Clinical UM Guideline

 

Subject: Radiofrequency Ablation to Treat Tumors Outside the Liver
Guideline #: CG-SURG-62 Publish Date:    12/27/2017
Status: New Last Review Date:    11/02/2017

Description

This document addresses the use of radiofrequency ablation (RFA) as a treatment for benign tumors and primary or secondary malignancies outside the liver.

Note: For additional information see the following topics:

Clinical Indications

Medically Necessary:

  1. Radiofrequency ablation of osteoid osteomas is considered medically necessary.
  2. Radiofrequency ablation of painful bony metastases is considered medically necessary in individuals who have failed or who are considered poor candidates for standard treatments such as opioids or radiation therapy.
  3. Radiofrequency ablation for clinically localized, suspected renal malignancy is considered medically necessary for individuals with peripheral lesions that are less than or equal to 4 cm in diameter and when one or more of the following criteria are met:
    1. Individual has a single kidney; or
    2. Individual has renal insufficiency as defined by a glomerular filtration rate (GFR) of less than or equal to 60 mL/min/m2; or
    3. Individual is considered a high-risk surgical candidate.
  4. Radiofrequency ablation of biopsy-proven non-small cell lung cancer (NSCLC) is considered medically necessary when all of the following criteria are met:
    1. Surgical or radiation treatment with curative intent is considered appropriate based on stage of disease, however medical co-morbidity renders the individual unfit for those interventions; and
    2. No tumor has a maximum diameter of greater than 3.0 cm; and
    3. Tumors are located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart.
  5. Radiofrequency ablation of metastatic malignant tumor(s) to the lung is considered medically necessary when all of the following criteria are met:
    1. Biopsy-proven lung metastasis(es) from an extra-pulmonary primary site; and
    2. Surgical or radiation treatment is considered appropriate based on stage of disease, however medical co-morbidity renders the individual unfit for those interventions; and
    3. There is no current active extra-pulmonary disease; and
    4. There are no more than 3 tumors per lung; and
    5. No tumor has a maximum diameter greater than 3.0 cm; and
    6. Tumors are located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart; and
    7. If a repeat procedure, at least 12 months have elapsed since the prior ablation.

Not Medically Necessary:

Other applications of radiofrequency ablation to treat tumors outside the liver are considered not medically necessary, including but not limited to: breast cancer, breast fibroadenomas, head and neck tumors, adrenal cancer, chordoma, ovarian cancer, and pelvic/abdominal metastases of unspecified origin.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Bone

CPT

 

20982

Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; radiofrequency

 

 

ICD-10 Diagnosis

 

C79.51

Secondary malignant neoplasm of bone 

D16.00-D16.9

Benign neoplasm of bone and articular cartilage

Renal, lung:

CPT

 

32998

Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; radiofrequency

50542

Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed [when specified as radiofrequency ablation]

50592

Ablation, 1 or more renal tumor(s), percutaneous, unilateral, radiofrequency

 

 

ICD-10 Procedure

 

 

For the following codes when specified as radiofrequency ablation:

0B5K3ZZ-0B5M3ZZ

Destruction of lung, percutaneous approach [right, left, bilateral; includes codes 0B5K3ZZ, 0B5L3ZZ, 0B5M3ZZ]

0T500ZZ-0T514ZZ

Destruction of kidney [right or left, by approach; includes codes 0T500ZZ, 0T503ZZ, 0T504ZZ, 0T510ZZ, 0T513ZZ, 0T514ZZ]

0T530ZZ-0T544ZZ

Destruction of kidney pelvis [right or left, by approach; includes codes 0T530ZZ, 0T533ZZ, 0T534ZZ, 0T540ZZ, 0T543ZZ, 0T544ZZ]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

Discussion/General Information

Background/Overview:

RFA is used to treat inoperable tumors or to treat individuals 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 individuals 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 (for example, 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 (for example, intestinal damage during RFA of kidney), structural damage along the probe track (for example, pneumothorax as a consequence of procedures on the lung), hemorrhage, abscess formation, infection, 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 the use of RFA to treat other tumors and 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 (for example, preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).

Bone metastases: After lung and liver, bone is the third most common metastatic site and is relatively frequent among individuals 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 individuals, 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.

Breast tumors: Early-stage primary breast tumors are typically treated surgically.  The selection of lumpectomy, modified radical mastectomy, or another approach balances the individual’s desire for breast conservation, the need for tumor-free margins in resected tissue, and 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, and they are typically surgically excised.  RFA is being investigated as another alternative for treatment of breast tumors and fibroadenomas.

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 (for example, 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.  The effectiveness of RFA for ablation of osteomas and pain relief has been demonstrated in clinical studies.

Pulmonary tumors: Primary lung cancers are usually 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.  Individuals 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 health, inoperability of most metastatic lesions, and lack of evidence for benefit to the individual.

Renal cell carcinoma and other renal tumors: Localized renal cell carcinoma (RCC) is treated by radical nephrectomy or nephron-sparing surgery.  Based on staging results, adjuvant immunotherapy or chemotherapy may be utilized.  Zisman and colleagues (2002) reported the natural progression of RCC is influenced by many variables in addition to the pathology.  As such, alternative staging systems are being investigated to improve identification and stratification of risk factors correlated with prognoses to facilitate treatment decisions  Although long-term controlled trials have not been reported, case series and systematic reviews have reported RFA as relatively safe and with low complication rate to ablate renal tumors < 4 cm in diameter.

