(NOTE: This policy only applies to adult members. It does not apply to pediatric members.

All cases will require review of the consultation note and the most recent positron emission tomography (PET) scan (demonstrating no evidence of widespread metastatic disease).

For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

1. Stereotactic Body Radiotherapy (SBRT) for extra-cranial oligometastases is medically necessary in the following clinical situations:
   1. For an individual with non-small cell lung cancer who:
      1. Has had or who will undergo curative treatment of the primary tumor (based on T and N stage), and
      2. Has 1 to 3 metastases in the synchronous setting
   2. For an individual with colorectal cancer who:
      1. Has had or who will undergo curative treatment of the primary tumor, and
      2. Presents with 1 to 3 metastases in the lung or liver in the synchronous setting, and
      3. For whom surgical resection is not possible
   3. For an individual with:
      1. A clinical presentation of one 1 to 3 adrenal gland, lung, liver or bone metastases in the metachronous setting when all the following criteria are met:
         1. Histology is non-small cell lung, colorectal, breast, sarcoma, renal cell, or melanoma
         2. Disease free interval of >1 year from the initial diagnosis
         3. Primary tumor received curative therapy and is controlled
         4. No prior evidence of metastatic disease (cranial or extracranial)
2. SBRT used to stimulate the abscopal effect is considered investigational.
3. SBRT as a complete course of therapy must be completed in five fractions.

A. Oligometastatic

1. A malignancy that has progressed to 1 to 3 hematogenous metastatic sites

B. Synchronous Oligometastasis

1. Oligometastatic disease found at the time of the diagnosis of the primary tumor

C. Metachronous Oligometastasis

1. Oligometastatic disease found after treatment of the primary tumor

D. Oligoprogression

1. Progression of a limited number of metastatic sites while other metastatic disease sites remain controlled. SBRT is not medically necessary in an individual with oligoprogressive disease.

Oligometastases is described as an intermediate state in the spread of cancer between early-stage localized disease and widespread metastases. Specifically, it is a malignancy that has progressed to a limited number of hematogenous metastatic sites, defined in most studies as 1 to 3 sites. Chemotherapy remains the standard of care for patients with metastatic cancer, however this is rarely curative. The concept of oligometastases has important implications for cancer treatment because it is believed that patients with limited numbers of metastasis previously thought by some clinicians to be incurable may be cured with local treatments such as radiotherapy.

The data supporting the treatment of extracranial oligometastases is largely limited to single institution studies, registry studies or limited phase II randomized studies. Some of the retrospective studies have demonstrated improved outcomes compared to historical controls. There is no level one phase III evidence demonstrating a clear benefit to treatment of extracranial oligometastastes. The data with the longest follow-up is the surgical literature examining the resection of non-small cell lung and hepatic metastases. The International Registry of Lung Metastases examined 5,206 patients between 1945 and 1995 at 18 institutions and found 36% survival at 5 years (Pastorino et al., 1997). Patients with the best prognosis were those with a single resectable metastasis with a disease free interval > 3 years. In metastatic colorectal cancer to the liver, hepatic resection has resulted in a 5-year survival of 28% in a well-selected population (Nordlinger et al., 1996). Similar outcomes have been demonstrated in adrenal metastectomy for non-small cell lung cancer and pulmonary metastatectomy for osteosarcoma in children (Kager et al., 2003; Tanvetyanon, et al., 2008).

SBRT offers ablative doses delivered with greater precision to a limited target volume than previous radiation delivery technologies. There have been several phase I/II studies which have demonstrated the technical feasibility of delivering SBRT for patients with non-small cell lung, liver and spine metastases (Lee et al., 2009; Milano et al., 2012; Rusthoven, et al., 2009; Salama et al., 2012; Wang et al., 2012). Furthermore, there have been several reports documenting the efficacy of SBRT or hypofractionated radiation in various different histologies including non-small cell lung, breast, colon, renal, melanoma, and sarcoma (Hasselle, et al., 2012; Hoyer, et al., 2006; Milano, et al., 2009; Ranck et al., 2013). These studies have used anywhere from 3 to 10 fractions across a range of total doses. All have demonstrated local control of the treated lesions from 70 to 90%.

