Surgery Section - Radiofrequency Ablation of Tumors (RFA)

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Radiofrequency ablation (RFA) can be used to treat inoperable tumors or to treat patients ineligible for surgery due to age, presence of comorbidities, or poor general health. Goal(s) of RFA may include 1) controlling local tumor growth and preventing recurrence; 2) palliating symptoms; and 3) extending survival duration for patients with certain tumors. The procedure kills cells (cancerous and normal) by applying a heat-generating rapidly alternating current through probes inserted into the tumor. The effective volume of RFA depends on the frequency and duration of applied current, local tissue characteristics, and probe configuration (e.g., single versus multiple tips). RFA can be performed as an open surgical procedure, laparoscopically, or percutaneously with ultrasound or computed tomography (CT) guidance.

Potential complications associated with RFA include those caused by heat damage to normal tissue adjacent to the tumor (e.g., intestinal damage during RFA of kidney), structural damage along the probe track (e.g., pneumothorax as a consequence of procedures on the lung), or secondary tumors if cells seed during probe removal.

RFA was developed initially to treat inoperable tumors of the liver. Recently, reports have been published on use of RFA to treat renal cell carcinomas, breast cancer, pulmonary (primary lung cancers or metastatic tumors), bone, and other tumors. For some of these, RFA is being investigated as an alternative to surgery for operable tumors. Well-established local or systemic treatment alternatives are available for each of these malignancies. The hypothesized advantages of RFA for these cancers include improved local control and those common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).

Liver Tumors

The liver is a frequent site of neoplastic disease. Options for treatment of liver tumors, whether primary or metastatic, are limited. The gold standard for treatment remains surgical resection, but due to the extent of disease or presence of disease beyond the liver, 80% of liver tumors are not amenable to surgery at the time of diagnosis. Radiofrequency thermal ablation of ultrasonically mapped liver tumors appears to offer patients a minimally invasive treatment for local control of liver tumors.

Renal Cell Carcinoma

Localized renal cell carcinoma (RCC) is treated by radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule, since chemotherapy is relatively ineffective against metastatic RCC.

Breast Tumors

Early-stage primary breast tumors are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach balances the patient’s desire for breast conservation, the need for tumor-free margins in resected tissue, and the patient’s age, hormone receptor status, and other factors. Adjuvant radiation therapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/ or chemotherapy are added, depending on presence and number of involved nodes, hormone receptor status, and other factors. Fibroadenomas are benign tumors of the breast, which may present as a palpable mass or a mammographic abnormality. Fibroadenomas are typically surgically excised.

Pulmonary Tumors

Primary lung cancers are resected if they are small, solitary masses. Adjuvant radiation and chemotherapy usually are added, most often using a platinum compound combined with one or more other drugs such as a taxane, alkylating agent, vinca alkaloid, or topoisomerase inhibitor. The preferred regimen depends on histologic type. Patients with metastatic pulmonary lesions are also treated with chemotherapy, but with palliative intent or to relieve symptoms.

Surgical resection of isolated metastatic lung lesions is an option, but is not used very often due to generally poor patient health, inoperability of most metastatic lesions, and lack of evidence for benefit to patients.

Osteoid Osteomas

Osteomas are benign tumors of the bone typically seen in children and young adults. They cause inflammation, local effects on normal tissue from tumor expansion, and secondary effects and complications (e.g., scoliosis, osteoarthritis). Open excision is the accepted treatment and is generally successful. However, it is associated with increased risk of fracture, recurrence of larger tumors, and incomplete resection of anatomically inaccessible tumors.

