatic urethra. Less common cases of prostate cancer (1%) are squamous cell carcinomas that typically arise after radiation or hormone treatment. In the United States, prostate cancer affects an estimated one in six Caucasian men and one in five African-American men, with the likelihood of developing the cancer increasing with age. Globally, the rate of prostate cancer is highest in men of sub-Saharan African ancestry and lowest in those of Asian ancestry. Other factors associated with the development of prostate cancer include familial predisposition, diet, hormones, genetics, and environmental factors.

 

Patients with prostate cancer may present with symptoms that include urinary retention, hematuria (blood in urine), or back pain, although the presence of symptoms more often indicates other underlying disease. Patients with advanced stages of prostate cancer will often present with skeletal manifestations due to the cancer’s tendency to metastasize to the bone. A physician is more likely to diagnose the disease in asymptomatic patients during a routine cancer screening, such as a prostate-specific antigen (PSA) level screening or digital rectal examination (DRE). A urologist may also diagnose prostate cancer incidentally while treating a patient for benign prostate hyperplasia (prostate enlargement) using the transurethral resection procedure, which involves removing prostate tissue. Patients with an elevated PSA or abnormal DRE will require a needle biopsy to confirm the diagnosis of cancer. Pathology of the dissected prostate tissue will provide the Gleason score which urologists use to determine prognosis.

 

Treatment for prostate cancer is based on the patient’s prostate cancer risk profile, age, health, and life expectancy. Laser interstitial thermal therapy (LITT) is being researched as a minimally invasive focal therapy option for treating localized prostate cancer. LITT uses continuous or pulsed thermal energy that enables thermal coagulation of tumor cells locally within the prostate gland while theoretically preserving the surrounding tissues, including the neurovascular and sphincter structures responsible for potency and urinary continence.

 

Based on an ECRI systematic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is inconclusive as a minimally invasive alternative treatment for the treatment of localized prostate cancer. Limited evidence from very small case series and systematic reviews (SRs) of other small case series suggests that LITT may be safe and without negative effects on sexual and urinary function in the short term (≤1 year) when used for localized prostate cancer; however, clinical trials have not yet demonstrated efficacy because studies have not assessed or reported on patient-oriented outcomes, such as 5-year overall survival or progression-free survival. Available studies are at high risk of bias, and results need confirmation in prospective controlled trials that compare LITT to other treatments for localized prostate cancer, such as radical prostatectomy, cryotherapy, and radiation therapy (external or radioactive seed implants).

 

Systematic Reviews

Author/YearPurpose of Systematic ReviewResources Searched and Inclusion CriteriaFindings Reported by AuthorsAuthors Conclusions
Walker et. al. (2018) "To systematically review erectile function (EF) outcomes following primary whole gland (WG) and focal ablative therapies for localized prostate cancer to ascertain whether the treatment modality or intended treatment volume affects the time taken to recover baseline EF." Cochrane library, Scopus, and PubMed was performed from inception to February 2017 for studies that reported on men with localized prostate cancer treated with primary, ablative therapy. Included 17 studies reporting on 1,297 patients. Of those, 4 case series reported on 35 unique patients undergoing focal photothermal (FP) therapy. “WG cryotherapy was associated with a significant decline in EF at 6 months with minimal improvement at 36 months. Baseline IIEF-15 [International Index of Erectile Function] of patients undergoing focal HIFU [high-intensity focused ultrasound] fell 30 points at 1 month but returned to baseline by 6 months. The remaining focal therapies demonstrated minimal or no effect on EF, but the men in these studies had small foci of disease. The review is limited by lack of randomized studies and heterogeneous outcome measures.”

 

“[FP], VTP [vascular targeted photothermal therapy], and IRE [irreversible electroporation] appeared to cause very little change from baseline though the men in these studies tended to have low volume lesions.”

“Most studies assessing the outcomes of focal therapy on sexual function were not of high quality, used heterogeneous outcomes, and had relatively short follow up, highlighting the need for more robustly designed studies using validated patient reported outcome measures for comparison. However, FT in general resulted in less effect on EF than WG ablation.

 

A systematic review & meta-analysis by Valerio et al. (2017) summarized the evidence regarding sources of energy employed in focal therapy for treatment of prostate tumors. Thirty-seven articles reporting on 3230 patients undergoing focal therapy were selected, with one of the focal therapies being laser interstitial thermal therapy (LITT). Four prospective Stage 1 to 2a studies evaluating LITT in 50 patients have been reported in literature. One study only included men with low-risk disease, whereas the other studies also included Gleason score ≤ 4+3, although risk stratification was not clearly reported. The median age was 63.5 yrs.; median PSA was 5.4 ng/ml; median follow-up was 4.5 months with all series including mandatory sampling after treatment. In the Stage 1 study, participants underwent radical prostatectomy, whereas in the other 3 studies participants underwent MR-transrectal ultrasound (TRUS) standard and/or targeted biopsy. Overall, the presence of significant and insignificant tumors was 4.8% and 22.2%, respectively. The probability of transition to secondary local treatment was 0%; overall and disease-specific survival, pad-free continence and potency preservation were 100% and 100%, respectively. No adverse events were reported in any study. The authors concluded that focal therapy seems safe and appears to offer good preservation of genito-urinary function. Tumor control in studies with intention to treat is encouraging, although this needs to be verified against standard of care in high quality comparative effectiveness trials.

 

Clinical Trials

Author/YearStudy Type and PatientsInterventionFindings Reported by AuthorsAuthors Conclusions
Eggener et. al. (2016) Phase II evaluation in 27 men with stage T1c-T2a prostate cancer. Inclusion criteria included prostate specific antigen (PSA) < 15 ng/ml or PSA density < 0.15 ng/ml3, Gleason score of 7 or less in 25% or less of biopsies, and MRI with 1 or 2 lesions concordant with biopsy-detected cancer MRI-guided focal laser ablation In the 27 men median age was 62 years and mean prostate specific antigen was 4.4 ng/ml. Biopsy Gleason score was 6 in 23 patients (85%) and Gleason 7 in 4 (15%). Seven men (26%) had low volume Gleason 6 disease outside the intended ablation zone(s). At 3 months 26 patients (96%) had no evidence of cancer on magnetic resonance imaging guided biopsy of the ablation zone. No significant I-PSS changes were observed (each p >0.05). SHIM was lower at 1 month (p = 0.03), marginally lower at 3 months (p = 0.05) and without a significant difference at 12 months (p = 0.38). At 12-month biopsy cancer was identified in 10 patients (37%), including in the ablation zone(s) in 3 (11%) and outside the ablation zone(s) in 8 (30%) with cancer in and outside the ablation zone in 1 The authors concluded that in select individuals with localized prostate cancer and visible MRI lesions, focal laser ablation has an acceptable morbidity profile and is associated with encouraging short-term oncologic outcomes. Significantly longer follow-up is mandatory to fully assess this treatment. Furthermore, the study was limited by lack of comparison group
Natarajan et. al. (2017) Prospective institutional review board approved pilot study.

