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| |  IBCC: Microwave Therapy Improves Chance Of Saving Breast By Robert H. Carlson Special to DG News MIAMI, FL -- March 3, 2002 -- Microwave thermotherapy may offer breast-cancer patients a better chance of conserving their breast by shrinking tumors substantially before they undergo surgery. The experimental therapy was described in a presentation here at the 19th Annual International Breast Cancer Conference. "Breast conservation surgery as the initial treatment of breast cancer is not applicable to patients with large tumors," said Robert A. Gardner, MD, a breast cancer specialist at the Center for Breast Surgery, West Palm Beach, Florida, and principal investigator in a phase-I safety trial and an ongoing phase-II efficacy trial of focused microwave thermotherapy. "And breast-conservation surgery can causes suboptimal breast cosmetic outcomes in women with median size tumors or with small breasts." By shrinking tumors substantially before surgery, a woman might be eligible for a breast-conserving lumpectomy instead of a radical mastectomy. Focused microwave phased-array thermotherapy (FMPA) is a minimally invasive procedure designed to preferentially heat and kill breast tumors and microscopic cancer cells without causing skin damage. As the patient lies prone on the treatment table, a microwave needle is inserted through the skin and into the tumor, guided by ultrasound, much as a biopsy probe would be directed. During treatment, 915 MHz of microwave energy generated outside the breast is focused onto the tip of the needle, heating the tumor but not overheating the surrounding healthy tissue. Temperature-probe needles monitor tumor and skin temperatures. In a phase-I trial testing the procedure’s safety, 10 patients with tumors ranging in clinical size from 1 to 8 cm were treated with microwave thermotherapy for a mean of 52 minutes prior to scheduled mastectomy. Dr. Gardner said side effects were one skin blister and three early cases of skin flap necrosis. He said six of the 10 tumors were reduced a median of 41 percent in size. Post-mastectomy pathology showed four of the 10 patients had ischemic tumor necrosis of 40 to 60 percent. Seven patients have already been treated in the phase-II study, which has two trial protocols, Dr. Gardner said. In the first study, 43 women with early-stage disease will be treated with microwave thermotherapy (46 degrees C.) prior to lumpectomy. The object is to measure the thermal cell kill in the postoperative pathologic analyses. The second phase-II protocol will determine whether thermotherapy plus pre-surgical (neoadjuvant) chemotherapy improves a woman’s chances of undergoing lumpectomy instead of mastectomy, compared with chemotherapy alone. Dr. Gardner cited numerous laboratory and animal studies that showed heat treatment enhances the activity of Adriamycin (doxorubicin). Ninety patients with locally advanced breast cancer, who would typically receive mastectomy, will first have microwave therapy (43 to 44 degrees C for 100 minutes) plus four cycles of neoadjuvant AC chemotherapy (Adriamycin plus Cytoxan [cyclophosphamide]). The 40 women in the control group will receive AC chemotherapy alone. The 130 women will then either undergo mastectomy or breast-conserving lumpectomy depending on how much the pre-surgical therapy has shrunk the tumor. "Currently, neoadjuvant chemotherapy can only convert about 30 to 40 percent of patients from mastectomy to breast conservation therapy," Dr. Gardner said. Sponsor of the phase-I and -II trials is Celsion, Columbia, Maryland, manufacturer of the microwave thermotherapy system.
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