Archived Policies - Surgery


Radiofrequency Ablation (RFA) of Solid Tumors (Excluding Pulmonary, Renal, and Liver)

Number:SUR701.021

Effective Date:06-15-2011

End Date:05-14-2013

Coverage:

NOTE:  For policy on liver tumors see SUR709.029 Radiofrequency or Cryoablation of Liver Tumors.

NOTE:  For policy on pulmonary tumors see SUR706.012 Radiofrequency Ablation (RFA) of Pulmonary Tumors

NOTE:  For policy on renal cell carcinoma see SUR710.017 Radiofrequency Ablation (RFA) and Cryoablation of Renal Cell Carcinoma (RCC).

Radiofrequency ablation of osteoid osteomas or bony metastases may be considered medically necessary only when determined to be indicated by the treating physician for the following:

  • as palliative treatment of medically or surgically inoperable tumor(s), and/or
  • for patients who have failed or are a poor candidate for standard treatment such as surgical intervention, radiation, chemotherapy, or opioids.

Radiofrequency ablation may be considered medically necessary for treatment of primary and metastatic neoplasms when removal of the neoplasm may be curative but the patient has been determined by the treating physician to be unable to tolerate surgical resection.

Radiofrequency ablation is considered experimental, investigational and unproven for initial treatment of any other tumors.

Description:

Radiofrequency ablation (RFA) is being evaluated to treat various tumors, including inoperable tumors, or to treat patients ineligible for surgery due to age, presence of comorbidities, or poor general health.  Goals of RFA may include controlling local tumor growth and preventing recurrence; palliating symptoms; and/or 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 (US), magnetic resonance imaging (MRI) 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.  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).

The U.S. Food and Drug Administration (FDA) issued a statement September 24, 2008 concerning the regulatory status of RFA.  The FDA has cleared RFA devices for the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis.  Some RFA devices have been cleared for additional specific treatment indications, including partial or complete ablation of nonresectable liver lesions and palliation of pain associated with metastatic lesions involving bone. 

Osteoid osteomas

Osteomas are the most common benign bone tumor, comprising 10–20% of benign and 2–3% of all bone tumors.  They are typically seen in children and young adults, with most diagnosed in patients between 5–20 years of age.  Osteomas are most common in the lower extremity (usually the long bones, mainly the femur), and less common in the spine.  These tumors typically have a characteristic clinical presentation and radiologic appearance, with pain, usually continuous and worse at night, and usually relieved by aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).  The natural history of the osteoid osteoma varies upon its location, and although they rarely exceed 1.5 cm, they may produce bone widening and deformation, limb length inequality, or angular deviations when near a growth plate.  When located in the spine, these lesions may lead to painful scoliosis or torticollis.  Sometimes, they heal spontaneously after 3–7 years.

Treatment options include medical management with NSAIDs (non-steroidal anti-inflammatory drugs), surgical excision (wide/enbloc excision or curetting), or the use of CT- or MRI-guided minimally invasive procedures including core drill excision, laser photocoagulation, or RFA.  For many years, complete surgical excision was the classic treatment of osteomas, usually performed in patients with pain despite medical management.  Complete surgical excision has several disadvantages.  A substantial incision may be necessary and removal of a considerable amount of bone (especially in the neck of the femur), increasing the need for bone grafting and/or internal fixation (which often necessitates a second procedure to remove the metal work).  Other possible risks include avascular necrosis of the femoral head and postoperative pathologic fracture.  In addition, surgical excision leads to a lengthier period of convalescence and postoperative immobilization.  Anatomically inaccessible tumors may not be completely resectable and may recur.  RFA of osteoid osteoma is done with a needle puncture, so there is no incision or sutures needed, and patients may walk on the treated extremity immediately and return to daily activities as soon as the anesthetic effect wears off.  The risk of recurrence with RFA of an osteoma is 5–10%, and recurrent tumors can be retreated with RFA.  In general, RFA is not performed in many spinal osteomas because of possible thermal-related nerve damage.

Breast tumors

There has been a trend in the treatment of small breast cancers from total mastectomy towards increasingly more conservative treatment options like lumpectomy, with more acceptable cosmetic outcomes and preservation of the breast.  The selection of surgical approach balances the patient’s desire for breast conservation and the need for tumor-free margins in resected tissue. Minimally invasive nonsurgical techniques like RFA are appealing if they can produce local control and survival equivalent to breast-conserving surgical alternatives.  Nonsurgical ablative techniques pose difficulties such as the inability to determine tumor size, complete tumor cell killing, and local recurrence.  Additionally, RFA can cause burning of the skin or damage to muscle, possibly limiting the use in patients with tumors near the skin or chest wall.

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.