Rationale:

Osteoid Osteoma

The use of radiofrequency ablation (RFA) has been demonstrated in several case series to be an effective treatment of osteoid osteoma.  In the largest case series involving 126 individuals treated over an 11-year period, complete pain relief at 2 years was noted in 89% of participants (Rosenthal, 1998).  In another study, Rimondi and colleagues (2005) were able to demonstrate an 85% primary success in 82 out of 97 participants.  Secondary success was achieved in 15 individuals (15%).  There were no treatment related complications.  A smaller study by Martel (2005) reported a 97% primary success rate with RFA in 38 individuals. The secondary success rate was 100% in this study.  Knudsen and colleagues (2015) reported the results of a case series study involving 52 subjects who underwent CT-guided RFA of osteoid osteomas in the extremities.  The response rate after two treatments was 98%, with no major adverse events.

Flanigan (2014) reported results of a case series of 28 individuals with osteoid osteoma treated with intraoperative RFA performed by one surgeon.  The technical success was reported at 100% with no intraoperative or post-operative complications.  One individual was lost to follow-up and 27 individuals were evaluable at the end of the study period.  At the mean follow-up of 31.1 months (range, 5.2-55.8 months), 26 (92.8%) individuals reported complete relief from pain and no evidence of recurrence.  There were two recurrences after RFA recorded.  One individual had repeat RFA 2 months after the initial treatment, and no recurrence was evident at the close of the study.  The second individual was also treated with a repeat RFA treatment, but was lost to follow-up.

Painful Bony Metastases

Goetz and colleagues (2004) reported on an international study of 43 individuals with painful bony metastases treated at nine centers.  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. Selection criteria required baseline values > 4 from two or fewer painful sites.  Thirty-nine (91%) of the individuals had previously received opioids to control pain and 32 (74%) had prior radiation therapy to the same lesion.  Mean pain score at baseline was 7.9. At 4, 12 and 24 weeks after RFA, average pain score decreased to 4.5, 3.0 and 1.4, respectively.  While this uncontrolled study includes a limited number of participants, the study population focused on those with limited other alternatives and in those where short term pain relief was an appropriate outcome (Goetz, 2004).

Renal Cell Carcinoma (RCC) and other renal tumors

The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology® for Kidney Cancer (V.1.2018) include surgical resection as an effective therapy for clinically localized RCC, with options including radical nephrectomy and nephron-sparing surgery.  Individuals with stage I through III tumors and in satisfactory medical condition are recommended to undergo surgical excision.  Active surveillance or ablative techniques, such as RFA or cryoablation are alternative strategies for selected individuals such as the elderly and those with comorbid health risk factors and who are not surgical candidates.

The American Urological Association’s Practice Guidelines Committee reviewed the literature and provided management guidelines for clinical T1 renal mass (Novick, 2009).  The recommendations divided individuals into four groups based on indices such as tumor size.  The reviewers noted “tumors greater than 3.5 cm and those with irregular shape or infiltrative appearance may be associated with increased risk of recurrence when managed with thermal ablation.”  Surgical excision remained the standard of care for healthy individuals (Index 1) with T1a (less than or equal to 4.0 cm) renal masses, and for those with increased surgical risk (Index 2).  Thermal ablation as a less-invasive option is available for healthy individuals, and is recommended for high surgical risk individuals.  For T1b (greater than 4.0 cm to less than 7.0 cm) healthy individuals (Index 3), standard of care is a radical nephrectomy if a normal contralateral kidney is present.  The panel listed thermal ablation as an option for individuals with T1b masses.

Currently, there are only a small number of controlled studies available addressing the use of RFA for RCC.  The largest was a retrospective, nonrandomized comparative study involving 385 subjects with renal masses ≤ 3.0 cm who underwent treatment with either RFA (n=256 tumors in 222 subjects) or cryoablation (n=189 tumors in 163 subjects) (Atwell, 2013).  Subjects were selected for percutaneous ablation due to either high surgical risk or prior renal surgery.  A total of 152 out of 256 tumors were biopsied prior to treatment with RFA, and 102 were confirmed malignancies, 27 were benign, and 23 were unclassified.  For the cryoablation group, these numbers were 91, 28, and 21, respectively.  Subjects treated with RFA were more likely to have no prior renal cancer history (p=0.043), and were significantly more likely to have been followed for at least 3 months (p=0.023).  Mean tumor size was significantly greater in the cryoablation group (p<0.001), and cryoablation was conducted more frequently for centrally located tumors (p<0.001).  Thirteen subjects underwent treatment with both modalities.  Treatment failures were reported in 1 RFA case and 4 cryoablation cases (p=0.017).  Major complications were reported in 10 (4.3%) RFA cases and 9 (5.1%) of cryoablation cases (p=0.91).  Out of the 363 subjects followed for at least 3 months, 218 were in the RFA group and 145 were in the cryoablation group.  Recurrence was reported to have occurred in 7 (3.2%) of RFA subjects at a mean of 2.8 years and in 4 (2.8%) of cryoablation subjects at a mean of 0.9 years.  Estimated 1-, 3- and 5-year survival rates for the RFA group were 100%. 97.2% and 93%, respectively.  For the cryoablation group, these rates were 98.3%, 95.6%, and 95.6%, respectively. A significant difference was noted in favor of the cryoablation group (p=0.048).  Of the tumors with at least 3 months of data, 136 were RCC, and 75 were treated with RFA and 61 were treated with cryoablation.  Only one RFA-treated tumor had a recurrence vs. three in the cryoablation group.  Estimated 1-, 3-, and 5-year recurrence-free survival for the RFA group was 100%, 98.1%, and 98.1% respectively.  For the cryoablation group, these rates were 97.3%, 90.6%, and 90.6%, respectively.  No significant differences were noted between groups (p=0.09).  The authors noted that both RFA and cryoablation are effective in the treatment of renal masses less than or equal to 3 cm, with low complication rates.