Patients (n = 10) with intermediate- risk prostate cancer

Focal laser ablation using MRI -ultrasound fusion guidance Mean procedure time was 95 minutes (range 71 to 105). Posttreatment magnetic resonance imaging revealed a confined zone of nonperfusion in all 10 men. Mean zone volume was 4.3 cc (range 2.1 to 6.0). No CTCAE [Common Terminology Criteria for Adverse Events] grade 3 or greater adverse events developed and no changes were observed in urinary or sexual function. At 6 months magnetic resonance imaging-ultrasound fusion biopsy of the treatment site showed no cancer in 3 patients, microfocal Gleason 3 + 3 in another 3 and persistent intermediate risk prostate cancer in 4. Focal laser ablation of prostate cancer appears safe and feasible with the patient under local anesthesia in a urology clinic using magnetic resonance imaging-ultrasound fusion for guidance and thermal probes for monitoring. Further development is necessary to refine out of bore focal laser ablation and additional studies are needed to determine appropriate treatment margins and oncologic efficacy.

 

Summary of Evidence

The evidence is limited from very small series and systematic reviews, no published studies compare the use of laser interstitial thermal therapy (LITT) for localized prostate cancer with any other treatment for localized prostate cancer. Included studies had much heterogeneity in terms of patient selection and disease severity. Prospective controlled trials comparing LITT to standard treatments for localized prostate cancer (e.g., prostatectomy, radiation therapy, cryotherapy) and reporting on long-term (>5 year) patient-oriented outcomes, including overall survival, progression-free survival, urinary function, sexual function, and quality of life, are needed. Studies should report results separately for each risk category of diagnosed prostate cancer. A review of  the current NCCN guideline for Prostate Cancer Version 3.2020 mentions laser ablation as an emerging local therapy, however, the NCCN Panel does not include this as local therapy option for the treatment of localized prostate cancer in initial disease or recurrent settings.  The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Laser Interstitial Thermal Therapy for the Treatment of Breast Cancer

Breast cancer is the most common malignancy in women and a leading cause of cancer mortality. Risk factors for developing breast cancer include family history, presence of known predisposing mutations, age, and low or late exposure to pregnancy hormones (e.g., nulliparity). Conventional treatment of early-stage breast cancer involves mastectomy or lumpectomy typically followed by five to seven weeks of daily external beam radiation therapy of the whole breast. Some women with early-stage breast cancer who undergo lumpectomy are candidates for accelerated partial-breast irradiation, which permits delivery of high doses of radiation directly to the lumpectomy site over one week. Surgical resection can cure many cases of early-stage breast cancer but involves surgical risks and may result in significant disfigurement and a heavy psychosocial burden for the patient. Several energy-based, minimally invasive ablative techniques have emerged as potential alternatives to surgical resection of early-stage tumors, but experts disagree on their effectiveness, safety, and optimal utilization. Laser interstitial thermal therapy (LITT) is a minimally invasive thermal ablation technique used to treat multiple tumor types. In patients with small, early-stage breast tumors, LITT is intended as an alternative to lumpectomy or mastectomy in patient’s ineligible for surgical resection.

 

Based on an ECRI systematic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is inconclusive as a minimally invasive alternative treatment for the treatment of breast cancer. Available evidence on LITT for early-stage breast cancer consists of small case series, some of which are synthesized in systematic reviews (SRs). Findings are at high risk of bias and are of unclear significance because of low statistical precision and because most patients underwent sequential LITT and resection, so the contribution LITT made to the outcomes cannot be discerned. Prospective studies with a parallel control group are needed to validate LITT as an alternative to surgery and to compare LITT with other minimally invasive techniques.

 

Systematic Reviews

Author/YearSystematic Review PurposeResources Searched and Inclusion CriteriaFindingsConclusions Reported by Authors
Peek et. al. (2016) To assess the current evidence for clinical outcomes with minimally invasive ablative techniques in the non-surgical treatment of breast cancer. A systematic search of the literature was performed using PubMed and Medline library databases to identify all studies published between 1994 and May 2016. Studies were considered eligible for inclusion if they evaluated the role of ablative techniques in the treatment of breast cancer and included ten patients or more. Studies that failed to fulfil the inclusion criteria were excluded Identified 63 studies including 1608 patients whose breast tumours were treated with radiofrequency (RFA), high intensity focussed ultrasound (HIFU), cryo-, laser or microwave ablation. Fifty studies reported on the number of patients with complete ablation as found on histopathology and the highest rate of complete ablation was achieved with RFA (87.1%, 491/564) and microwave ablation (83.2%, 89/107). Short-term complications were most often reported with microwave ablation (14.6%, 21/144). Recurrence was reported in 24 patients (4.2%, 24/570) and most often with laser ablation (10.7%, 11/103). The shortest treatment times were observed with RFA (15.6 ± 5.6 min) and the longest with HIFU (101.5 ± 46.6 min) Minimally invasive ablative techniques are able to successfully induce coagulative necrosis in breast cancer with a low side effect profile. Adequately powered and prospectively conducted cohort trials are required to confirm complete pathological ablation in all patients

 

Clinical Trials

Author/YearStudy Type and PatientsInterventionFindings Reported by AuthorsAuthors Conclusions
Nori et.al. (2018) Single-center retrospective study; 12 consecutive patients underwent percutaneous US-guided laser ablation as radical treatment of primary inoperable unifocal BC Investigate the feasibility and safety of percutaneous US-guided laser ablation for unresectable unifocal breast cancer (BC). At median follow-up of 28.5 months (range 6-51), no residual disease or progression occurred; the overall success rate for complete tumor ablation was therefore 100%. No significant operative side effects were observed, with only 2 (13.3%) experiencing slight to mild pain during the procedure, and all patients complained of a mild dull aching pain in the first week after procedure. Laser ablation is a feasible, minimally invasive, and cost-effective alternative for a subset of patients affected by small lesions, who are not eligible to the standard surgical approach, as well as for patients who refuse surgery. However, further larger prospective studies are strongly needed in order to confirm our preliminary results
Schwartzberg et. al. (2018) Open-label, phase 2 institutional review board (IRB)-approved, multicenter clinical trial; 61 women 18 to 80 years of age with a single focus of percutaneous biopsy-proven IDC measuring 20 mm or smaller were eligible for enrollment in the study. The cancer had to be visible by mammography, ultrasound, or both as a mass 20 mm or smaller or as a single cluster of microcalcifications 10 mm or smaller. The lesion had to be 5 mm or further from the skin and chest wall. Any intraductal component could not exceed 25% The primary goal of this research study was to evaluate the performance of a newly improved percutaneous laser ablation device in achieving complete pathologic tumor ablation in a multicenter study. A secondary aim was to measure the performance of imaging in evaluation of complete tumor ablation. Tissue pathology at surgical excision was used as the gold standard In this study, 61 patients were reported as the intention-to-treat cohort for determination of PLA efficacy. Of these 61 patients, 51 (84%) had complete tumor ablation confirmed by pathology analysis. One subject’s MRI imaging was not performed per protocol, which left 60 subjects evaluable for MRI pathology correlation. Five patients (8.3%) had residual IDC shown by both MRI and pathology. Post-ablation discordance was noted between MRI and pathology, with four patients (6.7%) false-positive and four patients (6.7%) false-negative. The negative predictive value (NPV) of MRI for all the patients was 92.2% (95% confidence interval [CI], 71.9–91.9%). Of the 47 patients (97.9%) with tumors 15 mm or smaller, 46 were completely ablated, with an MRI NPV of 97.7% (95% CI, 86.2–99.9%) Percutaneous laser therapy, which works by focal destruction, is a potential alternative to traditional breast cancer conservation surgery for treatment of early-stage IDC. Strong correlations exist between post-ablation MRI findings and pathologic alterations in CK8/18, ER, and Ki67 staining. Clinical trials that evaluate PLA efficacy and outcome in the absence of subsequent surgical resection are necessary to further determine the potential of this breast cancer therapy

 

