Medicine Section - Microwave Thermotherapy for Primary Breast Cancer

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PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

Description

Focused microwave phase array thermotherapy is a technique for exposing tissues to high temperatures to damage or destroy cancer cells or to make cancer cells more sensitive to radiation therapy or certain anticancer drugs.  In microwave heating, the higher the water content in tissues, the higher the temperature that may be achieved.  Since breast cancer cells have a higher water content than the surrounding healthy breast tissues, the cancer cells can be exposed to high temperatures without harming the surrounding normal tissues.

Microwave technology has been investigated in the treatment of breast cancer in the following circumstances:

• In conjunction with lumpectomy in patients with early stage breast cancer
• In conjunction with preoperative chemotherapy to reduce the size of the tumor in patients with advanced breast cancer

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).

Policy/Criteria

Focused microwave phase array thermotherapy is considered investigational as a treatment of breast cancer.

Position Summary

Effectiveness

It is unknown whether microwave thermotherapy improves survival rates or decreases or delays breast cancer recurrence.

Clinical trial data is limited to small case series (2,3) and two small randomized trials, summarized below. Studies involving larger numbers of patients with longer follow-up of clinical outcomes are needed.

Vargas and colleagues randomized patients with invasive (T2, T3) breast cancer to receive either preoperative focused-microwave thermotherapy in combination with neoadjuvant anthracycline-based chemotherapy (n=15) or a control group that received anthracycline-based regimen alone (n=13). (4) There was greater tumor volume reduction in the experimental group compared to the control group (88% vs. 59%, respectively).

Dooley and colleagues randomized early breast cancer patients to either a control group who received surgery only (n=41), or an experimental group who received thermotherapy prior to surgery (n=34). (5) Although there were fewer positive margins in the experimental group than in the control group [0% (0 of 34) and 10%, respectively], the difference did not reach statistical significance (p=0.13).

Safety

Safety and complication rates are also unknown due to the lack of clinical trial data noted above.

Clinical trials currently in progress

The following randomized clinical trials are ongoing but are no longer recruiting patients:

Study 102-00-202 (NCT00036998)

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. (6) 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 (NCT00036985)

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. (7) The primary endpoints include downsizing from mastectomy to partial mastectomy, and determining the percentage of patients with ≥85% pathological cell death.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 2.03.06
2. 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
3. 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
4. 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
5. 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
6. http://www.clinicaltrials.gov/ct2/show/NCT00036998?term=00036998&rank =1  (Verified 5/15/09)
7. http://www.clinicaltrials.gov/ct2/show/NCT00036985?term=00036985&rank =1  (Verified 5/15/09)

Cross References

None

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