A nonrandomized controlled comparative trial was reported by Sung and colleagues (2013) that included 150 subjects with renal masses undergoing either RFA (n=40) or open partial nephrectomy (OPN, n=110).  Tumor size and location were matched between the two groups and there were no significant demographic or other clinical differences between groups.  The mean reduction in estimated glomerular filtration rates (eGFR) in the RFA and OPN groups were 2.3 ± 8.6 mL/min/1.73m2 and 7.4 ± 10.9 mL/min/1.73m2 (p=0.013).  Overall 3-year recurrence-free survival rates in the RFA and OPN groups were 94.7% and 98.9%, respectively (p=0.266).  The authors concluded that for RCC, RFA is superior to OPN with respect to the preservation of renal function.  They also stated that RFA can achieve excellent mid-term outcomes that are equivalent to those of OPN.

In 2015, Chang and colleagues reported the results of a retrospective non-controlled trial involving 90 subjects, 45 of whom underwent treatment with RFA and 45 who received treatment with partial nephrectomy.  For RFA vs. partial nephrectomy, 5-year overall survival was 90.2% vs. 93.2%, 5-year cancer-specific survival was 95.6% vs. 97.7%, 5-year disease-free survival was 86.7% vs. 88.5%, 5-year recurrence-free survival was 95.4% vs. 97.7%, and 5-year metastasis-free survival was 95.5% vs. 95.5%.  No p-values were provided for any comparisons.  The authors stated that age was the only factor that was a predictive factor in disease-free survival (p=0.044).  The percentage decrease in the glomerular filtration rate was significantly lower in the RFA group at the time of last follow-up (p=0.001).  The conclusion was that RFA was an effective treatment option that provided comparable 5-year oncologic outcomes and better preservation of renal function than partial nephrectomy.

The remainder of the evidence addressing the use of RFA for RCCs comes in the form of case series studies.  One of the largest studies was a retrospective report involving 274 subjects with 292 small RCC tumors (Leveillee, 2013).  Benign tumors accounted for 26% (n=77) of the treated lesions, with the remaining 37% (n=197) being RCC.  Anteriorly located tumors were treated with laparoscopic RFA (n=112) and posteriorly located tumors were treated with CT-guided RFA (n=180).  No attempt to make a distinction between subjects with ‘incomplete ablation’ and ‘local recurrence’ was made.  Mean tumor size was 2.54 cm (0.7–5.3 cm) and the mean reported follow-up was 26 months (range 1-98 months).  The primary ablation success rate was reported to be 96% with 11 radiographic recurrences reported and 6 had biopsy-confirmed RCC recurrences.  The 3-year and 5-year cancer-specific survival was 100% and 98.6%, respectively, and the overall 3-year and 5-year survival rate was 90.4% and 74.2%, respectively.  Only tumor size was found to be a predictor of radiographic failure (p=0.007).  Two treatment failures were reported, both in the CT-guided group.  Of the 292 ablations performed in 274 operations, the complication rate was 27% (n=75).  The CT-guided group accounted for 65% of total complications, and 87% of total complications were minor (Clavien grade I or II).

Outcomes of 187 RFA procedures in 149 individuals were described in six small uncontrolled studies (Farrell, 2003; Gervais, 2003; Lewin, 2004; Mayo-Smith, 2003; Pavlovich, 2002; Rendon, 2002; Zagoria, 2004).  The characteristics of the individuals and RFA procedures varied widely within and across the six studies in terms of tumor type (e.g., exophytic, parenchymal, central, with or without history of von Hipple-Lindau disease), tumor size (from less than 1 cm to greater than 5 cm), length of follow-up (from less than 1 month to greater than 36 months), imaging modality used for guidance, and reason for using RFA.  Overall, 88% of procedures were considered successful shortly after 1 or 2 ablations (for example, no signs of residual tumor by histologic analysis after excision or by post-RFA radiologic imaging).  Significant but nonfatal complications were reported in 8% to 10% of individuals in two studies, including perinephric hematomas, hemorrhage, and ureteral strictures.

A study by Clark and colleagues (2006) of 22 individuals with 26 small RCC lesions had mean tumor volume decreases at a mean follow-up of 11.2 months.  Although the article reported on the technical success of the procedure, the short-term follow-up, progression-free and overall survival (OS) data were not provided.  In 2006, Lam and colleagues concluded there were conflicting outcomes from RFA trials.  Additional clinical data was needed about RFA “before its true clinical efficacy and renal applicability can be determined.”  The recommendation for additional randomized controlled, long-term clinical trials was also noted by Veltri (2006) and Park (2006).

In 2016, Yin and colleagues reported the results of a meta-analysis of studies to evaluate radiofrequency ablation versus partial nephrectomy (PN).  Twelve retrospective studies that compared RFA with PN in the treatment of small renal tumors met the selection criterion and were included in this meta-analysis.  The pooled results indicated that the local recurrence rate (4.14% vs 4.10%) and distant metastases rate (2.76% vs 1.89%) were not significantly different between the RFA group and the PN group (p = 0.55 and p = 0.686, respectively).  RFA was reported to be associated with shorter length of stay (p < 0.001) and lower eGFR decline after treatment (p = 0.006).  However, no significant differences were noted between groups with regard perioperative complication rate (7.5% vs 6.2%; p = 0.740) and the major complication rate (3.7% vs 4.4%; p = 0.579).  The authors concluded that RFA achieved an equal oncological outcome for small renal tumors compared to partial nephrectomy.

