Trial Combining Taxol and Radiation Therapy for Treatment of Locally Advanced Breast Cancer. Phase 1.
Abstract
Patients with locally advanced breast cancer, which represents less than 5% of annually diagnosed breast cancer cases, are a very heterogeneous group of patients. The optimal management of these patients remains controversial. Several randomized and nonrandomized clinical trials demonstrate a benefit in the use of chemotherapy combined with local treatment (surgery and/or radiation therapy) for these patients with prolongation of both disease free and overall survival. Given the ability of radiation therapy to control local disease and the failure of conventional chemotherapy to provide long lasting control of distant disease, combining paclitaxel with radiation therapy seems worthy of investigation. We have shown in tissue culture a supraadditive interaction between this drug and radiation. In our clinical trial, patients received six weekly 3-hour infusions of paclitaxel during preoperative radiation therapy, followed by modified radical mastectomy when possible. All patients received adjuvant CAF chemotherapy. To date, we have enrolled six patients; three patients at 25 mg/M2, and three patients at 33 mg/M2 paclitaxel. No unexpected adverse reactions were observed in the first six patients. Three of six patients obtained a clinical complete response prior to surgery, two patients had a partial response, and one patient progressed. All patients had a mastectomy with a pathologic response remarkable for residual microscopic disease in those patients who had clinical complete responses. Two patients are dead of disease, three patients are free of disease, and one is alive, but clinical status is unknown. Pharmacokinetic studies revealed levels of drug present in serum 4-72 hours after infusion in the radiation sensitizing range observed in tissue culture. Needle aspirations of tumors during chemoradiation were obtained.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1996
- Accession Number
- ADA323556
Entities
People
- Peter B. Schiff
Organizations
- Columbia University