Archived Policies - Surgery
Microwave Thermotherapy for Primary Breast Cancer
Focused microwave phase array thermotherapy is considered experimental, investigational and/or unproven as a treatment of breast cancer.
Focused microwave phase array thermotherapy has been investigated as a type of heat therapy for treating either primary breast cancer in conjunction with lumpectomy 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).
A literature search based on the MEDLINE database through June 2015 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. (1) 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. (2)
In 2007, reports of two 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. (3) Compared with 13 patients who received only the anthracycline-based regimen, there was greater (88% vs. 59%) tumor volume reduction in the experimental group. Dooley and colleagues (4) 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% (4 of 41 controls) compared with 0% (0 of 34) in the experimental group (p=0.13). These studies provide insufficient data to change the coverage statement. Studies involving larger numbers of patients with longer follow-up of clinical outcomes are needed.
Dooley et al. (5) reviewed the results of four multi-institutional clinical studies of preoperative FMT (focused microwave thermotherapy) for treating invasive carcinomas in the intact breast. In phase I, 8 of 10 (80%) patients receiving a single low dose of FMT prior to receiving mastectomy had a partial tumor response quantified by either ultrasound measurements of tumor volume reduction or by pathologic cell kill. In phase II, the FMT thermal dose was increased to establish a threshold dose to induce 100% pathologic tumor cell kill for invasive carcinomas prior to breast-conserving surgery (BCS). In a randomized study for patients with early-stage invasive breast cancer, of those patients receiving preoperative FMT at ablative temperatures, 0 of 34 (0%) patients had positive tumor margins, whereas positive margins occurred in 4 of 41 (9.8%) of patients receiving BCS alone (P = 0.13). In a randomized study for patients with large tumors, based on ultrasound measurements the median tumor volume reduction was 88.4% (n = 14) for patients receiving FMT and neoadjuvant chemotherapy, compared with 58.8% (n = 10) reduction in the neoadjuvant chemotherapy-alone arm (P = 0.048). They concluded that wide-field adaptive phased-array FMT can be safely administered in a preoperative setting, and data from randomized studies suggest both a reduction in positive tumor margins as a heat-alone treatment for early-stage breast cancer and a reduction in tumor volume when used in combination with anthracycline-based chemotherapy for patients with large breast cancer tumors; larger randomized studies are required to verify these conclusions.
In 2010, Zao and Wu (6) published a systematic review of minimally invasive thermal ablation of early-stage breast cancer, searching in Pubmed, Embase and the Cochrane databases between January 1990 and December 2009. The analyzed studies were almost all feasibility or pilot studies using different energy sources, patients, tumor characteristics and ablation settings. They were conducted in research settings for the assessment of technical safety and feasibility, and none of those was used alone in clinical practice. Despite many methodological differences, complete tumor ablation could be achieved in 76-100% of breast cancer patients treated with radiofrequency ablation, 13-76% in laser ablation, 0-8% in microwave ablation, 36-83% in cryoablation, and 20-100% in high-intensity focused ultrasound ablation. They concluded that minimally-invasive thermal ablation is a promising new tool for local destruction of small carcinomas of the breast; large randomized control studies are required to assess the long-term advantages of minimally-invasive thermal ablation techniques compared to the current breast conserving therapies.
The following randomized clinical trials are ongoing (7):
• 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.
Trials are ongoing, but are no longer recruiting new patients. (8) In addition, this device still does not have clearance or approval from the FDA.
Professional Societies and Guidelines
The American College of Radiology (ACR)
The 2012 ACR states there is insufficient evidence to support the use of other imaging modalities such as thermography, breast specific gamma imaging (BSGI), positron emission mammography (PEM), or optical imaging for breast cancer screening. (9)
National Comprehensive Cancer Network (NCCN)
The NCCN does not address microwave thermotherapy in the 2015 Clinical Practice Guideline on Breast Cancer. (10)
Evidence is limited to small case series for the use of microwave thermotherapy for the treatment of primary breast cancer. Additional randomized studies with a larger number of subjects are needed to evaluate the safety and efficacy of these treatments. Due to the lack of evidence that clinical outcomes are improved, use of focused microwave phase array thermotherapy is considered experimental, investigational and/or unproven as a treatment of breast cancer.
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The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
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1. Gardner RA, Vargas HI, Block JB et al. Focused microwave phased array thermotherapy for primary breast cancer. Ann Surg Oncol 2002; 9(4):326-32.
2. Vargas HI, Dooley WC, Gardner RA et al. Focused microwave phased array thermotherapy for ablation of early-stage breast cancer: results of thermal dose escalation. Ann Surg Oncol 2004; 11(2):139-46.
3. Vargas HI, Dooley WC, Fenn AJ et al. 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 <www.cancer-therapy.org> (Accessed 2015 July 21).
4. Dooley WC, Vargas HI, Fenn AJ et al. Randomized study of preoperative focused microwave phased array thermotherapy for early-stage invasive breast cancer. Cancer Therapy 2008; 6(2):395-408. Available at <www.cancer-therapy.org> (Accessed 2015 July 21).
5. Dooley WC, Vargas HI, et al. Focused microwave thermotherapy for preoperative treatment of invasive breast cancer: a review of clinical studies. Ann Surg Oncol 2010 Apr; 17(4):1076-93. Epub 2009 Dec 22.
6. Zhao Z and F. Wu. Minimally-invasive thermal ablation of early-stage breast cancer: a systemic review. Eur J Surg Oncol 2010 Dec; 36(12):1149-55.
7. Breast Cancer Trials. Available at <www.celsion.com> (Accessed 2015 July 21).
8. Products and Trials. Available at <www.celsion.com> (Accessed 2015 July 21).
9. American College of Radiology (ACR). CR appropriateness criteria. Breast Cancer Screening. 2012. Available at: <www.acr.org> (Accessed 2015 July 21).
10. National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology. Breast Cancer. V2.2015. Available online at: <www.nccn.org> (Accessed 2015 July 21).
11. Microwave Thermotherapy for Primary Breast Cancer. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 January--Archived) Medicine 2.03.06.
|9/15/2015||Document updated with literature review. Coverage unchanged.|
|7/1/2014||Reviewed. No changes. The following was removed: “This document is no longer scheduled for routine literature review and update.”|
|6/1/2013||Document updated with literature review. Coverage unchanged.|
|9/15/2011||Document updated with literature review. Coverage unchanged. This document is no longer scheduled for routine literature review and update.|
|8/15/2009||Routine update with literature review; no changes to coverage statement.|
|9/15/2007||Revised/updated entire document|
|2/1/2005||New medical document|
|Title:||Effective Date:||End Date:|
|Microwave Thermotherapy for Primary Breast Cancer||10-15-2017||07-14-2018|
|Microwave Thermotherapy for Primary Breast Cancer||07-01-2016||10-14-2017|
|Microwave Thermotherapy for Primary Breast Cancer||09-15-2015||06-30-2016|
|Microwave Thermotherapy for Primary Breast Cancer||07-01-2014||09-14-2015|
|Microwave Thermotherapy for Primary Breast Cancer||06-01-2013||06-30-2014|
|Microwave Thermotherapy for Primary Breast Cancer||09-15-2011||05-31-2013|
|Microwave Thermotherapy for Primary Breast Cancer||08-15-2009||09-14-2011|
|Microwave Thermotherapy for Primary Breast Cancer||09-15-2007||08-14-2009|
|Microwave Thermotherapy (MTT) for Primary Breast Cancer||02-01-2005||09-14-2007|