The currently available, peer-reviewed medical literature reveals that RFA is safe and effective for managing small, undefined peripheral renal masses (< 4 cm); treating solitary kidneys or situations where the contra-lateral kidney is functioning poorly, and treating individuals who have significant comorbidities and cannot tolerate nephrectomy.

Pulmonary Tumors 

Surgical resection is the primary standard of care and preferred local treatment for early stage, NSCLC tumors (Lencioni, 2008; NCCN, V.4.2017).  The surgical procedure is dependent on the extent of the disease, any comorbid conditions, and the individual’s cardiopulmonary reserves.  The NCCN Guidelines® for Non-Small Cell Lung Cancer (V.8.2017) also include a discussion of ablation as non-first line therapy.

Safi and colleagues (2015) conducted a retrospective nonrandomized controlled study of 116 subjects with histologically proven clinical stage I NSCLC who were treated with sublobar resection (SLR; n=42), RFA (n=25), or radiotherapy (RT; n=49).  The SLR subjects were younger and exhibited better performance status, and the RT subjects had larger tumors.  After adjusting for age and tumor size, there were differences between the treatments in terms of the primary recurrence rate, but no differences were observed in overall survival or disease-free survival.  The hazard ratio for primary recurrence comparing SLR versus RT adjusted for age and tumor size was 2.73 (95% confidence interval [CI], 0.72-10.27) and for SLR versus RFA was 7.57 (95% CI, 1.94-29.47).  The authors concluded that SLR was associated with a higher primary tumor control rate compared to RFA or RT, although the overall survival rates were not different.

Another retrospective nonrandomized controlled trial was reported by Ochiai in 2015.  This study involved 48 subjects with single, NSCLC lung tumor treated with RFA vs. 47 treated with stereotactic body radiotherapy (SBRT).  The mean maximum tumor diameter was 2.0 cm (range 0.6-3.9 cm) in the RFA group, and 2.1 cm (range 0.8-4.7 cm, p=0.539) in the SBRT group.  The RFA and SBRT groups showed similar 3-year local tumor progression (9.6%, vs. 7.0%, p=0.746) and overall survival rates (86.4% vs. 79.6%, p=0.738).  No factor significantly affected local tumor progression.  A maximum tumor size of 2 cm was identified as a prognostic factor in both univariate and multivariate analyses.  There were no deaths related to treatment procedures reported.  Major adverse event rates (Grade 3 adverse events) for the RFA group was 10.4% (5/48) and 8.5% (4/47) for the SBRT group (p>0.999).  The authors concluded that for individuals with lung tumors, lung RFA provided local tumor control and survival that were similar to those achieved using SBRT, with equal safety.

Ambrogi and colleagues (2006) reported results from a case series of RFA of 64 pulmonary lesions in 54 individuals with primary NSCLC (40 cases) and metastases from other primary sites in 24 cases.  Technical success was reported on all but two lesions.  The mean size of the lesions was 2.4 cm.  Morbidity included hematoma, pleural effusion and pneumothorax in 12.7% (10 cases).  The mean follow-up period was 23.7 months.  Overall complete response based on radiographs was noted in 39 of 63 lesions (61.9%).  Although statistical significance was not met, RFA was better for lesions less than 3 cm (69.7% vs. 50%) and from extra-thoracic primary malignancies metastatic to the lungs (70.8% vs. 56.4%).  Distant recurrence occurred in 39% (21 cases) and most participants received adjuvant therapy.  While the actuarial median OS is 28.9 months, NSCLC is lower at 18.9 months and for metastatic lesions it is not reached.

Matsui (2015) reported the results of a retrospective case series of 84 subjects with 172 colorectal lung metastases who underwent RFA.  During a median follow-up of 37.5 months, 36 subjects (42.9%) died.  The estimated overall survival rates were 95.2%, 65.0%, and 51.6% at 1, 3, and 5 years, respectively.  Median overall survival time was 67.0 months.  Multivariate analysis revealed that a carcinoembryonic antigen (CEA) level of at least 5 ng/mL before RFA (p=0.03), and the presence of viable extrapulmonary recurrences at the time of RFA (p=0.001), were independent negative prognostic factors.  The local tumor progression rate was 14.0% (24/172).  Grade 3 adverse events were observed after two sessions (1.8%), and no grade 4/5 adverse events were observed.  The paper concluded that RFA of colorectal lung metastases provided favorable long-term survival with a low incidence of severe adverse events.  Independent prognostic factors were a high CEA level before RFA and the presence of viable extrapulmonary recurrences at the time of RFA.

A prospective case series study of 54 subjects with biopsy-proven NSCLC was published in 2015.  Inclusion criteria for this study included a maximum tumor diameter of 3 cm and ECOG status 0-2.  Tumors could not be continuous to vital structures and must have been accessible via the percutaneous route.  Of the original 54 subjects enrolled in the trial, 36 (66.7%) subjects were followed to study completion at 24 months.  Overall survival at 1 and 2 years were 86.3% and 69.8%, respectively.  Local recurrence-free rates were 68.9% and 59.8% respectively.  The presence of local recurrence within 1 year did not affect overall survival (p=0.49).  At 2 years, tumor size less than 2 cm and ECOG status of 0 or 1 were associated with significantly better survival (83% and 63%, respectively).  Grade 3 to 5 adverse events up to 90 days post-intervention were 11.3%.  There were no significant changes in pulmonary function reported at 3 and 24 months, including FEV1, DLCO, except for significant improvement in forced vital capacity at 3 and 24 months (p=0.02 and p<0.01, respectively).

It should be noted that the NCCN guidelines for the treatment of Small Cell Lung Cancer (SCLC, V3.2017), do not recommend the use of RFA.  Surgical resection still represents the standard of care for non-small cell lung cancer, and RFA should be reserved for select individuals who are high-risk for standard therapy.