Summary of Evidence

Case series individually reviewed or synthetized in a systematic review provide only low-quality evidence on laser interstitial thermal therapy (LITT) safety and effectiveness for early-stage breast cancer. Because the studies were all small and lacked control groups, reported findings are at high risk of bias. Moreover, long-term survival and freedom from recurrence rates reported may not be attributed to LITT alone because patients underwent subsequent surgical resection. Control groups that include surgery-only controls are needed to provide this data and to validate perioperative LITT outcomes reported in available studies. Similarly, direct comparison of LITT and other minimally invasive techniques in prospective studies with parallel treatment groups is needed. Independent studies synthetized in the review by Peek et al. suggest that LITT may not perform as well as RFA, MWA, or HIFU; thus, additional prospective studies to identify the optimal approach for patients with unresectable early-stage cancer are warranted. In 2018, the American Society of Breast Surgeons issued a consensus guideline on the use of transcutaneous and percutaneous ablation for the treatment of benign or malignant tumors of the breast that included the following: “At the present time, cryoablation is approved for treatment of soft tissue malignancies. However, there is emerging data from clinical trials utilizing percutaneous ablative therapies for patients with early stage breast cancer without surgical excision. Techniques being evaluated include ablation by focused ultrasound, laser, cryotherapy, microwave, and radiofrequency.  Participation in registries and clinical trials evaluating the use of these technologies with and without surgical excision of a breast malignancy is advised as early data emerges on their efficacy.” A review of the current NCCN guideline Breast Cancer Version 6.2020 does not address laser thermal therapy or laser ablation as treatment for breast cancer.

 

Laser Interstitial Thermal Therapy for the Treatment of Osteoid Osteoma

Osteoid osteomas are benign tumors composed of cells that produce bone matrix (osteoblasts), a nidus (origin site), and very loose vascular connective tissue. The tumors are typically smaller than 1.5 to 2.0 cm in size, can occur anywhere in the skeletal system, and may involve single or multiple bones. The most common sites for primary osteoid osteomas include the intercapsular regions of the hip and the diaphyseal parts of the tibia and humerus. The principal symptoms in initial and recurrent disease are pain, described as continuous, deep, aching, and intense; these symptoms may vary in severity. The pain is localized to the site of the tumors.

 

Osteomas are often initially misdiagnosed as osteomyelitis, Brodie abscesses, eosinophilic granulomas, or other benign cysts due to the disease’s atypical presentation. Diagnosis of osteoid osteoma may take years (11.8 to 36.0 months on average) due to the disease’s

similarities to other bone diseases based on radiographic evidence. Other diagnostic methods, including radionuclide scanning, arteriography, CT, and MRI, can be used when radiographic findings are not informative. Pathologic examination is the only way to confirm a diagnosis of osteoid osteoma. To do this, a pathologist identifies a discrete central nidus, cherry-red in color, and smaller than 1 cm in diameter that can be extracted from the surrounding dense reactive bone.

 

Physicians initially recommend nonsurgical interventions for pain management, including the use of aspirin or nonsteroidal anti-inflammatory drugs, for primary osteomas. Surgery is typically reserved for patients whose disease does not respond to conservative treatment.

Complete excision of the nidus provides complete pain relief and is curative in most cases; however; treatment success highly depends on the surgeon’s ability to identify the exact location of the nidus. If the surgeon is unable to locate the nidus before surgery using advanced imaging techniques, the nidus may not be located intraoperatively, resulting in tissue removal larger than the tumor itself. Removing excessive bone during surgery may lead to the need for internal fixation, bone grafting, or disability if weight-bearing bones are affected. Surgical procedures for nidus removal include en-bloc resection, unroofing and curettage, prophylactic internal fixation, and spinal fusion. Surgeons may not recommend surgical intervention in patients in whom the nidus is difficult to reach or for whom surgery may cause increased morbidity or disability. Laser interstitial thermal therapy (LITT) is a minimally invasive tissue ablation technique used to treat multiple tumor types, including osteoid osteomas.

 

LITT is intended as an alternative to conventional surgical osteoid osteoma resection in patients with symptoms (e.g., pain, disability) not controlled with medical therapy.

 

Based on an ECRI systematic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is inconclusive as a minimally invasive alternative treatment for the treatment of osteoid osteomas. Limited evidence from case series at high risk of bias suggests that LITT is safe and that symptoms were reduced in most patients at 1-month to 1-year follow-up; however, these studies are at too high a risk of bias to be conclusive. A single nonrandomized comparative study reports on perioperative outcomes, and only small case series report on long-term (≥1 year) patient outcomes. Validation is needed in long-term trials comparing LITT to other treatments, such as surgical removal of the nidus and radiofrequency thermal ablation.

 

Clinical Trials

Nonrandomized Controlled/Comparative Studies

Author/YearStudy Type and PatientsIntervention Findings Reported by Authors Authors Conclusions
Wu et. al. (2017) A total of 72 cases of children with osteoid osteoma. Selected patients were then divided into a control group and an observational group. The control group comprised 24 cases of boys and 13 cases of girls. The children were aged 3–16 years (average, 10.5±4.6 years), with a disease duration of 1–5 months (average, 2.2±1.3 months), and a maximum lesion diameter of 0.4–1.3 cm (average, 0.8±0.3 cm). The observational group included 22 boys and 14 girls, aged 3.5–15 years (average, 10.2±4.5 years), with a duration of 1.5–5 months (average, 2.6±1.5 months), and a maximum lesion diameter of 0.5–1.4 cm (average, 0.7±0.4 cm). Each group comprised 36 cases according to the method of treatment. Compare and analyze the difference between minimally invasive percutaneous laser ablation and open surgery in our center to provide reference for clinical treatment. The control group underwent conventional open surgery while the observational group underwent minimally invasive CT guided percutaneous laser ablation. Effects of both operations were compared. The operation duration, blood loss and plaster fixation duration of the observational group were significantly less than those of the control group. The postoperative pain score (VAS) at 1 day and 7 days were significantly lower than that of the control group, the differences were statistically significant (P<0.05). The lesion resection rate, effective rate of bone hyperplasia, effective rate of swelling and effusion and total effective rate of the observational group were significantly higher than those of the control group, the differences were statistically significant (P<0.05). Incidence of adverse reactions of observational group was significantly lower (P<0.05) than that of the control group. The difference was not significant when comparing 1-year recurrence rate for the two groups. The minimally invasive percutaneous laser ablation has better surgery effects compared with open surgery in the treatment of children with osteoid osteoma.

Additional large number of samples, randomized controlled clinical trial should still be conducted to further discuss the safety, effectiveness, indications of osteoid osteoma with minimally invasive operation.

