Archived Policies - Surgery


Microwave Thermotherapy for Primary Breast Cancer

Number:SUR701.020

Effective Date:08-15-2009

End Date:09-14-2011

Coverage:

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

Description:

Focused microwave phase array thermotherapy has been investigated as a type of heat therapy for either treating 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).

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 ten patients that reported that the technique is technically feasible. The following randomized clinical trials are now ongoing:

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.

A search of the literature was performed through August 2007.  No additional studies were identified that would prompt a reconsideration of the coverage position, which remains unchanged.

2009 Update

The policy was updated with a search of peer reviewed literature through through June 2009.  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.  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 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.

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:

The specific CPT code, 0061T was deleted 1/1/2009 and was not replaced.  An unlisted code might be used for billing.


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 or changed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

Gardner, R.A., Vargas, H.I., et al.  Focused microwave phased array thermotherapy for primary breast cancer.  Annals of Surgical Oncology (2002 May) 9(4):326-32.

Celsion News Release – Breast Cancer 2004.  Celsion’s News Releases (2004 November 10). Available at <http://www.celsion.com>.

Vargas, H.I., Dooley, W.C., Gardner, R.A. et al.  Focused microwave phased array thermotherapy for ablation of early-stage breast cancer: results of thermal dose escalation.  Annals of Surgical Oncology (2004) 11(2):139-46.  Available at <http://www.celsion.com>.

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 <http://www.cancer-therapy.org>.

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 <http://www.cancer-therapy.org>.

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

Policy History:

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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