RFA is being studied as a minimally invasive alternative to surgery for other lung tumors.  Most studies identified are small case series, which focused on technical feasibility and initial pulmonary tumor response (Akeboshi, 2004; Belfiore, 2004; Hiraki, 2007; Jin, 2004; King, 2004; Lee, 2004; Yan, 2007; Yasui, 2004).

Lencioni and colleagues (2008) reported results from a nonrandomized, intention-to-treat, prospective, multi-center trial consisting of 106 individuals with 183 lung tumors.  In the trial, proof of lung malignancy was determined from at least one tumor that was biopsy-proven NSCLC or lung metastasis.  Additional eligibility criteria included individuals that were rejected as surgical candidates and were ineligible for additional treatment with chemotherapy or radiation therapy.  Primary study endpoints were technical success, safety and confirmed complete response (CR) of the targeted tumors. OS, cancer-specific survival and quality of life (QOL) were secondary endpoints.  Treatment was completed in 105 of 106 participants.  Technical placement and treatment of a single metastatic lesion could not be performed in 1 individual.  A total of 137 treatment procedures were done on 105 participants.  Eighty-five (80%) of 106 participants were assessed for primary endpoints.  Seventy-five (88%) of 85 participants had confirmed CR lasting at least a year in all treated tumors.  Out of 85 participants, 10 (12%) had at least one incomplete ablation with disease progression.  Twenty participants died because of tumor progression.  The 1- and 2-year OS rates were 70% (95% CI, 51-83%) and 48% (30-65%) in individuals with NSCLC, 89% (76-95%), and 66% (53-79%) in participants with colorectal cancer (CRC) metastases, and 92% (65-99%) and 64% (43-82%) in individuals with other metastases.  Large, symptomatic pneumothorax requiring drainage via a chest tube occurred in 27 procedures.  Four pleural effusions requiring drainage occurred in 4 participants.  Minor complications included pneumothorax (n=28) and pleural effusion (n=11) that did not require treatment.  Three incidents of self-limiting intrapulmonary hemorrhage occurred.  The median hospital stay was 3 days (range 2-12 days).  Post-treatment pulmonary function tests did not show any significant changes.  Individuals with NSCLC showed a slight decrease in pulmonary function which was deemed consistent with the underlying pulmonary disease.  The authors noted the study population was heterogeneous, and the follow-up period may not have been long enough to detect late tumor recurrences and was not designed to provide evidence of survival benefits.  Therefore, the authors concluded “a randomized controlled trial comparing RFA versus standard treatment options is now warranted to prove the clinical benefit of this approach.”

Zhu and colleagues (2008) performed a systematic review of articles on RFA of lung tumors published through 2006.  Procedure-related morbidity and mortality ranged from 15.2% to 55.6% and 0% to 5.6%, respectively.  Pneumothorax was the most frequently reported complication (4.5-61.1%).  Local recurrence rates ranged from 3% to 38.1% (median=11.2%).  The median progression-free interval ranged from 15 months to 26.7 months (median=21 months), and 1-, 2- and 3-year survival rates were 63-85%, 55-65% and 15-46%, respectively.  The authors concluded there is a growing evidence for the possible use of RFA for lung tumors.  However, there was a wide range of variation in the ablation results and local recurrence rates, and estimated 3-year survival was reported in only 3 of the 17 studies.  The authors noted, “The relatively short follow-up in most studies may suggest that the current experience with RFA is still too immature to reliably establish its therapeutic value.  RFA cannot be considered a therapeutic equivalent to surgical resection.”  RFA may have a potential role in the treatment of non-resectable lung tumors, but defined, clear selection criteria have not been identified.  Randomized control trials comparing RFA and systemic chemotherapy compared with chemotherapy alone would be useful.

Data from an ongoing, prospective, open-labeled trial utilizing RFA on 148 nonsurgical candidates with lung metastases were reported by Chua (2010).  With a median follow-up time of 29 months (range 2-103), 38 individuals had a CR while 30 other participants had a partial response (PR).  Stable disease was noted in 57 individuals and progressive disease in 23 participants.  Overall median PFS was 11 months (95% CI, 9-14 months).  The median OS was 51 months (95% CI, 19-83 months).  Disease progression after RFA was noted in the majority (80%) of the individuals. Local failure at the original ablation site accounted for 5%, progressive disease in other parts of the lung for 32%, in the lung and at other distant sites in 30%, and at other distant metastatic sites for 30%.  Repeat RFA treatment for additional treatment or disease control was done for 28 individuals (19%).  The median OS was 81 months from the first RFA procedure.  The authors concluded the “data demonstrate that prolonged survival may be achieved after RFA of lung metastases.”  Recommendations also included randomized trials of concomitant RFA with systemic therapies and stringent selection criteria to further define the role for treating individuals with lung metastases.

Two case series studies investigating the use of RFA for CRC lung metastases were published in 2013.  The first involved 122 subjects who underwent ablation of 398 lesions during 256 procedures (Gillams, 2013).  The authors reported that the maximum tumor diameter was 1.7 cm (range 0.5–4.0 cm), the adverse event rate was 3.9 %, and median OS and 3-year survival rate were 41 months and 57 %, respectively.  It was noted that survival was better in subjects with smaller tumors. Subjects with tumors ≤ 2 cm had a an OS of 51 months, with a median 3-year survival rate of 64 % vs. an OS of 31 months and 44 % for those subjects with tumors 2.1-4.0 cm (p=0.08).  The number of metastases ablated and whether the tumors were unilateral or bilateral did not affect survival.  The second case series involved 45 subjects who had 69 tumors treated with RFA (Petre, 2013).  In this study, tumor size ranged from 0.4 to 3.5 cm.  Median follow-up after RFA was 18 months, and the median survival from the time of RFA was 46 months.  The 1-, 2- and 3-year OS rates from the time of RFA were 95%, 72%, and 50%, respectively.  The authors reported that 9 of 69 lesions (13%) progressed and 4 were retreated with no progression after second RFA.  Median time to progression was not reached.  Local tumor PFS from RFA was 92% at 1 year, 77% at 2 years, and 77% at 3 years.  They concluded that RFA of lung metastases was an effective minimally invasive, parenchymal-sparing technique that has demonstrated good local control rates in subjects with metastatic pulmonary CRC.