 

Case Series

Author/YearStudy Type and PatientsInterventionFindings Reported by Authors Authors Conclusions
Tsoumakidou et. al. (2016) Retrospective; 57 patients (40 men and 17 women) with spinal osteoid osteoma (OO) Evaluate the safety and efficacy of percutaneous image-guided laser photocoagulation for the treatment of spinal osteoid osteoma (OO) in proximity to neural structures OO was in the vertebral body for 18 of 57 patients, the neural arch for 21 of 57 patients, and the articular process for 18 of 57 patients. Mean nidal diameter was 8 mm, and the mean distance from the closest neural structure was 6.6 mm (minimum distance, ≤5 mm in 35 of 57 patients). In 35 of 57 patients, no cortical coverage was present between the nidus and neural structure in danger. Mean total energy delivered was 1271 J (2-watt continuous power mode). Thermal insulation (carbon dioxide and/or hydrodissection), temperature monitoring, and electrostimulation were used in 42, 24, and one patient, respectively. Primary clinical success at 1 month was 98.2%. Total recurrence rate was 5.3%. All recurrences were addressed percutaneously. Secondary success rate was 100%. One-year follow-up is available in 54 of 57 patients. No major complications were noted Spinal OO can be safely and effectively treated with percutaneous laser photocoagulation. In cases that are less than 8 mm to 10 mm distance and in the absence of cortical coverage, thermal protection techniques of the neural structures should be used
Kachare et. al. (2016) Study of 30 cases of osteoid osteomas in various bone diagnosed on various modalities (age not stated) CT-guided laser interstitial thermal therapy Over the period of 5 years 30 cases of osteoid osteomas in various bones diagnosed on various modalities were treated by CT guided LASER ablation. Bone wise distribution of cases was spine (3), upper end of femur (11), lower end of femur (6), upper end of tibia (4), upper end of humerus (3), lower end of radius (2) and calcaneum (1). 22 patients were treated under spinal and regional anesthesia and 8 patients were treated under short general anesthesia. All the patients were treated on day care basis. The LASER fiber was inserted in the nidus under CT guidance through bone biopsy needle and 1800 joules energy delivered in the lesion continuous mode.

29 (96%) patients have complete relief of pain in twenty-four hours after LASER ablation, One week after treatment all 30 patients were pain free. No neurologic complication was observed in any of our patients with spinal osteoid osteomas.

CT guided laser ablation is a safe, simple and effective method of treatment for osteoid osteoma

 

Summary of Evidence

Limited evidence from case series and a single nonrandomized comparative study are at high risk of bias for one or more of the following reasons: small sample size, lack of control groups and randomization, single-center focus, and/or heterogeneous patient populations (ages and tumor sites varied widely). Studies also reported relatively short follow-up (1 to 13.6 months). Only one study compared laser interstitial thermal therapy (LITT) with conventional surgery and had heterogeneity among patients regarding tumor location, which may affect pain levels and physical function. Studies comparing LITT to conventional surgical procedures for removing osteoid osteomas (en-bloc resection, unroofing and curettage, prophylactic internal fixation, and spinal fusion) as well as other thermal ablative techniques (radiofrequency thermal ablation) are needed to assess longer-term patient-oriented LITT outcomes, including pain level, physical function, and quality of life. A review of the current NCCN guideline Bone Cancer Version 1.2021 the guideline does not address laser thermal therapy or laser ablation treatment in bone cancers. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Laser Interstitial Thermal Therapy for the Treatment of Epilepsy

Epilepsy is a neurologic disorder characterized by recurrent, unprovoked, excessive electrical discharges from the central nervous system that result in recurring seizures. The seizure characteristics depend on the location of the epileptic discharges in the cerebral cortex but are generally sudden and violent in onset and short in duration. Neurologists characterize seizures as generalized if they originate in both brain hemispheres (typically leads to major motor seizures) and as partial if they originate in discrete foci (with local or generalized spread). Epilepsy’s etiology is complex and may be classified as idiopathic (spontaneous, often generalized seizures in patients with or without family history), symptomatic (seizures caused by specific brain lesions), or syndromic (seizures that follow a predictable course, often with a known genetic component and associated features).

 

The majority of patients with epilepsy can use medication to adequately control their condition. However, about 20% to 30% of patients have medically refractory epilepsy, defined as recurrent seizures despite optimal treatment for two to three years. Many patients with medically refractory epilepsy may benefit from surgery, provided their seizure focal points can be located and resected without causing harm to critical areas of the brain. Surgical decisions are based on magnetic resonance imaging and electroencephalography evaluations with noninvasive scalp electrodes used to locate the focal area responsible for the seizures. Despite advances, surgical resection still involves significant risks of complications and neurological sequelae, and some locations remain out of reach to surgical resection. Major emerging approaches intended to address these limitations include stereotactic ablative radiosurgery (e.g., Gamma Knife), neurostimulation with deep or cortical brain electrodes, magnetic resonance-guided focused ultrasound ablation, stereotactic radiofrequency ablation, and laser interstitial thermal therapy (LITT).

 

Laser interstitial thermal therapy (LITT) uses fiberoptic tools to achieve minimally invasive tissue ablation in various neurologic and oncologic applications. In patients with epilepsy that does not respond to medication (i.e., medically refractory), surgeons may use LITT to discreetly destroy brain foci where seizures originate, as a minimally invasive alternative to surgical resection and in patients with foci inaccessible with conventional surgery tools.

 

Based on an ECRI systematic review (2019), the available evidence on laser interstitial thermal therapy (LITT) is somewhat favorable for the treatment of medically refractory epilepsy. Systematic reviews (SRs) with meta-analysis of low-quality, before-and-after cohort studies shows that LITT results in freedom from seizures up to 2 years in about 60% of treated patients with medically refractory epilepsy; complications were reported in about 20% to 25% of LITT patients. LITT appears to be as safe and effective as stereotactic radiosurgery (e.g., Gamma Knife®). Nonrandomized studies suggest LITT may be safer than open surgery, but larger studies are needed to validate these data. Studies comparing LITT and neurostimulation techniques would also be useful. Epilepsy management guidelines have yet to address LITT.

 

Systematic Reviews

Author/YearPurpose Resources Searched and Inclusion Criteria Findings Reported by Authors Authors Conclusions
Grewal et. al. (2019) To systematically review the current literature summarizing the effects of MRgLITT [magnetic resonance-guided laser interstitial thermotherapy] and SRS [stereotactic radiosurgery] in the management of [mesial temporal lobe epilepsy] and to compare, by meta-analysis, the seizure freedom, complications, and reoperation outcomes MEDLINE, EMBASE, Cochrane Central, and Scopus in May 2018 for clinical studies reporting on 1-year or longer outcomes in patients who underwent LITT or SRS for medically refractory mesial lobe epilepsy. Included 17 studies (n = 404), of which 9 addressed LITT (n = 239) "We found that the overall seizure freedom rate was comparable between the 2 procedures (MRgLITT 50%, 95% confidence interval [CI] 44% to 56%, vs. SRS 42%, 95% CI 27% to 59%, P = 0.39). Similarly, among patients with lesional pathologic conditions only, the seizure freedom rate was comparable between the 2 procedures (MRgLITT 62%, 95% CI 48% to 74%, vs. SRS 50%, 95% CI 37% to 64%, P = 0.23). Compared with SRS, MRgLITT was associated with lower complication rates (MRgLITT 20%, 95% CI 14% to 26% vs. SRS 32%, 95% CI 20% to 46%, P = 0.06) but similar reoperation rates (15%, 95% CI 9% to 22% vs. 27%, 95% CI 12% to 46%, P = 0.31).”

“We found the overall quality of evidence for most outcomes obtained through this indirect meta-analysis to be low as per the GRADE [Grading of Recommendations Assessment, Development and Evaluation] assessment

We found similar outcomes and complications between the 2 procedures.
Xue et. al. (2019) To undertake a systematic review of the literature with meta-analysis of the data from published studies to assess the effectiveness of [MRgLITT]) in treatment-resistant epilepsy PubMed, MEDLINE, and EMBASE in May 2018 for clinical studies reporting outcomes of LITT in patients with medically refractory epilepsy. Included 16 studies (n = 269) [overlap 200] The studies included postoperative follow-up of between 7 days to 51 months… Eight publications focused on mesial temporal lobe epilepsy (MTLE), three on temporal lobe epilepsy (TLE), and another three publications on focal epilepsy.”