Bone Metastases

After lung and liver, bone is the third most common metastatic site and is relatively frequent among patients with primary malignancies of the breast, prostate, and lung. Bone metastases often cause osteolysis (bone breakdown), resulting in pain, fractures, decreased mobility, and reduced quality of life. External beam irradiation often is the initial palliative therapy for osteolytic bone metastases. However, pain from bone metastases is refractory to radiation therapy in 20% to 30% of patients, while recurrent pain at previously irradiated sites may be ineligible for additional radiation due to risks of normal tissue damage. Other alternatives include hormonal therapy, radiopharmaceuticals such as strontium-89, and bisphosphonates. Less often, surgery or chemotherapy may be used for palliation and intractable pain may require opioid medications. RFA has been investigated as another alternative for palliating pain from bone metastases.

Policy/Criteria

1. Radiofrequency ablation may be considered medically necessary for treatment of the following:


1. Osteoid osteomas
2. Primary liver tumors
3. To palliate pain in patients with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids
2. Radiofrequency ablation is considered investigational as a technique for ablating all other tumors including but not limited to:


1. Adrenal cancer
2. Breast cancer
3. Breast fibroadenomas
4. Chordomas
5. Head and neck cancer
6. Initial treatment of painful bony metastases
7. Lymphoma
8. Metastases to the liver from other organ tumors
9. Ovarian cancer
10. Pelvic/abdominal metastases of unspecified origin
11. Renal cell carcinoma
12. Tumors of the lung

Position Summary

Liver Tumors

This policy for liver tumors is based, in part, on a 2003 TEC Assessment that offered the following observations and conclusions regarding various applications of radiofrequency ablation (RFA): (3)

• For patients with unresectable hepatocellular carcinoma, the data was considered insufficient to permit firm conclusions. Specifically, the follow up data in the nine reported studies was short (less than 12 months in seven of nine studies) such that adequate comparisons could not be made to other treatment options, such as percutaneous ethanol infusion.
• Similarly, there was insufficient data regarding the use of radiofrequency ablation combined with another therapy (i.e., resection) in the treatment of patients with hepatocellular carcinoma.
• In patients with hepatic metastasis, there was insufficient data to permit conclusions. The results appear no better than results reported after neoadjuvant therapy. However, survival estimates for either therapy are based on small samples without direct comparison of the interventions.
• Similarly, there was insufficient adequate data regarding the use of radiofrequency ablation combined with another therapy (i.e., resection) in the treatment of patients with hepatic metastases.

Subsequent updated searches of the literature have revealed several new published nonrandomized studies of RFA in the treatment of primarily unresectable hepatocellular carcinoma and liver metastatic disease. (3-9) These series report 66% to 90% complete necrosis of the target liver lesion. Failure of complete necrosis occurred almost exclusively in tumors over seven cm in size. Median follow-up of all patients was 8.8 months. During this time local recurrence was minimal. Despite good local control, many patients experienced recurrence at new sites within the liver. Based on the relatively high recurrence rate RFA is generally combined with either surgical resection, if possible, or a regional therapy such as intraarterial infusion or chemoembolization.

Despite the lack of randomized clinical trials and long term outcomes for radiofrequency ablation of liver tumors, the policy considers that medical necessity may be established due to the lack of well-researched alternatives and clearly defined standard therapies.

An updated search identified approximately 50 publications discussing application of RFA to primary and metastatic tumors other than the liver. Except for one study, (50) a retrospective comparison of two consecutive series of osteoma patients treated with RFA or open excision, the identified studies were uncontrolled, retrospective case series or case reports. Furthermore the reviewed studies generally reported only immediate or short-term effects of RFA that did not permit conclusions regarding the net health benefit of RFA for patients with these tumors. The following sections summarize the evidence for those applications of RFA with evidence available from at least one case series.

Renal Cell Carcinoma

The outcomes of RFA procedures in more than 550 patients with a total of nearly 700 lesions have been described in 21 uncontrolled studies. (10-30)  The characteristics of the patients and RFA procedures varied widely within and across the studies in terms of tumor type (e.g., exophytic, parenchymal, central, with or without history of von Hipple-Lindau disease), tumor size (from <1 cm to 8 cm), length of follow-up (from <1 month to 48 months), imaging modality used for guidance, and reason for using RFA. Overall, 88%-100% of procedures were considered successful shortly after one or two ablations (i.e., no signs of residual tumor by histologic analysis after excision or by post-RFA radiologic imaging). Significant but nonfatal complications were reported in 8%–13% of patients in seven studies, including perinephric hematomas, hemorrhage, and ureteral strictures.

