|MP 2.03.06||(Archived) Microwave Thermotherapy for Primary Breast Cancer|
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Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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).
Focused microwave phase array thermotherapy is considered investigational as a treatment of breast cancer.
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.) (code discontinued as of 12/31/08) Use 19499: Unlisted procedure, breast
BlueCard/National Account Issues
The use of microwave thermotherapy as a treatment of breast cancer is limited to those institutions participating in the IDE trials. Therefore, patients seeking this treatment may request out of network referral. Participating institutions include:
University of Oklahoma, Oklahoma City, OK
The Center for Breast Surgery in West Palm Beach, FL
UCSR-East Bay Campus, Oakland, CA
Mroz-Baier Breast Care Center, Memphis TN
Harbor-UCLA Medical Center, Torrance, CA
Comprehensive Breast Center of Coral Springs, Coral Springs, FL
Pearl Place, Tacoma, WA
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. (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) The following randomized clinical trials are now ongoing (3):
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.
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 for the period of 2005. No additional studies were identified that would prompt a reconsideration of the policy statement, which remains unchanged.
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. (4) In addition, this device still does not have clearance or approval from the FDA. Thus, the policy statement is unchanged.
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. (5) 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. (6) 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 policy statement. Studies involving larger numbers of patients with longer follow-up of clinical outcomes are needed.
- 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.
- 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.
- www.celsion.com/products/trials.cfm (accessed 12/19/2007)
- 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/vol5b.pdf
- 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/vol6b.pdf
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, 76998) (discontinued 12/31/08)
|19499||Unlisted procedure, breast|
Malignant neoplasm of the female breast
Breast Cancer, Microwave Thermotherapy
Microwave Thermotherapy, Breast Cancer
|10/9/03||Add policy to Medicine section, Oncology subsection||New policy|
|04/1/05||Replace policy||Policy updated; reference number 2 added; no change in policy statement; still considered investigational|
|03/7/06||Replace policy||Policy updated; no change in policy statement; still considered investigational|
|01/10/08||Replace policy||Policy updated with literature search; no change in policy statement. Reference number 4 added.|
|01/08/09||Replace policy||Policy updated with literature search; no change in policy statement.|