“The prevalence of Engel Class I (free from disabling seizures) after ablation were reported in 12 studies that included a total of 189 individuals. The pooled prevalence of patients who achieved postoperative freedom from epileptic seizures was 61% (95% CI, 0.54–0.68). Estimates ranged from 41–88% and low study heterogeneity were found (I2=14.5%; P=0.302)

Seven studies reported postoperative complications, with a total of 26 complications in 101 patients with drug-resistant epilepsy. The pooled prevalence was 24% (95% CI, 0.16–0.32) and estimates ranged from 15–43%. Low study heterogeneity was detected (I2=0%; P=0.629)

Meta-analysis of data from 16 studies that included 269 patients with treatment-resistant epilepsy showed that MRI-guided LITT significantly reduced the frequency of seizures and reduced postoperative complications, supporting the safety and effectiveness of MRI-guided LITT in the treatment of drug-resistant epilepsy
Hoppe and Helmstaedter (2018) This review extends our former more general review on LiTT for epilepsy surgery with a special focus on children aged below 18 years PubMed in August 2018 for clinical studies of LITT in pediatric patients with epilepsy. Included 25 case series and case reports (n = 179) [overlap 62]. Hypothalamic hamartomas (HH) represented the most frequent indication (64.2%) while therapeutic evidence for other more frequent etiologies underlying severe focal childhood epilepsies (e.g. focal cortical dysplasia, mesiotemporal sclerosis) is still scarce (n<20). For the published cases, the rate of severe complications was 3.4% and the overall complication rate was 23.5%. The seizure freedom rate (Engel class 1) was 57.5% (including patients with early follow-up and repeat thermoablations). None of the studies included the systematic evaluation of the cognitive outcome Only limited evidence for the therapeutic outcome of LiTT in this population is available so far. This concerns both the quantity of published studies and reported patients as well as the scientific quality of these publications (as these are uncontrolled case series reports)

 

Clinical Trials

Nonrandomized Comparison Studies

Author/YearStudy Type and PatientsIntervention Findings Reported by Authors Authors Conclusions
Hale et. al. (2019) Retrospective study of 26 pediatric patients with insular cortex epilepsy Laser interstitial thermal therapy (LITT) (n = 14) or open surgical resection (n = 12) The average age in our cohort was 10.3 yr, 58% were male, and the average length of follow-up was 2.43 ± 0.20 (SEM) yr. Complications in patients undergoing either LITT or open resection were mostly minimal and generally transient. Forty-three percent of patients who underwent LITT were Engel Class I, compared to 50% of patients who underwent open insular resection Both surgical resection and LITT are valid management options in the treatment of medically refractory insular/opercular epilepsy in children. Although LITT may be a less invasive alternative to craniotomy, further studies are needed to determine its noninferiority in terms of complication rates and seizure freedom
Petito et. al. (2018) Retrospective, single-center study of 54 patients with medically refractory epilepsy LITT (n = 33) or open surgical resection (n = 21) A discrete lesion was present on brain magnetic resonance imaging (MRI) in 27/32 (84.4%) of SLA [stereotactic laser ablation; i.e., LITT] patients compared with 7/20 (35%) of resection patients with a normal MRI. Overall, 55-60% of patients became seizure-free (SF). Four of five patients with initial failure to SLA became SF with subsequent resection surgery. Complications were more frequent with resection although SF outcomes did not differ (Chi square; p=0.79). Stereotactic laser ablation patients were older than those with resections (47.0 years vs. 35.4 years, p=0.001). The mean length of hospitalization prior to discharge was shorter for SLA (1.18days) compared with open resection (3.43days; SD: 3.16 days) (p=0.0002) We now use SLA as a first line therapy at our center in patients with lesional temporal lobe epilepsy (TLE) before resection. Seizure-free outcome with SLA and resection was similar but with a shorter length of stay. Long-term follow-up is recommended to determine sustained SF status from SLA
Lam et. al. (2017) Retrospective, multicenter study of 58 children with medically refractory epilepsy secondary to hypothalamic hamartoma LITT (n = 16) or open surgical resection (n = 42) The TCH [Texas Children’s Hospital, LITT group] cohort had an average hospital LOS [length of stay] of 2.1 days, with a range of 1 to 8 days. The KID [Kids’ Inpatient Database, surgery group] cohort had an average LOS of 8.4 days (range: 3–32 days). The average hospitalization charges for the TCH group were $65,525, with a standard deviation (SD) of $19,390). All values are reported in 2013 U.S. dollars. The KID group average charges were more than double that of the TCH group at $145,760 (SD: $84,252). Based on cost-to charge ratios, the average cost per stay in KID ($42,450 ± $23,115) was also double the cost at TCH ($23,589 ± $6,981) Our study has shown that children undergoing SLA for [hypothalamic hamartoma] have a shorter length of stay and lower cost of hospitalization compared with those who underwent craniotomy and resection for the same diagnosis. Together with previous findings from our institution regarding the safety and efficacy of SLA, our findings suggest that SLA may represent an attractive alternative to craniotomy for the treatment of refractory epilepsy secondary to [hypothalamic hamartoma].”
Drane et. al. (2015) Prospective, single-center study of 58 adult patients with anteromedial TLE LITT (n = 19) or open surgical resection (n = 39) [Boston Naming Test] performance declines were significantly greater for the dominant TLE patients undergoing open resection versus SLAH [stereotactic laser amygdalohippocampotomy; i.e., LITT] for naming famous faces and common nouns (F=24.3, p<.0001, η2=.57, & F=11.2, p<.001, η2=.39, respectively), and for the nondominant TLE patients undergoing open resection versus SLAH for recognizing famous faces (F=3.9, p<.02, η2=.19). When examined on an individual subject basis, no SLAH patients experienced any performance declines on these measures. In contrast, 32 of the 39 undergoing standard surgical approaches declined on one or more measures for both object types (p<.001, Fisher’s exact test).1 Our initial experience with SLAH suggests that it is a promising surgical approach that appears to minimize aspects of the cognitive morbidity associated with open surgical resection

 

Case Series

Author/YearStudy Type and PatientsInterventionFindings Reported by Authors Authors’ Conclusions
Wu et. al. (2019) Retrospective, multicenter study of 234 patients with medically temporal lobe epilepsy (mTLE) LITT (laser interstitial thermal therapy) Ablations including more anterior, medial, and inferior temporal lobe structures, which involved greater amygdalar volume, were more likely to be associated with Engel class I outcomes. At both 1 and 2 years after LITT, 58.0% achieved Engel I outcomes. LITT is a viable treatment for mTLE in patients who have been properly evaluated at a comprehensive epilepsy center. Consideration of surgical factors is imperative to the complete assessment of LITT.

 

In 2018, Kang et. al.  published an epileptologist’s view on laser interstitial thermal ablation treatment of temporal lobe epilepsy. A procedure called laser interstitial thermal ablation has been utilized to treat drug resistant epilepsy. With this technique, a probe is stereotactically inserted into a target structure responsible for seizures, such as mesial temporal lobe, hypothalamic hamartoma, or a small malformation of cortical development, and the tip is then heated by application of laser energy to ablate structures adjacent to the probe tip. This procedure has the advantage of selectively targeting small lesions responsible for seizures and is far less invasive than open surgery with shorter hospitalization, less pain, and rapid return to normal activities. Initial results in mesial temporal lobe epilepsy are promising, with perhaps half of patients becoming free of seizures after the procedure. Neuropsychological deficits appear to be reduced because of the smaller volume of ablated cortex in contrast to large resections. More research must be done to establish optimal targeting of structures for ablation and selection of candidates for surgery, and more patients must be studied to better establish efficacy and adverse effect rates.