The major limitation of these previous studies is that they have been single arm, non-controlled, with small patient numbers and often limited to single institutions. Furthermore, they are subject to “immortal” time bias that artificially inflates the survival of patients who underwent metastatectomy compared to those who did not. Patients included in these studies are highly selected, based on good performance status and slow pace of tumor progression. Therefore, the long-term survival achieved in these studies of treatment of oligometastases may be the result of the selection of fit patients with very slow-growing tumors rather than the result of treatment intervention. Also, the endpoints chosen or reported in these studies, such as progression free survival, interval until next systemic therapy, or local control of metastases, may not prove to be clinically relevant long term benefits. Therefore, none of these reports offers definitive clinical evidence that overall outcomes are improved with metastases directed SBRT compared to best standard therapies.

Palma et al (2019) published the results of the SABR-COMET (Stereotactic Ablative Radiation Therapy for the Comprehensive Treatment of Oligometastatic Tumors) trial. This randomized phase II trial included patients with controlled primary site and up to 5 sites of hematogenous metastasis. Inclusion criteria required histologically confirmed malignancy (of the primary or metastatic site), ECOG status 0-1, at least 3 month interval since definitive treatment of primary without recurrence, maximum of 3 metastases in any one organ system, not a candidate for surgical resection at all sites, and no concurrent chemotherapy. Some important exclusions were patients with brain metastases with no disease elsewhere, malignant pleural effusion, prior radiation to a treatment site, spinal cord compression or disease within 3 mm of the spinal cord. Patients with previously treated or resected metastases were eligible if there was no evidence of recurrence at that site on imaging. This trial was designed as a randomized phase II “screening” trial to determine possible evidence of efficacy. Additionally, this trial was designed to allow for more modest patient accrual numbers and to provide an initial, non-definitive comparison between the two arms. Therefore, the study used 0.20 as the two-sided p value for significance as opposed to the traditional p value of 0.05. Ninety-nine patients were accrued to the study between February 2012 and August 2016. 66 patients were randomized to the SABR group and 33 patients were randomized to the control group. The study was interpreted as positive with median survival in the SABR arm of 41 months compared to 28 months for the control arm (p=0.09).

Although the results of the SABR-COMET trial add significantly to the knowledge base for this clinical setting, there are several important limitations and observations about the study. The chosen alpha for significance of 0.20 is not the traditionally accepted level of a statistically significant difference (0.05). It is important to note that the study investigators qualify the results of this screening study as initial and non-definitive. In addition, while the study inclusion criteria specified that the primary tumor must have been treated definitively at least 3 months before enrollment with no progression, the median time from diagnosis of primary tumor to randomization was 2.3 years (1.3-4.5 years) in the control group and 2.4 years (1.6-5.3 years) in the SABR group (Loo & Diehn, 2019). This suggests that the patients selected for inclusion in the study with metachronous oligometastases had a more favorable biology and were likely to have better overall prognosis. Furthermore, the study included patients from a broad spectrum of histologies including but not limited to metastatic breast, lung, colorectal, and prostate cancer. Diagnosis specific randomized control trials are needed to provide strong evidence of the benefit of SABR. Prostate cancer comprised 21% of the SABR arm but only 6% of the control arm patients which may skew results considering the long natural history and hormone-sensitivity of prostate cancer. Only 18 patients enrolled in the trial had lung cancer. Additionally, almost all patients in the study has 1-3 metastases. There were only 7 patients with 4-5 metastatic sites and no control arm patients with 5 sites, so data in that group is very limited and unreliable. It should be noted that Grade >2 toxicity was significantly higher in the SABR arm (29% vs. 9%, p=.03), and there were 3 deaths in the SABR arm attributed to treatment (4.5%) with none in the control arm. At the time of progression, patients in the SABR arm were eligible for further SABR treatment, while patients in the control arm were eligible only for palliative dose radiation. As noted in the associated editorial by Loo and Diehn (2019), “before broad adoption, a positive overall survival outcome in a phase 2 screening trial mandates support from definitive phase 3 studies, ideally in each primary tumour type.” Ongoing prospective, randomized disease specific trials are needed to define the benefit of SBRT in this population. Considering the limitations of this study, SBRT for treatment of patients with >3 metastases and less than 1 year disease free interval from time of definitive therapy is not supported at this time and is not medically necessary.