In December 2007, the U.S. Food and Drug Administration (FDA) issued a Public Health Notification: Radiofrequency Ablation of Lung Tumors.  On September 24, 2008, the FDA issued a clarification of the original notice: 

Public health concerns:
FDA has received reports of death and serious injuries associated with the use of RF ablation devices in treatment of lung tumors.  Since we have not reviewed any pre-market clinical data in support of this specific treatment use, we do not know the actual adverse event rate.  Therefore, we cannot say if these deaths or injuries are occurring more frequently than with other forms of treatment for lung tumors.  These adverse events could be related to a number of factors, including selection and management, technical use of the RF device, post procedural treatments, and management of complications.

The regulatory status for RFA devices also noted:

FDA has cleared RF ablation devices for the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis.  This clearance was based only on bench testing data or animal testing performance data.  Under this general indication, RF ablation can be used as a tool to ablate tumors, including lung tumors.

Some RF ablation devices have been cleared for additional specific treatment indications, including partial or complete ablation of non-resectable liver lesions, and palliation of pain associated with metastatic lesions involving bone.  In order for an ablation device to obtain clearance for specific treatment indications, clinical data are necessary to justify the indications by showing that the device, when used on a well-defined target population, consistently achieves the desired treatment effect.

FDA has not cleared any RF ablation devices for the specific treatment indication of partial or complete ablation of lung tumors.  Manufacturers of RF ablation devices cannot legally market them for this treatment indication until they have presented to FDA clinical data sufficient to establish safety and effectiveness for this purpose.  Manufacturers have asked that they be allowed to provide training for clinicians related to this ablation of pulmonary tumor use.  FDA cannot permit manufacturer-sponsored training for a specific indication that has not been cleared.  This does not apply to training that may be available from other sources.”

Published short-term results suggest that RFA treatment of pulmonary malignancies, when surgical resection is contraindicated, appears relatively safe, technically feasible and efficacious with the objective of improving local disease control.  In addition, specialty opinion suggests that RFA may be used as a treatment for pulmonary tumors.

Other Malignancies      

Adrenal neoplasms

One case series of 13 individuals with adrenal neoplasms treated with RFA was identified.  Eleven of the 13 lesions were treated successfully with RF ablation, defined by follow-up CT scans, and normalization of pre-procedural biochemical abnormalities (Mayo-Smith, 2004).

Mendiratta and colleagues (2011) evaluated the use of RFA as a primary treatment for symptomatic primary functional adrenal neoplasms and to determine the efficacy of treatment with use of clinical and biochemical follow-up.  In a retrospective review, the authors evaluated images and medical records from 13 consecutive individuals with symptomatic functional adrenal neoplasms (less than 3.2 cm in diameter) who underwent RFA during a 7-year period.  The authors found that all participants demonstrated resolution of abnormal biochemical markers after ablation (mean biochemical follow-up, 21.2 months).  In addition, all participants experienced resolution of clinical symptoms or syndromes, including hypertension and hypokalemia (in those with aldosteronoma), Cushing syndrome (in the participant with cortisol-secreting tumor), virilizing symptoms (in the participant with testosterone-secreting tumor), and hypertension (in the participant with pheochromocytoma).  For those with aldosteronoma, improvements in hypertension management were noted.  The authors acknowledged the limitations of the study being retrospective and its size.  They noted that larger studies that include those with adenomas and carcinomas may help further determine the value of RFA in the treatment of adrenal tumors, regardless of the functional status of the tumor. 

Yang and colleagues (2016) retrospectively evaluated the safety and efficacy of RFA in 7 individuals with aldosterone-producing adenoma (APA) of the adrenal gland compared to 18 subjects with unilateral adrenal APA with the same tumor size (< 25 mm) who underwent laparoscopic adrenalectomy (LA).  During an interval of 3-6 months of follow-up, the treatment success rate, defined as complete tumor ablation on follow-up CT scan and normalization of serum aldosterone-to-renin ratio, reached 100% in the RFA group versus 94.4% in the LA group.  The authors reported that normalization ability was statistically equivalent in the RFA and the LA groups.  Compared to the LA group, the RFA group demonstrated less post-operative pain (visual analog scale, 2.0 vs. 4.22, p<0.001) and shorter operative time (105 min vs. 194 min, p<0.001).  They concluded that CT-guided percutaneous RFA is effective, safe and is a justifiable alternative for individuals who are reluctant or unfit for laparoscopic surgery for the treatment of APA. 

In a larger study of 63 subjects with APA, Liu and colleagues (2016) retrospectively studied the effectiveness of laparoscopic adrenalectomy (n=27) vs. CT-guided percutaneous RFA (n=36).  They reported that RFA was associated with shorter duration of operation (p<0.001), shorter hospital stay (p<0.001), lower analgesic requirements (p<0.001), and earlier resumption of work (p=0.006).  Morbidity rates were similar in the two groups.  Resolution of primary aldosteronism was seen in 33 of 36 subjects treated with RFA and in all 27 subjects who had laparoscopic adrenalectomy (p=0.180), with median follow-up of 5-7 (range 1.9-10.6) years.  Hypertension was resolved less frequently after treatment with RFA compared with laparoscopic adrenalectomy (p=0.007) and hypokalaemia was resolved in all subjects.  The authors concluded that in this study, RFA was slightly inferior to LA as a treatment of APA. 