 

The Epilepsy Foundation of America website includes information for Professionals which addresses magnetic resonance-guided laser interstitial thermal therapy (MRgLITT). It states the best candidates for MRgLITT are patients with a well-defined epileptogenic focus. When focal seizures are uncontrolled by antiseizure drugs, a solitary lesion < 2 cm on high – resolution MRI of the brain and concordant presurgical evaluation is the optimal preoperative situation for LITT.

 

Summary of Evidence

The available evidence on laser interstitial thermal therapy (LITT) is somewhat favorable for the treatment of medically refractory epilepsy. Systematic reviews (SRs) with meta-analysis are of low-quality, however, before-and-after cohort studies shows that LITT results in freedom from seizures up to 2 years in about 60% of treated patients with medically refractory epilepsy; complications were reported in about 20% to 25% of LITT patients. LITT appears to be as safe and effective as stereotactic radiosurgery (e.g., Gamma Knife®) and nonrandomized studies suggest LITT may be safer than open surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcomes.

 

Laser Interstitial Thermal Therapy for the Treatment of Radiation Necrosis

Cranial irradiation (brain irradiation) is used to treat patients with primary or metastatic brain tumors and as prophylaxis for selected patients at high risk of neoplastic involvement of the nervous system. Tissue necrosis is a distinct syndrome of radiation toxicity, thought to be the consequence of vascular endothelial cell damage, resulting in fibrinoid necrosis of small vessels and direct brain parenchymal necrosis.

 

Treatment-induced brain tissue necrosis (also referred to as radiation necrosis) is a serious complication that typically develops one to three years after radiation, although the range is quite broad and cases have been reported more than 10 years after radiation. The dose that causes a higher than 5 percent risk of focal radiation necrosis using conventional 2 gray (Gy) fractionation is usually estimated to be 72 Gy, but this may be an oversimplification, and the dose that causes necrosis may vary by region of the brain as well. Tissue necrosis is more likely to occur when high doses per fraction are administered and perhaps with concurrent chemotherapy or radiosensitizers. The risk of tissue necrosis after stereotactic radiosurgery (SRS) has been reported to be higher, with a steep dose-response relationship. Tissue necrosis typically develops at or adjacent to the original site of tumor, the location that received the highest radiation dose. Tissue necrosis can also develop in part of the normal brain parenchyma that was included in the treatment field of a tumor outside the brain, such as temporal lobe necrosis that develops in some patients treated for nasopharyngeal cancer or clival chordoma. In this setting, brain tissue necrosis typically results in new focal neurologic signs, and imaging studies such as computed tomography (CT) or magnetic resonance imaging (MRI) may show an enhancing mass lesion with edema.

 

The clinical course of brain tissue necrosis is highly variable. No causal therapies have been established, and management is primarily symptomatic. The treatment decisions require a balance between the often-competing goals of symptom control and avoidance of side effects. In some cases, tissue necrosis is an asymptomatic, self-limited process that can be managed conservatively without intervention. In patients who are symptomatic, initial treatment includes a moderate dose of glucocorticoid (e.g., 4 to 8 mg of oral dexamethasone daily), which usually produces prompt symptomatic improvement by reducing cerebral edema. Once symptoms are controlled, glucocorticoids can then be gradually tapered over the course of several weeks. Follow-up imaging after one to two months is generally recommended. In patients who do not achieve symptomatic response to glucocorticoids, or when glucocorticoids cannot be tapered without return of symptoms, surgical resection of the necrotic tissue is sometimes required particularly in cases where there is diagnostic uncertainty as to whether the radiographic changes are indicative of tumor progression or treatment – induced tissue necrosis, or in patients with severe necrosis who have contraindications to bevacizumab. Surgery can provide palliative benefit by reducing mass effect and decreasing steroid requirements postoperatively. Minimally invasive laser interstitial thermal therapy (LITT) has been explored as therapeutic intervention in the treatment of radiation necrosis.

 

Rao et. al. (2014) noted that that enhancing lesions that progress after stereotactic radiosurgery are often tumor recurrence or radiation necrosis.  Magnetic resonance-guided laser interstitial thermal therapy (MRIgLITT) is currently being explored for minimally invasive treatment of intracranial neoplasms/radiation necrosis. Patients with recurrent metastatic intracranial tumors or radiation necrosis who had previously undergone radiosurgery and had a KPS of greater than 70 were eligible for LITT.  A total of 16 patients underwent a total of 17 procedures.  The primary endpoint was local control using MRI scans at intervals of greater than 4 weeks.  Radiographic outcomes were followed-up prospectively until death or local recurrence (defined as greater than 25 % increase in volume compared with the 24-hour post-procedural scan).  A total of 15 patients (age of 46 to 82 years) were available for follow-up.  Primary tumor histology was non-small-cell lung cancer (n = 12) and adenocarcinoma (n = 3).  On average, the lesion size measured 3.66 cm (range of 0.46 to 25.45 cm); there were 3.3 ablations per treatment (range of 2 to 6), with 7.73-cm depth to target (range of 5.5 to 14.1 cm), ablation dose of 9.85 W (range of 8.2 to 12.0 W), and total ablation time of 7.43 minutes (range of 2 to 15 minutes).  At a median follow-up of 24 weeks (range of 4 to 84 weeks), local control was 75.8 % (13 of 15 lesions), median progression-free survival was 37 weeks, and overall survival was 57 % (8 of 14 patients).  Two patients experience recurrence at 6 and 18 weeks after the procedure.  Five patients died of extracranial disease progression; 1 patient died of neurological progression elsewhere in the brain.  The authors concluded that MRI-guided LITT is a well-tolerated procedure and may be effective in treating tumor recurrence/radiation necrosis.  This was a small, single-arm, non-randomized study.  Moreover, the authors stated that "larger studies with longer follow-up that include patient quality of life, decreased steroid dependence and neurological symptoms as end-points are necessary to confirm these findings and better define the appropriate patient for this therapy".

 

Rammo et.al. (2018) noted that cerebral radiation necrosis (CRN) is a known complication of radiation therapy; and therapeutic options are limited and include steroids, bevacizumab, and surgery.  This study examined the safety of laser interstitial thermal therapy (LITT) for CRN and identified the pattern of post-ablation volume change over time.  Patients undergoing LITT for tumor treatment at Henry Ford Hospital between November 2013 and January 2016 with biopsy-confirmed CRN were prospectively collected and retrospectively reviewed with attention to ablation volume, survival, demographic data, steroid dose, and complications.  Imaging occurred at set intervals beginning pre-ablation.  A total of 10 patients with 11 ablations were evaluated; 4 patients had a primary diagnosis of high-grade glioma, while 6 had metastatic lesions.  An average of 86 % of CRN volume was ablated.  Ablation volume increased to 430 % of initial CRN volume at 1 to 2 weeks before decreasing to 69 % after 6 months.  No patient had a decline in baseline neurological examination while in the hospital; 4 patients developed delayed neurological deficits likely due to post-operative edema, of which 3 improved back to baseline.  The 6-month survival was 77.8 % and the 1-year survival was 64.8 % based on Kaplan-Meier curve estimates.  The authors concluded that LITT was a relatively safe treatment for CRN, providing both a diagnostic and therapeutic solution for refractory patients.  Significant increase in ablation volume was noted at 1 to 2 months, gradually decreasing in size to less than the original volume by 6 months.  The authors stated that further studies are needed to better-define the role of LITT in the treatment of CRN.