In general, available data were inadequate or lacked appropriate statistical analyses to estimate duration of survival or quality of life.  Follow-up duration in most studies was insufficient to determine recurrence rates after RFA from viable tumor cells remaining in situ at ablation sites.  A particular concern with the available data is that patient selection criteria and rationale for using RFA were not well described or did not provide a compelling argument to use the technique in lieu of potentially curative surgical resection or extirpation. 

Several review articles and case series summarized results of RFA in renal tumors. (62, 72, 74, 75) These were all from poorly designed studies involving no control group or randomization and leading to possible selection bias.  All studies centered around the feasibility and safety of RFA in treating renal tumors and involved very specific patient characteristics in order to be enrolled in their studies, making it difficult to apply to the general population who would potentially be getting this. These studies did not report on loss of patients or if data from those lost were still used in their analysis. In total, the available evidence is insufficient to permit conclusions on net health outcomes of RFA for renal cancers. 

Breast Cancer

Four uncontrolled pilot studies published through June 2004 enrolled 77 patients given RFA to treat primary breast cancer. 31-34  One of these reported preliminary data from an ongoing trial (32). In each study, RFA was performed no more than two weeks before definitive surgery (e.g., lumpectomy, quadrantectomy, and modified radical mastectomy). In many patients, RFA was performed immediately before surgery (33). Complete coagulation necrosis was reported in 90% of the excised tumors, with no reported complications from RFA. None of the studies reported that presurgical RFA altered surgical decisions of either the patient or surgeon. Investigators of each study acknowledged the preliminary nature of their reports and the pilot status of their studies on effectiveness of RFA as a potential alternative to excision. 

Several review articles and case series summarized results of RFA in the treatment of  breast cancer. (64, 65, 73) These all indicated that the patient populations were small and the studies were short-term lending to the uncertainty of being able to apply RFA to other patients in the general population or the durability of the results. Another confounding issue in most of these studies was the RFA was done as an adjuvant treatment to actual surgery, so the efficacy of RFA alone is uncertain. In one review the author states clearly that RFA should be restricted to the clinical trial setting until further larger and longer term studies can be done. (73) The available evidence is insufficient to permit conclusions on net health outcomes of RFA for breast cancer.

Pulmonary Tumors

RFA has been used to treat pulmonary tumors in more than 500 patients worldwide (35-49). One of the larger recent studies reported the use of RFA in 30 patients who underwent ablation for 36 total lesions for a spectrum of primary (n=18) and secondary (n=11) lung tumors, mesothelioma (n=1), and five cases of secondarily eroded, painful ribs. (49) Patients were not considered surgical candidates because they had medical comorbidities or extensive disease; they had exhausted chemotherapy and radiotherapy options; or they had “refused” surgery or undergone “unsuccessful” surgery.  All ablations were deemed “technically successful”.  Contrast-enhanced CT or enhanced MRI studies demonstrated necrosis of 90% or better in 26 of 29 (89.7%) patients with lung lesions; pain was ameliorated in 11 of 11 (100%) who rep9orted painful lesions.  The longest follow-up without recurrence was 26 months.  Complications included hemoptysis (n=4) pneumothorax (n=8), atrial fibrillation (n=1), respiratory difficulty (n=2), hoarseness (n=1) and a small third-degree burn in one case.  Post-procedure FDG-PET showed loss of virtually all FDG activity in 9 of 10 (90%) previously positive tumors that were examined with this technology.

