Archived Policies - Surgery


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

Number:SUR701.021

Effective Date:08-15-2007

End Date:08-14-2009

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 used to treat 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 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).

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, 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.

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.

Rationale:

This policy is based on an analysis of relevant literature identified initially in a MEDLINE search performed in June 2003 and updated in December 2005.  MEDLINE was searched again for the period December 2005 through January 2007 for the current revision.  Except for one study, a retrospective comparison of two consecutive series of osteoma patients treated with RFA or open excision, the identified studies primarily comprised were uncontrolled, retrospective or prospective 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 of 10 or more patients.

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.  No new published studies were identified in a literature search updated through December 2005.  The available evidence is insufficient to permit conclusions on net health outcomes of RFA for breast cancer.

Osteoid tumors

Rosenthal et al. 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 nine years, the study reported “no significant difference with regard to the rate of clinical success” for the two 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, that the percutaneous method is preferred for the treatment of extraspinal osteoid osteomas.

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 pathologic examination 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 two 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.

In 2004, 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.  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 other sites (n=5).  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.

In total, while promising, the available evidence is insufficient to permit conclusions on net health outcomes of RFA for osteoid osteomas.

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 guidelines for the treatment of bone cancers,

Miscellaneous

One case series of 13 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. 

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.

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.

Medicare does not have a national position on this service.  It is subject to local carrier discretion. Please refer to the local carrier for more information.

References:

Rosenthal, D.I., Hornicek, F.J., et al.  Percutaneous radiofrequency coagulation of osteoid osteoma compared with operative treatment.  Journal of Bone and Joint Surgery American Volume (1998) 80(6):815-21.

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.

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) 37:475-484.

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.

Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2006 February) Surgery 7.01.95.

Policy History:

Archived Document(s):

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