 

Summary of Evidence

Based on the limited evidence in the peer reviewed medical literature regarding MRI-guided laser interstitial thermal therapy (MRIgLITT) for the treatment of radiation necrosis, larger studies with longer follow-up that include patient quality of life, decreased steroid dependence and neurological symptoms as end points are necessary to confirm findings and better define the appropriate patients for this therapy. The evidence is insufficient to determine the effects of the technology on health outcomes. 

 

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

Prostate Cancer Version 3.2020
Other Local Therapies

Many therapies have been investigated for the treatment of localized prostate cancer in the initial disease and recurrent settings, with the goals of reducing side effects and matching the cancer control of other therapies. Cryotherapy or other local therapies are not recommended as routine primary therapy for localized prostate cancer due to lack of long-term data comparing these treatments in radiation or radical prostatectomy. At this time, the panel recommends only cryosurgery and high-intensity focused ultrasound (HIFU; category 2B) as local therapy options for RT recurrence in the absence of metastatic Disease.

 

Other emerging local therapies, such as focal laser ablation and vascular targeted photodynamic (VTP) therapy have also been studied.

 

The NCCN Guideline mentions laser ablation as an emerging local therapy but currently does not recommend as treatment for prostate cancer.

 

Central Nervous System Cancers Version 3.2020

The NCCN Guideline does not address laser thermal therapy or laser ablation as treatment in CNS cancers

 

Bone Cancer Version 1.2021

The NCCN Guideline does not address laser thermal therapy or laser ablation as treatment in bone cancers

 

Non-Small Cell Lung Cancer Version 1.2021

The NCCN Guideline does not address laser thermal therapy as treatment for lung cancer

 

Small Cell Lung Cancer Version 1.2021

The NCCN Guideline does not address laser thermal therapy as treatment for lung cancer

 

Hepatobiliary Cancers Version 5.2020

The NCCN Guideline does not address laser thermal therapy or laser ablation as treatment in hepatobiliary cancers

 

Breast Cancer Version 6.2020

The NCCN Guideline does not address laser thermal therapy or laser ablation as treatment in breast cancer.

 

American Society of Clinical Oncology (ASCO)

ASCO clinical guidelines do not address laser thermal therapy as treatment in tumors of the genitourinary system, head and neck, breast, bone, or in neurooncology.

 

Congress of Neurological Surgeons

In 2019, the Congress of Neurological Surgeons issued a systematic review and evidence-based guideline on the role of emerging and investigational therapies for the treatment of adults with metastatic brain tumors that included the following recommendation:

  • Laser Interstitial Thermal Therapy
    • There is insufficient evidence to make a recommendation regarding the routine use of laser interstitial thermal therapy (LITT), aside from use as part of approved clinical trials.

 

American Society of Breast Surgeons

In 2018, the American Society of Breast Surgeons issued a consensus guideline on the use of transcutaneous and percutaneous ablation for the treatment of benign and malignant tumors of the breast that included the following:

 

Summary on Data Reviewed

  • Indications for percutaneous or transcutaneous ablative treatment of malignant tumors of the breast: At this time, there are no FDA approved percutaneous or transcutaneous ablative treatments for breast cancer. At the present time, cryoablation is approved for treatment of soft tissue malignancies. However, there is emerging data from clinical trials utilizing percutaneous ablative therapies for patients with early stage breast cancer without surgical excision. Techniques being evaluated include ablation by focused ultrasound, laser, cryotherapy, microwave, and radiofrequency. Percutaneous excision by vacuum-assistance is also being investigated

 

Recommendation
  • Cryoablation is currently approved for treatment of benign and malignant soft tissue tumors by the FDA. Currently, there are no specific technologies that have FDA approval for breast tumors. Participation in registries and clinical trials evaluating the use of these technologies with and without surgical excision of a breast malignancy is advised as early data emerges on their efficacy.

 

American Academy of Orthopaedic Surgeons (AAOS)

The AAOS does not endorse laser interstitial thermal therapy (LITT) for treatment of osteoid osteoma.

 

Regulatory Status

Laser interstitial thermal therapy (LITT) is a procedure and, therefore, not subject to FDA regulation.

 

The NeuroBlate® System (Monteris Medical, MN) enables MRI-guided neurosurgical ablation, monitoring 3-D and providing real time imaging to support a surgeon’s clinical decision matrix. The device was FDA approved on October 26, 2016.

 

The Visualase® Thermal Therapy System (Medtronic, MN) provides advanced MRI-guided laser ablation technology for thermal ablation markets, including neurosurgery. Delivery of laser energy results in rising temperatures in the target area, destroying the unwanted tissue. The device was FDA approved on September 10, 2008.

 

On 04/25/2018, the FDA issued an FDA Alert on MR-Guided Laser Interstitial Thermal Therapy Devices with a letter to providers stating the FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. “For example, MR parameters such as voxel size (measurement of the image resolution or detail) and MR image acquisition time (e.g., up to 8 seconds) may contribute to inaccurate MR thermometry readings and potential errors in the ablation assessment. In addition, MRgLITT devices may not account for the continued thermal spread of energy to the surrounding tissue (as the target ablation area returns to its baseline temperature), which may result in an underestimation of thermal damage.”

 

Prior Approval:

Not applicable.

 

Policy:

See Related Medical Policies

  • 04.01.09 MRI-Guided High-Intensity Focused Ultrasound (MRGFUS) Ablation 
  • 02.01.53 High Intensity Focused Ultrasound (HIFU)
  • 07.01.69 Treating Benign Prostatic Hyperplasia

 

The treatment of medically refractory epilepsy using MRI-guided laser interstitial thermal therapy (MRIgLITT) is considered medically necessary when ALL of the following criteria are met:

  • Documented disabling seizures despite the use of two or more tolerated antiepileptic drug regiments; and 
  • Documented (i.e. imaging or EEG) presence of well-defined epileptogenic foci accessible by laser interstitial thermal therapy (LITT).

 

MRI-guided laser interstitial thermal therapy (MRIgLITT) when the above criteria is not met and for all other indications, including but not limited to the following is considered investigational because the evidence is insufficient to determine the effects of the technology on health outcomes:

  • Epilepsy except as indicated above
  • Brain tumors (primary and metastatic)
  • Breast cancer (benign or malignant)
  • Liver cancer (primary and metastatic)
  • Lung cancer (primary and metastatic)
  • Osteoid osteoma
  • Prostate cancer
  • Radiation necrosis 

 

Policy Guidelines

Medically refractory epilepsy: Occurs when an individual has failed to become seizure free with adequate trials of two seizure medications (called AEDs). These seizure medications must have been chosen appropriately for the individual’s seizure type, tolerated by the individual, and tried alone or together with other seizure medications.

 

Epileptogenic lesion: Is defined as the structural abnormality that is presumed be the basis of the seizure(s).

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD diagnosis codes.