Head and neck cancer 

In patients with head and neck cancer with recurrent disease, surgical salvage attempts are poor in terms of local control, survival and quality of life, and these recurrent tumors are often untreatable with standard salvage therapies.  Palliative chemotherapy or comfort measures may be offered.  The safety and efficacy of RFA has been investigated as an option for palliative treatment in these situations.

Rationale:

Palliation of pain from bone metastases

Goetz et al. reported on an international study (n=43) conducted at nine centers in which patients with painful osteolytic bone metastases were treated palliatively with RFA.  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 of 4/10 or higher during a 24-hour period from up to two painful sites of metastases involving bone.  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, 4-10).  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 two units from baseline.  Investigators also reported statistically significant (p=0.01) decreases in opioid use at weeks eight (by 59%) and 12 weeks (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.  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 included only a limited number of cases.  However, the patient populations 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.  Because data were unavailable on use of RFA as initial therapy for pain from bone metastases, this indication remains investigational.  Neither setting is addressed in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of bone cancers,

An additional small case series of 24 patients with painful metastatic bone tumors who experienced pain-alleviating effects with RFA supports the policy statement.

Osteoid tumors

In 2003, Rosenthal and colleagues reported their experience over an 11-year period with 271 RFA procedures for osteoid osteomas in 263 patients.  Short-term outcome was evaluated to detect procedure-related problems; by this definition, all procedures were considered technically successful.  Long-term clinical success data (defined as being free of pain without the necessity of additional procedures) was available in 126 patients, with a complete clinical success observed in 89% of them.  For procedures performed as the initial treatment, the success rate was 91%.

In 2004, Cioni and colleagues reported on a case series of 38 patients with osteoid osteoma diagnosed clinically, as well as by radiography, scintigraphy, contrast-enhanced MRI, and CT.  A total of 30 of the 38 patients reported prompt pain relief.  Six of the remaining eight patients underwent successful retreatment, and two underwent surgical excision.

Another recent case series reported primary success in 37 of 38 (97%) patients (25 males, eight females; age range: 5–43 years) who underwent CT-guided percutaneous RFA to treat clinically and radiologically suspected osteoid osteoma.  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.

Breast cancer

Four uncontrolled pilot studies published through June 2004 enrolled 77 patients given RFA to treat primary breast cancer.  One of these reported preliminary data from an ongoing trial.  In each study, RFA was performed no more than two weeks before definitive surgery (e.g., lumpectomy, quadrantectomy, modified radical mastectomy).  In many patients, RFA was performed immediately before surgery.  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. 

Through June 2009, only pilot and feasibility studies have been conducted, consisting of individual case control and cohort studies, and case series; studies have consisted of small numbers of patients.  Further studies, with long-term follow-up, are needed to determine whether RFA for small breast cancers can provide local control and survival rates comparable to conventional breast-conserving treatment.  

The NCCN Guidelines do not address RFA in the management of breast cancer.  In addition, no Phase III trials were identified in the National Cancer Institute Clinical (NCI) Trials Database (PDQ®), but two Phase I/II NCI clinical trials were identified:

  • Pilot study of RFA of breast cancer lumpectomy sites to achieve negative margins without removing large volumes of tissue (NCT00571987), and
  • Study of RFA after single-insertion image guided vacuum assisted biopsy to achieve negative margins in small breast cancers (<1.5 cm) (NCT00574301).

Head and Neck Cancer

A case series showed palliative CT-guided RFA provided subjective improvement with regard to pain, appearance, and function in 12 patients who had recurrent and advanced head and neck malignancies and were not candidates for radiation or surgery.  The procedure was deemed reasonably safe and feasible for this indication, but further study is needed.  In addition, the NCCN Guidelines do not address the use of RFA in head and neck cancer, and search of the NCI clinical trials database returned no current trials on the use of RFA in head and neck cancer.

Other Tumors

One case series of 13 patients with adrenal neoplasms treated with RFA was identified.  Eleven of the 13 lesions were treated successfully with RFA, defined by follow-up CT scans, and normalization of pre-procedural biochemical abnormalities. 

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.  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 mean 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 12 patients who had recurrent and advanced head and neck malignancies and were not candidates for radiation or surgery.  The procedure was deemed reasonably safe and feasible for this indication, but further study is needed.

In total, the available evidence is insufficient to permit conclusions on net health outcomes of RFA for any of the miscellaneous cancers discussed in this section.

2011 Update

Osteoid Tumors

A 2004 National Institute for Clinical Excellence (NICE) Guidance indicates that “current evidence on the safety and efficacy of computed tomography (CT)-guided thermocoagulation of osteoid osteoma appears adequate to support its use, provided that the normal arrangements are in place for consent, audit and clinical governance.”