Selection of an appropriate individual is imperative when deciding who is eligible to receive SBRT in the oligometastatic setting. One study revealed a 40% progression rate within 3 months of SBRT for 1 to 5 metastases and 80% progression at 2 years, which emphasizes the fact that the vast majority of patients have micro-metastatic disease at time of treatment (Milano, et al., 2012). Furthermore, disease free survival (DFS) after SBRT is associated with time to recurrence after initial diagnosis. One analysis found 3-year survival after SBRT was 53% for patients with a disease free interval of more than 12 months vs. 19% for patients with a disease free interval of less than 12 months (Inoue, et al., 2010). Another analysis found a disease free interval of more than 12 months was also associated with improved outcomes following treatment with SBRT for oligometastatic disease (Zhang, et al., 2011).

A. Non-small cell lung


There is a population of individuals with non-small cell lung cancer presenting with oligometastatic disease that will benefit from metastases-directed ablative procedures. A recent retrospective analysis of patients with oligometastatic non-small cell lung cancer who underwent metastasis directed treatment (intra and extra cranial) found a 2-year survival of 38% (Griffioen, et al., 2013). A recent review of the literature found that while the majority of patient’s progress within 12 months, there is a subset of long-term survivors (Ashworth et al., 2013). Ashworth and colleagues (2013) performed a systematic review of 49 studies including 2,176 patients with one to five metastases from NSCLC who underwent surgery or radiation. 82% of patients had controlled primary disease, and 60% of studies were limited to intracranial metastasis. Median survival was 14.8 months, median time to progression was 12 months, and median 5-year overall survival (OS) was 23.3%. Control of primary disease, N stage, and disease-free interval of at least 6 to 12 months prior to diagnosis of oligometastases were found to be prognostic on multivariable analysis.

Iyengar et al (2018) reported early results of a single institution phase II randomized study of SBRT for patients with biopsy-proven metastatic non-small cell lung cancer with stable or responsive disease after initial chemotherapy in 29 patients (14 treated with SBRT). Patient were randomized to chemotherapy alone for the control arm or to receive SBRT to up to 5 metastatic lesions plus the lung primary followed by maintenance chemotherapy. The study showed significant (p=0.01) reduction in progression free survival for the SBRT arm, with most progressive disease in areas of original disease in the control arm while progression in untreated areas was the only site of progression in the SBRT arm. A statistically significant OS benefit was not noted. Use of progression free survival as a primary endpoint has been criticized and improved PFS may not translate into meaningful survival benefit in such patients.

Gomez et al (2019) reported a multicenter, randomized, phase II trial of patients with Stage IV NSCLC with treatment for 3 or fewer metastases who had not progressed on first line chemotherapy. Patients (n=49) were randomized to local therapy (surgery, SBRT or hypofractionated radiation, some with concurrent chemotherapy) to all disease sites or maintenance chemotherapy/observation. The results showed a median overall survival of 17.0 months with maintenance/observation compared to 41.2 months for the treated arm (p=.017). Potential confounding issues included that patients in either arm could get SBRT/surgery at the time of progression so there was crossover permitted. Subgroup analysis showed that the only group with significant survival advantage were those with 0-1 metastases after initial chemotherapy, and those with 2-3 metastases had no improvement in survival.

SBRT is considered medically necessary in an individual with non-small cell lung cancer who presents in the synchronous or metachronous setting, has 1 to 3 sites of disease, and good performance status, assuming SBRT can be delivered safely to the involved sites.


