Coverage Policy Manual
Policy #: 2006014
Category: Medicine
Initiated: April 2006
Last Review: October 2018
  Microwave Thermotherapy for Breast Cancer

Description: Focused microwave phase array thermotherapy has been investigated as a type of heat therapy for treating either primary breast cancer in conjunction with lumpectomy y in patients with early stage breast cancer or as a cytoreductive technique in conjunction with preoperative chemotherapy in patients with advanced breast cancer. Microwave applicators are placed on either side of the compressed breast that, when activated, illuminate a large volume of breast tissue. A probe is placed within the breast to monitor the interstitial temperature. The technique is based on the preferential microwave heating that occurs in high-water content breast carcinoma compared to the surrounding lower water content healthy breast tissues. If successful, the microwave therapy could function similarly to the role of whole breast irradiation therapy after breast-conserving surgery, i.e., by destroying microscopic residual cancer cells.

In patients with locally advanced primary breast cancer, microwave thermotherapy may reduce the size of the tumor sufficiently to allow a less invasive surgical procedure to be performed.  Currently, no microwave thermotherapy device that is indicated for the treatment of breast cancer has received approval for marketing from the U.S. Food and Drug Administration (FDA). The Microfocus™ APA 1000 System (Celsion, Columbia, MD) is a device that is currently undergoing clinical trials through the FDA investigational device exemption process (IDE).  The clinical trials are no longer recruiting and no PMA or 510(k) approval could be found for this device.  

In 2003, a category III CPT code was issued that specifically describes microwave thermotherapy.  0061T: Destruction/reduction of malignant breast tumor including breast carcinoma cells in the margins, microwave phased array thermotherapy, disposable catheter with combined temperature monitoring probe and microwave sensor, externally applied microwave energy, including interstitial placement of sensor. (For imaging guidance performed in conjunction with 0061T, see 76942, 76986.)

Policy/
Coverage:
Microwave thermotherapy for breast cancer is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. This procedure continues to be the subject of ongoing clinical trials to determine its safety and effectiveness for the treatment of breast cancer.
 
For contracts without primary coverage criteria, the use of microwave thermotherapy for breast cancer is considered investigational and is not covered.  Investigational services are an exclusion in the member benefit contract.

Rationale:
A literature search based on the MEDLINE database revealed limited published data regarding microwave thermotherapy. Gardner and colleagues reported on the results of a phase I and II clinical trial including 10 patients that reported that the technique is technically feasible.  Vargas and colleagues reported on a dose-finding study in 25 patients, performed as part of an Investigational Device Exemption (IDE) trial. Patients underwent thermotherapy at various doses before undergoing surgical resection of breast cancer to determine whether or not the use of thermotherapy before breast conserving surgery could potentially reduce the incidence of positive surgical margins, and thus the need for re-excision.   
 
The following manufacturer sponsored phase II trials are no longer recruiting patients:
Study 102-00-202
A total of 222 female patients with early-stage primary breast cancer will be randomized (ratio 1:1) either to thermotherapy (at one of two different doses) plus surgery or surgery alone. The primary endpoints include reduction of tumor cells at surgical margins and reduction of second incision rates due to unclean surgical margins.
 
Study 102-00-201
A total of 228 female patients with locally advanced primary breast cancer will be randomized (ratio 1:1) either to chemotherapy plus thermotherapy or chemotherapy alone. The primary endpoints include downsizing from mastectomy to partial mastectomy, and determining the percentage of patients with =85% pathological cell death.
 
Authors of two 2005 review articles all identify microwave therapy as one of a number of minimally invasive treatments for which the efficacy as sole treatment of breast cancer needs to be determined.
 
2006 Update
A search of the literature was performed for the period of 2005. No additional studies were identified that would prompt a reconsideration of the policy statement, which remains unchanged.
 
2007-2008 Update
A search of the literature was conducted using MEDLINE in December 2007. No publications of results of additional clinical studies were identified. Trials are ongoing, but are no longer recruiting new patients. In addition, this device still does not have clearance or approval from the FDA. Thus, the policy statement is unchanged.
 