Breast Tumors

Several small case series were identified in the literature search, all from non-U.S. centers.  These included feasibility studies and a study evaluating the reproducibility of ablation lesion size and cosmetic outcome.  Imoto et al. reported on a series of 30 patients with T1N0 breast cancer who had sentinel node biopsy followed by RFA and breast-conserving surgery.  Twenty-six patients showed pathologic degenerative changes in tumor specimens with hematoxylin-eosin staining and, in 24 of 26 cases, tumor cell viability was diagnosed as negative by nicotinamide adenine dinucleotide diaphorase staining.  Two patients had skin burns and seven had muscle burn related to RFA.  In a 2-stage Phase II clinical trial, patients with histologically confirmed noninflammatory and 3 cm or less ipsilateral breast tumor recurrence were treated with RFA followed by mastectomy.  The study was ended early because of insufficient efficacy of the technique tested.  Authors of a small (n=10) series in which tumor size and fat content was analyzed, concluded that “the fat content of small primary breast cancer could serve as a ‘heat sink’ and should be considered as a preventing factor of complete local tumor destruction by RF thermal ablation.”

Head and Neck

A case series of 14 patients with recurrent advanced head and neck malignancies was reported by Brook et al.  Tumor targeting and electrode deployment was successful in all cases, and four of six patients who completed quality of life assessments showed improvement.  Three major complications (in 27 applications, 11%) occurred seven days to two weeks after the procedure.  These included stroke, carotid artery rupture leading to death, and threatened carotid artery rupture with subsequent stroke.  Retrospective analysis of intraprocedural CT scans revealed that the retractable electrodes were within 1 cm of the carotid artery during ablation in these cases.

2008 National Comprehensive Cancer Network (NCCN) Guidelines do not address the use of RFA in head and neck cancer.  In addition, a search of the NCI clinical trial database returned no current trials on the use of RFA in head and neck cancer.

Other Tumors

Preliminary results of endoscopic RFA of rectosigmoid tumors have been described in a paper by Vavra et al.  Twelve patients were treated with the Endoblate RFA device, with 10 patients having surgical resection after ablation.  Histology of the resected specimens showed that, on average, 82% (range: 60-99) of the tumor mass was destroyed in the ablation zone.

Stereotactic RF thermocoagulation for epileptogenic hypothalamic hamartomas is described in a retrospective analysis of a series of 25 patients with gelastic seizures (a rare type of seizure that involves a sudden burst of energy, usually in the form of laughing or crying).  Other seizure types were exhibited in 22 patients (88.0%), precocious puberty in eight (32.0%), behavioral disorder in 10 (40.0%), and mental retardation in 14 (56.0%).  Gelastic seizures resolved in all but two patients.  Complete seizure freedom was achieved in 19 patients (76.0%).  These patients had disappearance of all seizure types and behavioral disorder and also demonstrated intellectual improvement.

A case series of 94 elderly subjects with solid or mainly solid benign thyroid nodules was reported by an Italian center.  Thyroid nodule volume, compressive symptoms and thyroid function were evaluated at baseline and 12 to 24 months after treatment.  All thyroid nodules significantly decreased in size after RFA.  Compressive symptoms improved in all patients and disappeared completely in 88% of patients.  Hyperthyroidism resolved in most patients allowing methimazole therapy to be completely withdrawn in 79% of patients with pretoxic and toxic thyroid nodules (100% in pretoxic and 53% with toxic thyroid nodules).  The authors observe that RFA is particularly attractive for elderly people for whom surgery and radioiodine therapy are often contraindicated or ineffective.  A smaller series (n=33) also from Italy found similar outcomes in terms of reduction in compressive symptoms and improvement in thyroid function.  Hyperfunction was fully controlled in 24% of patients and partially reduced in the others.

These case series do not allow comparison with available alternative treatments, and the coverage position is unchanged.

Summary

A search of peer reviewed literature through April 2011 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position.  Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

Izzo, F., Thomas, R., et al.  Radiofrequency ablation in patients with primary breast carcinoma: a pilot study in 26 patients.  Cancer (2001) 92(8):2036-44.

Gronemeyer, D.H., Schirp, S., et al.  Image-guided radiofrequency ablation of spinal tumors: preliminary experience with an expandable array electrode.  Cancer Journal (2002) 8(1):33-9.

Hayashi ,A.H., Silver, S.F., et al.  Treatment of invasive breast carcinoma with ultrasound-guided radiofrequency ablation.  American Journal of Surgery (2003) 185(5):429-35.

Singletary, S.E.  Radiofrequency ablation of breast cancer.  The American Surgeon (2003) 69(1):37-40.

Rosenthal DI, Hornicek FJ, Torriani M et al. Osteoid osteoma: percutaneous treatment with radiofrequency energy. Radiology 2003; 229(1):171-5.

Fornage, B.D., Sneige, N., et al.  Small (< or = 2-cm) breast cancer treated with US guided radiofrequency ablation: feasibility study.  Radiology (2004) 231(1):215-24.

