Prospective evaluation of paclitaxel versus combination chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with operable breast cancer

Purpose: To compare prospectively the antitumor activity of single-agent pa clitaxel to the three-drug combination of fluorouracil, doxorubicin, and cy clophosphamide (FAC) as neoadjuvant therapy in patients with operable breas t cancer. Patients and Methods: Patients with T1-3N0-1M0 disease were randomized to r eceive either paclitaxel (250 mg/m(2)) as 24-hour infusion or FAC in standa rd doses at every-3-week intervals. Each patient was treated with four cycl es of preoperative chemotherapy. Clinical response and extent of residual d isease in the breast and lymph nodes war assessed after four cycles of indu ction chemotherapy. Results: A total of 174 patients were registered, and 87 were randomized to each arm of the study Clinical response, ie, complete and partial response s, was similar in both arms of the study. Three patients in the PAC arm and one patient in the paclitaxel subgroup had progressive disease. The extent of residual disease by intent-to-treat analysis at the time of surgery was similar between the two arms of the study. Conclusion: The results of this prospective study demonstrated that single- agent paclitaxel as neoadjuvant therapy has significant antitumor activity, and this was clinically comparable to FAC. Similar fractions of patients h ad clinical complete and partial responses, and very few patients had no re sponse to either therapy. The value of alternate non-cross-resistant therap ies as used in this protocol on the clinical course of this disease would r equire longer follow-up. (C) 1999 by American Society of Clinical Oncology.