Breast Cancer

Four uncontrolled pilot studies included 77 individuals with primary breast cancer were treated with RFA (Fornage, 2004; Hayashi, 2003; Izzo, 2001; Singletary, 2003).  One of these reported preliminary data from an ongoing trial (Hayashi 2003). In each study, RFA was performed no more than 2 weeks before definitive surgery (e.g., lumpectomy, quadrantectomy, and modified radical mastectomy).  In many individuals, RFA was performed immediately before surgery (Izzo, 2001).  Complete coagulation necrosis was reported in 90% of the excised tumors, with no reported complications from RFA.  None of the studies reported that pre-surgical RFA altered surgical decisions of either the individual or surgeon. 

In a nonrandomized study by Oura and colleagues (2007), 52 individuals with small breast tumors were treated by RFA followed by radiation therapy and chemotherapy.  No recurrence was reported in any of the participants at an average of 15 months post procedure.  Cosmesis ratings were excellent in 43 participants, good in 6 individuals, and fair in 3 participants.  However, the small trial was not controlled and the long-term safety and efficacy have not been compared to standard of care. 

A phase II trial investigating ablation after breast lumpectomy added to extend intraoperative margins (ABLATE 1), prospectively enrolled 100 women with breast cancer.  These individuals were treated with lumpectomy followed by intraoperative RFA at a single institution.  Typically, individuals whose tumor margins were < 2 mm were offered re-excisions of the tumor site to optimize the control of local disease.  Excision followed by RFA (eRFA) was hypothesized to reduce “unnecessary re-excision as well as provide equivalent protection against recurrence without radiotherapy (XRT) in selected patients” (Klimberg, 2014).  A total of 22 women had margins that were ≤ 2 mm and 9 women proceeded to mastectomy.  With a median follow-up of 68 months, there were a total of seven recurrences and one contralateral recurrence in the 77 women treated with eRFA for a 5-year DFS rate of 88%, compared to 23 women who received XRT after eRFA where the 5-year DFS was 83% with two local recurrences and three deaths due to metastatic disease.  Although approximately 15% of the entire study population avoided re-excision, the authors noted there were limitations to this study.

The American Society of Breast Surgeons (ASBS, 2017) has provided recommendations for radiofrequency ablation of malignant tumors of the breast.  Specifically, they state:

Percutaneous and/or transcutaneous treatments of malignant tumors of the breast are not specifically approved by the FDA, though some ablative technologies are approved for treatment of benign and malignant soft tissue tumors. Therefore, ablative and percutaneous excisional treatments for breast cancer are considered investigational and should not be performed outside the realm of a clinical trial.

Head and Neck

Owen and colleagues (2011) studied RFA for local control in 21 individuals with recurrent and/or unresectable head and neck cancer (HNC) who failed treatment with surgery, radiation, and/or chemotherapy.  Eight of 13 participants had stable disease after intervention.  Median survival was 127 days.  They concluded that RFA may be a promising palliative treatment alternative for local control and quality of life in those with incurable HNC who have failed standard curative treatment.

Pancreatic cancer

The use of RFA to treat locally advanced pancreatic carcinoma was reported by Giardino and others (2012).  This retrospective case series study involved 107 consecutive subjects who were followed for a minimum of 18 months following RFA treatment.  Subjects were stratified by whether they received RFA as a first-line treatment (n=47) or as a second-line treatment (n=60).  The overall postoperative mortality rate was 1.8%, with one death reportedly due to hepatic failure after a long course of chemotherapy and one death from sepsis after a duodenal perforation.  No complications were reported for 75.0% of subjects.  The overall morbidity rate was 28.0%, of which the abdominal complication rate was 26.1%.  Among these, 17.7% were considered RFA-related complications caused by thermal injuries.  A temperature > 90°C applied to the tumor was found to be the only independent factor related to complications.  The authors reported that the median OS for all subjects was 25.6 months, and 14.7 months for the first-line group and 25.6 months for the second-line group 2 (p=0.004).  Subjects who received the multimodal treatment had an OS of 34.0 months

Two additional case series have been reported on the use of RFA for pancreatic cancers.  Cantore (2012) reported on the treatment of advanced pancreatic carcinoma in 107 subjects.  Subjects received either RFA as a primary treatment (n=47) or following another primary therapy (n=60).  Median overall survival was reported to be 25.6 months.  Median overall survival was significantly shorter in the primary RFA treatment group than in the secondary RFA treatment group (14.7 months vs. 25.6 months; p=0.004).  Subjects who were treated with RFA, radiochemotherapy, and intra-arterial plus systemic chemotherapy (triple-approach strategy) had a median overall survival of 34.0 months.  The authors concluded that RFA after alternative primary treatment was associated with prolonged survival. 

The second study, by Girelli (2013), involved 100 consecutive subjects with Stage III pancreatic ductal adenocarcinoma who received RFA combined with chemoradiotherapy.  RFA treatment was initially given to 48 subjects; 52 subjects had associated palliative surgery.  Abdominal complications occurred in 24 subjects, which were RFA related in 15 cases.  The reported mortality rate was 3%.  At a median follow-up of 12 months, 55 subjects had died of disease and 4 had died due to unknown causes.  Another 19 subjects were alive with disease progression, and 22 were alive and progression-free.