One retrospective study reported long-term (up to 5 years of follow-up) efficacy and safety of RFA in patients (n = 153 total) with primary or metastatic pulmonary cancers. (58) A 5-year survival rate of 27% for RFA in stage IA or B non-small cell lung cancer and 57% for metastatic colorectal cancer lesions suggests this technique holds promise for treatment of non-resectable pulmonary lesions. However, these results are compromised by the retrospective nature of the data; the potential confounding effects of undefined prior and adjuvant chemo- or radiotherapy; lack of histopathologic proof of treatment completeness; substantial patient and disease heterogeneity; and failure to separate overall survival rates according to disease. Other case series were reported for RFA of primary and metastatic pulmonary lesions, but none provide convincing evidence for its efficacy. (59-60, 76)

There is ongoing interest in using RFA in pulmonary tumors. However, the identified studies are all small case series or uncontrolled cohort studies which focused primarily on technical feasibility and initial tumor response.  Study quality concerns included lack of long-term follow-up; significant interstudy heterogeneity in terms of study design, patient populations and RFA methods used; and, non-uniformity of reporting and efficacy scoring criteria.  (71) In total, the available evidence is insufficient to permit conclusions on net health outcomes of RFA for pulmonary cancers.

Osteoid Tumors

Rosenthal and colleagues (50) retrospectively compared outcomes for a consecutive series of osteoid osteoma patients treated by operative excision (n=87; 68 primary, 19 recurrent) or by RFA (n=38; 33 primary, five recurrent). With an average time to last follow-up of almost 9 years, the study reported "no significant difference with regard to the rate of clinical success" for the 2 approaches (rates of recurrence: 11% RFA, 9% surgery), no difference in complications (0% RFA, 2% surgery), and lesser need for hospitalization with RFA. Based on these results, the investigators concluded, "the percutaneous method is preferred for the treatment of extraspinal osteoid osteomas."  Cioni and colleagues reported on a case series of 38 patients with osteoid osteoma diagnosed clinically, and by radiography, scintigraphy, contrast enhanced MRI and CT. (51)  A total of 30 of the 38 patients reported prompt pain relief.  Six of the remaining 8 patients underwent successful retreatment, and two underwent surgical excision.

Methodologic issues raise questions regarding the validity of this conclusion. Up to one third of each patient group may not have had osteomas, since only 60% and 66% of those in the surgery and RFA groups, respectively, underwent a biopsy preoperatively, and pathology on operative specimens failed to confirm the diagnosis for an unspecified number. Nevertheless, results were aggregated for all who received each treatment. Furthermore, patients included in this retrospective analysis were treated between 1978 and 1995, but those given RFA were treated in 1990 or later, and few (i.e., <10% annually) were treated surgically in the study’s final years. Comparisons to historical rather than concurrent controls can bias conclusions, particularly since operative techniques have evolved over time. Also, the authors did not report selection criteria for assigning treatment during years when both treatments were used in this non-randomized study. Thus, patient selection bias further threatens the validity of this comparison.

Finally, long-term clinical success (i.e., after 2 years of initial follow-up) was measured using patient responses to a mailed survey with questions on the need for additional procedures, pain medications, and presence of symptoms. The authors reported only a 31% response rate for operative patients, compared with a 68% response rate for those given RFA. They ascribe this difference to the longer time since operative treatment, yet did not limit their analysis to the period when both treatments were in use. They also did not report efforts to increase survey response rates by telephone contact or other measures. The differences in response rates also threaten the validity of their conclusions.

Another recent case series reported primary success in 37 of 38 (97%) patients (25 males, 8 females, age range 5-43 years) who underwent CT-guided percutaneous RFA to treat clinically and radiologically suspected osteoid osteoma. (52) Lesions were located in the proximal femur (n=13), tibia (n=5), foot (n=5), spine and fibula (n=3 each), acetabulum and humerus (n=2 each) and five in other sites.  All patients experienced sufficient pain relief to permit resumption of normal activities within 24 hours of the procedure.  During follow-up ranging from 3-24 months, no major complications were reported.