B. Colon

Surgical series have shown that selected patients with colorectal cancer undergoing resection of hepatic and/or pulmonary metastases results in a cure for a proportion of patients with a 5-year survival of 38% (Kanas et al., 2012). The European Organisation for Research and Treatment of Cancer (EORTC) conducted the only randomized phase II study in the oligometastatic setting where patients with liver metastases from colon cancer were randomized to radiofrequency ablation plus chemotherapy or chemotherapy alone (Ruers et al., 2017). The 5 year overall survival was 43% in the radiofrequency ablation arm and 30% in the control arm (p = 0.01), with median follow up of 9.7 years.

SBRT is considered medically necessary in an individual with colorectal cancer who presents in the synchronous or metachronous setting, has 1 to 3 sites of disease limited to the lung or liver, and good performance status, assuming surgical resection is not feasible.


C. Breast

An analysis of breast cancer patients who underwent treatment with SBRT for oligometastatic disease compared outcomes to other histologies. Patients who underwent SBRT for oligometastatic breast cancer had a progression free survival (PFS) at 2 years of 36% vs. 13% for non-breast histology, and overall survival (OS) at 6 years was 47% vs. 9% for non-breast histology. A review of literature by Kucharczyk et al (2017) identified 41 studies of treatment for oligometastasis from breast primary. All studies were observational cohort studies (level 2B or 4 evidence). The authors concluded that existing evidence does not provide meaningful direction on which metastatic breast cancer patients should have ablation of their residual disease due to heterogeneous reporting of disease factors, patient factors, and outcomes.

SBRT is considered medically necessary in an individual with breast cancer who presents in the metachronous setting; has 1 to 3 sites of disease limited to the lung, liver, or bone, has a disease free interval of > 1 year; and received curative therapy to the primary tumor.


D. Sarcoma, renal, melanoma

A retrospective analysis examining pulmonary metastases from sarcoma found those who received local ablative treatment to have improved median survival of 45 months vs. 12 months for those who had no local therapy to the metastases (Falk, et al., 2015). Previous retrospective literature has demonstrated a survival benefit for patients with metastatic sarcoma who underwent a pulmonary metastasectomy (van Geel, et al., 1996). Pulmonary resection for renal cell cancer is associated with a 5-year survival of 20% (Murthy, et al., 2006). In the setting of melanoma there have also been retrospective studies demonstrating a benefit to lung resection of metastases. An analysis of melanoma in the international registry of lung metastasis found a 5-year survival of 22% after complete metastasectomy.

Based on this data, SBRT is considered medically necessary in an individual with sarcoma, renal, or melanoma metastases who meets the following criteria: 1-3 metastases, disease free interval of > 1 year from the initial diagnosis, primary tumor received curative therapy and is controlled, and no prior evidence of metastatic disease.


E. Prostate Cancer

There is limited comparative data regarding the use of SBRT for prostate cancer metastases. In the STOMP trial, Ost et al (2018) reported a trial of 62 patients randomized in a phase II study to SBRT to metastatic sites of recurrence after prior definitive treatment to the primary. Patients were diagnosed when there was PSA recurrence and choline PET scan showed ≤3 lesions. The primary endpoint was androgen deprivation therapy (ADT) free survival. There was a trend towards improved ADT- free survival in the metastasis directed therapy group compared to the surveillance group (21 months vs 13 months, p=0.11). However, there was no difference in quality of life at 3 months and 1 year follow-up. While the study found that there was prolongation of ADT initiation in the SBRT arm, this endpoint has been criticized as a measure of efficacy. Additionally, progression of untreated metastases before the treated metastases would be expected, which led to earlier initiation of ADT. This is not clearly a clinically meaningful benefit and is not equivalent to a survival benefit. Another criticism is that the control arm was observation but standard treatment for metastatic disease is ADT, which was initially withheld from both cohorts. Furthermore, while this study demonstrated that metastases directed therapy may lead to a delay in initiation of androgen deprivation therapy, there was no statistically significant difference in quality of life at 3 month follow-up or 1 year follow-up.