The safety and efficacy of RFA for pancreatic tumors compared to alternative treatment options has not been established.

Thyroid Cancer

At this time, the use of ultrasound-guided RFA for the treatment of thyroid cancer is limited to a single small retrospective nonrandomized controlled study involving 23 subjects with 42 locoregional well-differentiated thyroid carcinomas (Guenette, 2013).  Half of the tumors were treated with RFA and the other half with percutaneous ethanol injection (PEI).  The use of RFA vs. PEI was based on tumor size and location.  Technical failure was reported in 1 case in each treatment group, and both were excluded from the analysis.  The mean tumor size was 1.5 cm, with a range of 0.5-3.7 cm.  Mean follow-up was 61.3 months for the RFA-treated lesions with no progression reported in any RFA-treated sites.  For the PEI treated lesions, mean follow-up was 38.5 months, with disease progression detected in 5 out of 21 subjects (23.8%).  One adverse event was reported in the RFA group, with the subjects having permanent vocal cord paralysis.  The authors conclude that RFA is a safe and effective option for the treatment of thyroid cancer.  However, such conclusions cannot be made on the basis of a single study with weak methodology. 

Definitions

Ablation: The destruction of a body part or tissue or its function. Ablation may be achieved by surgery, hormones, drugs, radiofrequency, heat, or other methods.

Metastasis: The spread of cancer from one part of the body to another. A metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.

Osteoid osteoma: A benign skeletal tumor of unknown etiology that can occur in any bone.

Radiofrequency ablation (RFA): A surgical procedure where cancerous or diseased cells are destroyed using heat produced by high-frequency radio waves.

Unresectable: Refers to a tumor that cannot safely be removed surgically due to size or location.

References

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  75. Zisman A, Pantuck AJ, Wieder J, et al. Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol. 2002; 20(23):4559-4566.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Society of Breast Surgeons. Use of transcutaneous and percutaneous methods for the treatment of benign and malignant tumors of the breast. May 15, 2017. Available at: https://www.breastsurgeons.org/new_layout/about/statements/PDF_Statements/Transcutaneous_Percutaneous.pdf. Accessed on September 15, 2017.
  2. American Urological Association. Ablation of renal masses. 2013. Available at: https://www.auanet.org/education/policy-statements/ablation-of-renal-masses.cfm. Accessed on September 27, 2017.
  3. American Urological Association. Clinically localized prostate cancer: AUA/ASTRO/SUO Guideline. 2017. Available at: http://www.auanet.org/guidelines/clinically-localized-prostate-cancer-new-(aua/astro/suo-guideline-2017). Accessed on September 27, 2017.
  4. American Urological Association. Renal mass and localized renal cancer: AUA guideline. 2017. Available at: http://www.auanet.org/guidelines/renal-mass-and-localized-renal-cancer-new-(2017). Accessed on September 27, 2017.
  5. Donington J, Ferguson M, Mazzone P, et al.; Thoracic Oncology Network of American College of Chest Physicians; Workforce on Evidence-Based Surgery of Society of Thoracic Surgeons. American College of Chest Physicians and Society of Thoracic Surgeons consensus statement for evaluation and management for high-risk patients with stage I non-small cell lung cancer. Chest. 2012; 142(6):1620-1635.
  6. Haugen BR, Alexander EK., Bible KC, et al. 2015 American Thyroid Association Management Guidelines for Adult patients with thyroid nodules and differentiated thyroid cancer: the American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer Thyroid. 2016; 26(1):1-133.
  7. National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology™. © 2017 National Comprehensive Cancer Network, Inc. For additional information: http://www.nccn.org/. Accessed on August 15, 2017.
    • Adult Cancer Pain (V.2.2017). Revised May 10, 2017
    • Basal Cell Skin Cancer V.1.2017. Revised October 3, 2016.
    • Bone Cancer (V.1.2018). Revised August 29, 2017.
    • Breast Cancer (V.2.2016). Revised May 6, 2016.
    • Esophageal and Esophagogastric Junction Cancers (V.2.2017). Revised August 7, 2017.
    • Kidney Cancer (V.1.2018). Revised September 7, 2017.
    • Non-Small Cell Lung Cancer. (V.8.2017). Revised July 14, 2017.
    • Pancreatic Adenocarcinoma (V.3.2017). Revised September 11, 2017.
    • Prostate Cancer (V.2.2017). Revised February 21, 2017.
    • Soft Tissue Sarcoma (V.2.2017). February 8, 2017.
  8. Smallridge RC, Ain KB, Asa SL, et al.; American Thyroid Association Anaplastic Thyroid Cancer Guidelines Taskforce. American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer. Thyroid. 2012; 22(11):1104-1139.
  9. Wells SA Jr, Asa SL, Dralle H, et al. Revised American Thyroid Association Guidelines for the management of medullary thyroid carcinoma: the American Thyroid Association Guidelines Task Force on Medullary Thyroid Carcinoma. Thyroid. 2015; 25(6):567-610.
Websites for Additional Information
  1. American Cancer Society. Available at: http://www.cancer.org. Accessed on September 15, 2017.
  2. National Cancer Institute. Available at: http://www.cancer.gov. Accessed on September 15, 2017.
Index

Bony Metastases, Treatment of
Cancer
Kidney Cancer
Non-Small Cell Lung Cancer
Lung Cancer
Osteoid Osteomas
Radiofrequency Ablation (RFA)
Renal Cell Carcinoma
Solid Tumor

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

New

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review.

New

11/01/2017

Hematology/Oncology Subcommittee review. Initial document development. Moved content of SURG.00050 Radiofrequency Ablation to Treat Tumors Outside the Liver to new clinical utilization management guideline document with the same title.