Small case series studies continue to be published regarding RFA in the treatment of osteoid osteomas. (68) Despite the weaknesses in the published clinical evidence, radiofrequency ablation of osteomas has become a standard of care based on the lower morbidity and quicker recovery time associated with the procedure compared to the standard alternative which is open surgery.

Palliation of Pain From Bone Metastases

Goetz and colleagues reported an international study (n=43) conducted at nine centers in which patients with painful osteolytic bone metastases were treated palliatively with RFA. (53)  The study’s primary outcome measure was the Brief Pain Inventory-Short Form, a validated scale from 0 for no pain to 10 for worst pain imaginable.  Patient eligibility required baseline values ≥ 4 from ≤ 2 painful sites.  Thirty-nine (91%) of the patients had previously received opioids to control pain from the lesion(s) treated with RFA, and 32 (74%) had prior radiation therapy to the same lesion.  Mean pain score at baseline was 7.9 (range, 4 to 10).  At 4, 12, and 24 weeks after RFA, average pain scores decreased to 4.5, 3.0, and 1.4 respectively (all p≤0.0005).  Forty-one (95%) of the patients achieved a clinically significant improvement in pain scores, prospectively defined as a decrease of 2 units from baseline.  Investigators also reported statistically significant (p=0.01) decreases in opioid usage at weeks 8 (by 59%) and 12 (by 54%).

An earlier case series showed that palliative RFA provided significant pain relief in 9 of 10 (90%) patients with unresectable osteolytic spine metastases who had no other treatment options. (54) Pain was reduced by an average of 74%; back pain-related disability was reduced by an average of 27%.  Neurologic function was preserved in nine patients and improved in one.

These uncontrolled studies include only a limited number of cases.  However, the patient population comprised individuals with limited or no treatment options for whom short-term pain relief is an appropriate outcome.  Therefore, the use of RFA as palliative therapy in patients with painful metastatic bone lesions is considered medically necessary.  To date only small poorly designed case series studies have been found that address RFA as an initial treatment to painful metastatic bone tumors. (67) Because data were inadequate or unavailable on use of RFA as initial therapy for pain from bone metastases, this indication remains investigational.  Additionally, Neither setting is addressed in the NCCN guidelines for the treatment of bone cancers.

Miscellaneous

One case series of thirteen patients with adrenal neoplasms treated with RF ablation was identified. Eleven of the 13 lesions were treated successfully with RF ablation, defined by follow up CT scans, and normalization of preprocedural biochemical abnormalities. (55)

Another single-arm, retrospective, paired-comparison study evaluated the short-term efficacy of RFA in relationship to pain and functional impact in patients with unresectable painful soft tissue neoplasms recalcitrant to conventional therapies. (56) Patients had tumors located in a variety of sites including the chest wall, pelvis, breast, perirectal, renal, aortocaval, retroperitoneal and superficial soft tissues.  All had exhausted conventional methods of palliation or experienced dose-limiting adverse effects from pain medication.  Although not all Brief Pain Inventory scores were statistically significant, all means scores trended down with increased time post-ablation.  Complications from RFA were minor or insignificant in all but one patient who had skin breakdown and infection of the ablated superficial tumor site.

Finally, a recent case series showed palliative CT-guided RFA provided subjective improvement with regard to pain, appearance and function in twelve patients who had recurrent and advanced head and neck malignancies and were not candidates for radiation or surgery. (57) The procedure was deemed reasonably safe and feasible for this indication, but further study is needed.

Additional reviews of RFA examined its use in solid malignancies. (66, 69, 70) Although most authors suggest RFA may have a role in treatment of solid non-hepatic malignancies, none provides sufficient evidence to alter the existing policy statements. In summary, the available evidence is insufficient to permit conclusions on net health outcomes of RFA for any of the miscellaneous cancers discussed in this section.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.91
2. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.95
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