Cioni, R., Armillotta, N., et al.  CT-guided radiofrequency ablation of osteoid osteoma: long-term results.  European Radiology (2004) 14(7):1203-8.

Goetz, M.P., Callstrom, M.R., et al.  Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study.  Journal of Clinical Oncology (2004) 22(2):300-6.

Mayo-Smith, W.W., and D.E. Dupuy.  Adrenal neoplasms: CT-guided radiofrequency ablation – preliminary results.  Radiology (2004) 231(1):225-30.

Locklin, J.K., Mannes, A., et al.  Palliation of soft tissue cancer pain with radiofrequency ablation.  Journal of Supportive Oncology (2004) 2(5):439-45.

Owen, R.P., Silver, C.E., et al.  Techniques for radiofrequency ablation of head and neck tumors. Archives of Otolaryngology—Head and Neck Surgery (2004) 130(1):52-6.

Martel, J., Bueno, A., et al.  Percutaneous radiofrequency treatment of osteoid osteoma using cool-tip electrodes.  European Journal of Radiology (2005) 56(3):403-8.

Rosenthal, D.  Radiofrequency Treatment.  Orthopedic Clinics of North America (2006) 37:475-84.

Callstrom, M.R., Charboneau, J.W., et al.  Image-guided ablation of painful metastatic bone tumors: a new and effective approach to a difficult problem.  Skeletal Radiology (2006 Jan) 35(1):1-15.

Ghanem, I.  The management of osteoid osteoma: updates and controversies.  Current Opinions in Pediatrics (2006 Feb) 18(1):36-41.

Soong, M.,  Jupiter, J., et al.  Radiofrequency ablation of osteoid osteoma in the upper extremity. Journal of Hand Surgery American Volume (2006 Feb) 31(2):279-83.

Kojima H, Tanigawa N, Kariya S et al. Clinical assessment of percutaneous radiofrequency ablation for painful metastatic bone tumors. Cardiovasc Intervent Radiol 2006; 29(6):1022-6.

Noguchi M. Is radiofrequency ablation treatment for small breast cancer ready for “prime time”? Breast Cancer Res Treat 2007; 106(3):307-14.

van der Ploeg IM, van Esser S, van den Bosch MA et al. Radiofrequency ablation for breast cancer: a review of the literature. Eur J Surg Oncol 2007; 33(6):673-7.

Oura S, Tamaki T, Hirai I et al. Radiofrequency ablation therapy in patients with breast cancers two centimeters or less in size. Breast Cancer 2007; 14(1):48-54.

Liapi E, Geschwind JF. Transcatheter and ablative therapeutic approaches for solid malignancies. J Clin Oncol 2007; 25(8):978-86.

Spiliotis JD, Datsis AC, Michalopoulos NV et al. Radiofrequency ablation combined with palliative surgery may prolong survival of patients with advanced cancer of the pancreas. Langenbecks Arch Surg 2007; 392(1):55-60.

Brook AL, Gold MM, Miller TS et al. CT-guided radiofrequency ablation in the palliative treatment of recurrent advanced head and neck malignancies. J Vasc Interv Radiol 2008; 19(5):725-35.

Deandrea M, Limone P, Basso E et al. US-guided percutaneous radiofrequency thermal ablation for the treatment of solid benign hyperfunctioning or compressive thyroid nodules. Ultrasound Med Biol. 2008; 34(5):784-91.

Garbay JR, Mathieu MC, Lamuraglia M et al. Radiofrequency thermal ablation of breast cancer local recurrence: a phase II clinical trial. Ann Surg Oncol 2008; 15(11):3222-6.

Imoto S, Wada N, Sakemura N et al. Feasibility study on radiofrequency ablation followed by partial mastectomy for stage I breast cancer patients. Breast 2009; 18(2):130-4.

Athanassiou E, Sioutopoulou D, Vamvakopoulos N et al. The fat content of small primary breast cancer interferes with radiofrequency-induced thermal ablation. Eur Surg Res 2009; 42(1):54-8.

Vavra P, Dostalik J, Zacharoulis D et al. Endoscopic radiofrequency ablation in colorectal cancer: initial clinical results of a new bipolar radiofrequency ablation device. Dis Colon Rectum 2009; 52(2):355-8.

Kameyama S, Murakami H, Masuda H et al. Minimally invasive magnetic resonance imaging-guided stereotactic radiofrequency thermocoagulation for epileptogenic hypothalamic hamartomas. Neurosurgery 2009; 65(3):438-49.

Spiezia S, Garberoglio R, Milone F et al. Thyroid nodules and related symptoms are stably controlled two years after radiofrequency thermal ablation. Thyroid 2009; 19(3):219-25.

Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 October) Surgery 7.01.95.

Policy History:

6/15/2011        Document updated with literature review.  Coverage unchanged.

8/15/2009        Routine update with literature review and no change in coverage 

8/15/2007        New medical document

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