2009 Update
The policy was updated with a literature search through November 2008. Reports of 2 small studies with early, intermediate outcomes were identified. Vargas and colleagues reported on a study of 15 patients who received preoperative focused-microwave thermotherapy in combination with neoadjuvant anthracycline-based chemotherapy for invasive (T2, T3) breast cancer (Vargas et al, 2007). Compared with 13 patients who received only the anthracycline-based regimen, there was greater (88% vs. 59%) tumor volume reduction in the experimental group. In 2008, Dooley and colleagues reported on a randomized study of preoperative focused-microwave thermotherapy for early-stage breast cancer.  In this study, 34 patients received thermotherapy before surgery and 41 received only surgery. Positive margins were found in 10% compared with 0% in the experimental group. These studies provide insufficient data to change the policy statement. Studies involving larger numbers of patients with longer follow-up of clinical outcomes are needed.
 
2011 Update
A literature search was conducted through October 2011.  There was no literature identified that would prompt a change in the coverage statement.  Microwave thermotherapy is currently being studied in a phase III clinical trial (NCT01204801) for the treatment of women with large breast cancer tumors.
 
2012 Update
A literature search conducted through September 2012 did not identify any new information that would prompt a change in the coverage statement. The phase III clinical trial (NCT01204801) mentioned in the previous policy update is still listed as ongoing on the clinicaltrials.gov website. The policy statement is unchanged.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  No new information was identified that would prompt a change in the coverage statement.
    
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Yamamoto and colleagues conducted a study to test the efficacy and toxicity of hyperthermia in conjunction with chemotherapy for breast cancer) (Yamamoto, 2014). Between 2009 and 2014, 6 patients diagnosed with breast carcinoma were selected for this retrospective study. Patients received standard chemotherapy (AC followed by paclitaxel) in combination with hyperthermia. The hyperthermia device employed microwave heating with water loaded and water-cooled waveguides. The temperature was monitored subcutaneously in the skin under the aperture of the waveguide. Following hyperthermia therapy, 4 patients had a partial response to treatment and the toxicity was mild, consisting of Grade 1 acute skin toxicity. Therefore, hyperthermia combined with chemotherapy for breast cancer seems to be effective and generally tolerable. A larger patient cohort is needed to confirm these results.
 
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Yamamoto and colleagues published a study testing the efficacy and toxicity of hyperthermia for treating breast cancer. Ten patients received treatment (AC, paclitaxel, S-1, and aromatase inhibitor) in combination with hyperthermia. The hyperthermia device was a microwave heating device with water loaded and water-cooled waveguides. The temperature was monitored subcutaneously in the skin under the aperture of the waveguide. Two patients had a partial response to treatment with only mild toxicity (grade 1 acute skin toxicity). Therefore, hyperthermia combined with chemotherapy for treating breast cancer seems to be effective and generally tolerable. A larger patient cohort is needed to confirm these results in the future.
 
2017 Update
A literature search conducted using the MEDLINE database through September 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  

References: Agnese DM, Burak WE Jr.(2005) Ablative approaches to the minimally invasive treatment of breast cancer. Cancer J 2005; 11:77-82.

Dooley WC, Vargas HI, Fenn AJ et al.(2008) Randomized study of preoperative focused microwave phased array thermotherapy for early-stage invasive breast cancer. Cancer Therapy 2008; 6(2):395-408. Available at http://www.cancer-therapy.org/vol6b.pdf

Gardner RA, Vargas HI, et al.(2002) Focused microwave phased array thermotherapy for primary breast cancer. Ann Surg Oncol 2002; 9:326-32.

Huston TL, Simmons RM.(2005) Ablative therapies for the treatment of malignant diseases of the breast. Am J Surg 2005; 189:694-701.

Vargas HI, Dooley WC, et al.(2004) Focused microwave phased array thermotherapy for ablation of early-stage breast cancer: results of thermal dose escalation. Ann Surg Oncol 2004; 11:139-46.

Vargas HI, Dooley WC, Fenn AJ et al.(2007) Study of preoperative focused microwave phased array thermotherapy in combination with neoadjuvant anthracycline-based chemotherapy for large breast carcinomas. Cancer Therapy 2007; 5(2):401-8. Available at http://www.cancer-therapy.org/vol5b.pdf

www.celsion.comm/technology.

Yamamoto C, Yamamoto D, Tsubota Y, et al.(2014) [The synergistic effect of local microwave hyperthermia and chemotherapy for advanced or recurrent breast cancer]. Gan To Kagaku Ryoho. 2014 Nov;41(12):1921-3

Yamamoto C, Yamamoto D, Tsubota Y, et al.(2015) Local Microwave Hyperthermia for Advanced or Recurrent Breast Cancer. Gan To Kagaku Ryoho. 2015 Oct;42(10):1231-3.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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