  • 19499 Unlisted procedure, breast
  • 20999 Unlisted procedure, musculoskeletal system, general
  • 27599 Unlisted procedure, femur or knee
  • 32999 Unlisted procedure, lungs and pleura
  • 47399 Unlisted procedure, liver
  • 55899 Unlisted procedure, male genital system
  • 60699 Unlisted procedure, endocrine system
  • 64999 Unlisted procedure, nervous system

 

Selected References:

  • Grewal, SS, Alvi, MA, Lu, VM, Wahood, W, Worrell, GA, Tatum, W, Wharen, RE, Jr., and Van Gompel, JJ. Magnetic Resonance-Guided Laser Interstitial Thermal Therapy Versus Stereotactic Radiosurgery for Medically Intractable Temporal Lobe Epilepsy: A Systematic Review and Meta-Analysis of Seizure Outcomes and Complications. World Neurosurg. 2019;122:e32-e47
  • Hoppe, C, and Helmstaedter, C. Laser interstitial thermotherapy (LiTT) in pediatric epilepsy surgery. Seizure. 2018
  • Xue, F, Chen, T, and Sun, H. Postoperative Outcomes of Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in the Treatment of Drug-Resistant Epilepsy: A Meta-Analysis. Med Sci Monit. 2018;24:9292-9299
  • Hale, AT, Sen, S, Haider, AS, Perkins, FF, Clarke, DF, Lee, MR, and Tomycz, LD. Open Resection vs Laser Interstitial Thermal Therapy for the Treatment of Pediatric Insular Epilepsy. Neurosurgery. 2019
  • Petito, GT, Wharen, RE, Feyissa, AM, Grewal, SS, Lucas, JA, and Tatum, WO. The impact of stereotactic laser ablation at a typical epilepsy center. Epilepsy Behav. 2018;78:37
  • Lam, S, Hadley, C, Curry, DJ, and Pan, IW. Comparison of Perioperative Costs between Stereotactic Laser Ablation and Craniotomy for Hypothalamic Hamartoma. Journal of Pediatric Epilepsy. 2017;6(2):97-102
  • Drane, DL, Loring, DW, Voets, NL, Price, M, Ojemann, JG, Willie, JT, Saindane, AM, Phatak, V, et al. Better object recognition and naming outcome with MRI-guided stereotactic laser amygdalohippocampotomy for temporal lobe epilepsy. Epilepsia. 2015;56(1):101-113
  • Wu, C, Jermakowicz, WJ, Chakravorti, S, Cajigas, I, Sharan, AD, Jagid, JR, Matias, CM, Sperling, MR, et al. Effects of surgical targeting in laser interstitial thermal therapy for mesial temporal lobe epilepsy: A multicenter study of 234 patients. Epilepsia. 2019;60(6):1171-1183
  • Boerwinkle, VL, Foldes, ST, Torrisi, SJ, Temkit, H, Gaillard, WD, Kerrigan, JF, Desai, VR, Raskin, JS, et al. Subcentimeter epilepsy surgery targets by resting state functional magnetic resonance imaging can improve outcomes in hypothalamic hamartoma. Epilepsia. 2018;59(12):2284-2295
  • Rennert, RC, Khan, U, Bartek, J, Jr., Tatter, SB, Field, M, Toyota, B, Fecci, PE, Judy, K, et al. Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. 2019
  • Lagman, C, Chung, LK, Pelargos, PE, Ung, N, Bui, TT, Lee, SJ, Voth, BL, and Yang, I. Laser neurosurgery: A systematic analysis of magnetic resonance-guided laser interstitial thermal therapies. J Clin Neurosci. 2017;36:20-26
  • Kang JY and Sperling MR. Epileptologist’s view: Laser interstitial thermal ablation for treatment of temporal lobe epilepsy. Epilepsy Res. 2018 Nat; 142:149-152
  • American Academy of Orthopaedic Surgeons (AAOS) website. OrthoInfo, Osteoid Osteoma.
  • American Society of Breast Surgeons (ASBrS). Consensus Guideline on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast. October 2018. 
  • American Society of Clinical Oncology (ASCO) website. Guidelines, Tools, and Resources
  • National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 3.2020. 
  • National Comprehensive Cancer Network (NCCN) Central Nervous System Cancers Version 3.2020
  • National Comprehensive Cancer Network (NCCN) Bone Cancer Version 1.2021. 
  • National Comprehensive Cancer Network (NCCN) Non-Small Cell Lung Cancer Version 1.2021.
  • National Comprehensive Cancer Network (NCCN) Small Cell Lung Cancer Version 1.2021.
  • National Comprehensive Cancer Network (NCCN) Hepatobiliary Cancers Version 5.2020.
  • National Comprehensive Cancer Network (NCCN) Breast Cancer Version 6.2020. 
  • ECRI Institute. Laser Interstitial Thermal Therapy for Breast Cancer. Plymouth Meeting (PA): ECRI Institute; 2019 Jan 14. (Custom Rapid Responses)
  • ECRI Institute. Laser Interstitial Thermal Therapy for Nonglioblastoma Brain Cancers. Plymouth Meeting (PA): ECRI Institute; 2019 Jan 14. (Custom Rapid Responses)
  • ECRI Institute. Laser Interstitial Thermal Therapy for Epilepsy. Plymouth Meeting (PA): ECRI Institute; 2019 Sept 10. (Custom Rapid Responses)
  • ECRI Institute. Laser Interstitial Thermal Therapy for Osteoid Osteoma. Plymouth Meeting (PA): ECRI Institute; 2019 Jan 11. (Custom Rapid Responses)
  • ECRI Institute. Laser Interstitial Thermal Therapy for Treating Glioblastoma. Plymouth Meeting (PA): ECRI Institute; 2019 Jan 08. (Custom Rapid Responses)
  • ECRI Institute. Laser Interstitial Thermal Therapy for Localized Prostate Cancer. Plymouth Meeting (PA): ECRI Institute; 2019 Jan 07. (Custom Rapid Responses)
  • ECRI Institute. Laser Interstitial Thermal Therapy for Lung Cancer Published January 14, 2019 (Custom Rapid Responses)
  • ECRI Institute. Laser Interstitial Thermal Therapy for Metastases to the Liver Published January 14, 2019 (Custom Rapid Responses)
  • UpToDate. Overview of the Treatment of Brain Metastases. Jay S. Loeffler M.D., Topic last updated October 15, 2020. 
  • UpToDate. Management of Recurrent High-Grade Gliomas. Tracy Batchelor M.D., MPH, Helen A. Shih M.D., MS, MPH, Bob S. Carter M.D. PhD. Topic last updated June 25, 2020. 
  • UpToDate. Nonsurgical Therapies for Localized Hepatocellular Carcinoma: Radiofrequency Ablation, Laser and Microwave Thermal Ablation, Percutaneous Injection Therapies, Cyroablation, High-Intensity Focused Ultrasound and Irreversible Electroporation. Steve A. Curley M.D., FACs, Keith E. Stuart M.D., Jonathan M. Schwartz M.D., Robert L. Carithers Jr, M.D., Topic last updated March 26, 2020. 
  • UpToDate. Delayed Complications of Cranial Irradiation. Jorg Dietrich M.D., PhD, Viani Gondi M.D., Minesh Mehta M.D., Topic last updated September 11, 2020. 
  • UpToDate. Image-Guided Ablation of Skeletal Metastases. Anil Nicholas Kurup M.D., Matthew R. Callstrom M.D., PhD. Topic last updated May 19, 2020. 
  • UpToDate. Nonmalignant Bone Lesions in Children and Adolescents. John E. Tis M.D., Topic last updated March 26, 2020
  • Faure Walker, NA, Norris, JM, Shah, TT, Yap, T, Cathcart, P, Moore, CM, Ahmed, HU, Emberton, M, et al. A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review. Urol Oncol. 2018;36(2):67-76 
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Policy History:

  • December 2020, New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

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