Medical Policies - Surgery


Microwave Thermotherapy for Primary Breast Cancer

Number:SUR701.020

Effective Date:07-15-2018

Coverage:

This medical policy has become inactive as of the end date above.  There is no current active version and is not to be used for current claims adjudication or business purposes.

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Focused microwave phase array thermotherapy is considered experimental, investigational and/or unproven as a treatment of 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 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.

Regulatory Status

To date, 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). Several microwave ablation systems have received 510(k) approval from the FDA as a class II device for the intended use for coagulation (i.e. ablation of soft tissue). (1, 2) The Microfocus™ APA 1000 System (Celsion, Columbia, MD) is a device that is currently undergoing clinical trials through the FDA investigational device exemption (IDE) process.

Rationale:

A literature search based on the MEDLINE database through August 2017 revealed limited published data regarding microwave thermotherapy. Following is the key published literature to date.

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. (3) 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. (4)

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 (FMT) in combination with neoadjuvant anthracycline-based chemotherapy for invasive (T2, T3) breast cancer. (5) Compared with 13 patients who received only the anthracycline-based regimen, there was greater (88% verses 59%) tumor volume reduction in the experimental group. Furthermore, Dooley and colleagues (6) 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. (7) reviewed the results of 4 multi-institutional clinical studies of preoperative FMT 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 (8) 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.

Clinical Trials

The following randomized clinical trials were noted:

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. No further study details are currently available. The last update noted was November 2013. (9)

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. This study is ongoing, but not actively recruiting participants. There is no estimated date of completion. (10)

Practice Guidelines and Position Statements

The American College of Radiology (ACR)

The 2012 ACR updated in 2016, 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. (11)

National Comprehensive Cancer Network (NCCN)

The NCCN does not address microwave thermotherapy in the April 2017 Clinical Practice Guideline on Breast Cancer. (12)

Summary of Evidence

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.

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:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

19499, 0301T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

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

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

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

References:

1. FDA 510(k) summary: Tri-Loop™ Microwave Ablation Probe (K032047). Available at <http://www.accessdata.fda.gov> (accessed - 2017 August 25).

2. FDA 510(k) summary: Viva Wave™ Microwave Ablation System (K053535). Available at <http://www.accessdata.fda.gov> (accessed - 2017 August 25).

3. Gardner RA, Vargas HI, Block JB, et al. Focused microwave phased array thermotherapy for primary breast cancer. Ann Surg Oncol. May 2002; 9(4):326-32. PMID 11986183

4. 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. Feb 2004; 11(2):139-46. PMID 14761916

5. 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.

6. 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.

7. Dooley WC, Vargas HI, et al. Focused microwave thermotherapy for preoperative treatment of invasive breast cancer: a review of clinical studies. Ann Surg Oncol. Apr 2010; 17(4):1076-93. PMID 20033319

8. Zhao Z and F. Wu. Minimally-invasive thermal ablation of early-stage breast cancer: a systemic review. Eur J Surg Oncol. Dec 2010; 36(12):1149-55. PMID 20889281

9. Breast Cancer Trial. Microwave thermography in treating women with stage I or stage II breast cancer. Available at < http://www.clinicaltrials.gov> (accessed - 2017 August 18). Trial 10200202.

10. Breast Cancer Trial. Combination chemotherapy with or without microwave thermotherapy before surgery in treating women with locally advanced breast cancer. Available at <http://www.clinicaltrials.gov> (accessed - 2017 August 18). Trial 10200201.

11. American College of Radiology (ACR). CR appropriateness criteria. Breast Cancer Screening. 2012 (Updated 2016). Available at: < http://www.acr.org> (accessed - 2017 August 26).

12. National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology. Breast Cancer. V2.2017. Available at < http://www.nccn.org> (accessed - 2017 August 26).

13. Microwave Thermotherapy for Primary Breast Cancer (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 January) Medicine 2.03.06.

Policy History:

Date Reason
9/14/2019 Document became inactive.
7/15/2018 Reviewed. No changes.
10/15/2017 Document updated with literature review. Coverage unchanged.
7/1/2016 Document updated with literature review. Coverage unchanged.
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

Archived Document(s):

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