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American Society of Clinical Oncology 35th Annual
Meeting
Day 2 - May 16,
1999
Edith A. Perez, MD -- Writer: Michelle L. Plante, PharmD
Three small clinical trials on induction chemotherapy pointed to a potentially increasing role for taxanes in patients with resectable breast cancer.
The study was divided into 2 phases. In the first, all patients received 4 cycles of CVAP (cyclophosphamide 1000 mg/m2, vincristine 1.5 mg/m2 {max 2mg}, doxorubicin 50mg/m2, prednisone 40 mg/day x 5 days, every 21 days) and were evaluated for response. Based on the results, the investigators decided what phase 2 therapy the patient would receive. Patients who did not respond to the CVAP therapy received 4 cycles of docetaxel 100mg/m2. Patients who achieved a complete or partial response to the initial therapy were randomized to receive either 4 more cycles of the same chemotherapy or 4 cycles of docetaxel 100mg/m2.
To date, 148 patients with large (>/=3cm) or T2N3 tumors have been enrolled. Of those, 69% achieved an objective response to the first 4 cycles of CVAP. One-hundred thirty-three patients went on to phase 2 (93 patients with a response to the initial CAVP therapy to the randomization arm and 40 to the docetaxel arm). Of the patients randomized to either CVAP or docetaxel, the objective response rate was significantly improved when patients received docetaxel as shown in Table I.
Table I. Responses rates of patients who responded to initial CAVP therapy and then were randomized to CVAP or docetaxel therapy.
Response CVAP
n = 48Docetaxel
n = 45Complete response 36% 60% Partial response 31% 36% Stable disease 29% 4% Progressive disease 4% 0% Overall response 67% 96%* * p = 0.001
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