The American Society of Clinical Oncology published the “Approach to Oligometastatic Prostate Cancer” (Bernard et al, 2018). In this article, the authors note that the role for radiation therapy as a solitary therapy or in combination with systemic therapy for oligometastatic prostate cancer is “evolving” but “unproven.” There are multiple ongoing clinical trials that have been designed to determine the role of radiation therapy for oligometastatic prostate cancer.

Due to the long natural history of prostate cancer progression, the sensitivity of prostate cancer to androgen deprivation therapy and other endocrine treatments, and lack of high quality evidence to suggest that ablative therapies for metastatic disease improve survival, SBRT for treatment of metastases from prostate cancer is not medically necessary.


F. Treatment of > 3 sites or nonhematogenous sites

There is limited data on the survival benefit of treating multiple metastases (> 3 metastases). Surgical studies have suggested that tumor burden is predictive of overall survival. In the surgical literature, the number and size of metastatic lesions (> 3 hepatic metastases, hepatic metastases ≥ 5 cm, > 1 lung metastasis), extrahepatic spread, poorly differentiated disease, positive resection margins, and a short disease free interval (< 36 months) have been independent predictors for poor survival. Salama et al. (2012) reported a longer progression free survival (PFS) in patients with 1–3 metastatic sites versus those with 4–5 metastases receiving escalating SBRT doses to all sites of disease. The toxicity of using SBRT for treating multiple metastases (> 3 metastases) can be potentially significant. As demonstrated in the SABR-COMET trial, Grade > 2 toxicity was significantly higher in the SABR arm (29% vs 9%, p=.03), and there were 3 deaths in the SABR arm attributed to treatment (4.5%) with none in the control arm. In light of this, the Radiation Therapy Oncology Group (RTOG) is currently conducting a phase I study examining the safety of SBRT for the treatment of multiple metastases. Furthermore, SABR-COMET 10 is an ongoing randomized Phase III trial evaluating SBRT in the treatment of 4 -10 metastases.

Based on these ongoing studies, the limitation in the number of metastases treated in most reports, and the lack of evidence of a clinically significant benefit for treatment of larger number of metastases in the limited randomized literature, SBRT to > 3 sites is considered not medically necessary. Furthermore, the current medical literature has primarily only examined the use of SBRT in patients with hematogenous spread (lung, liver, bone). Therefore, the use of SBRT to non-hematogenous sites of spread such as lymphatic regions is considered not medically necessary.


G. Oligoprogression

Oligoprogression is the clinical scenario where there is progression of a limited number of metastatic sites while other metastatic disease sites remain controlled. The other metastatic sites remain stable or are responding to systemic therapy while a few areas of metastatic disease progress (Cheung, 2016). There is limited published data on oligoprogression and most of the data on oligoprogression is focused on patients with nonsmall cell lung cancer while on targeted therapy (Cheung, 2016). Some studies have suggested that patient with actionable mutations in non-small cell lung cancer may derive a greater benefit from receiving SBRT or hypofractionated radiotherapy for oligoprogressive disease (Gan, et al., 2014; Iyengar, et al., 2014). Due to the limited number of patients included in these analyses, it is difficult to make definitive conclusions regarding the benefit of SBRT for oligoprogressive disease for patients with actionable mutations. There are ongoing trials to evaluate the use of SBRT for this population, such as the HALT trial in the UK and STOP-NSCLC in Canada (Cheung, 2016). Therefore, as there is limited information on the use of SBRT in patients with oligoprogression, SBRT is considered not medically necessary for an individual with oligoprogressive disease.

H. Summary

There is intense interest in the potential use of focal ablative radiation, and there are several ongoing or planned randomized trials to evaluate such treatment. At this time, the results of large well-designed randomized trials with mature follow up data are not available. Further information from such trials will assist with determining the proper place for such therapy in the future. Based on the current available data, the use of SBRT outside of the parameters of this policy is considered not medically necessary. Current ongoing randomized trials include: NRG LU002, NRG BR002, SABR-COMET-10, ORIOLE (Prostate) and trials for oligoprogression: STOP (NCT02756793), HALT (NCT03256981).]

2. ASTRO Radiation Oncology Coding Resource

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*