Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer

Purpose: To determine the place of single-agent paclitaxel compared with nonanthracycline combination chemotherapy as front-line therapy in metastatic breast cancer. Patients and Methods: patients with previously untreated metastatic breast cancer were randomized to receive either paclitaxel 200 mg/m(2) intravenously (IV) over 3 hours for eight cycles (24 weeks) or standard cyclophosphamide 100 mg/m(2)/d orally on days 1 to 14, methotrexate 40 mg/m(2) IV on days 1 and 8, fluorouracil 600 mg/m(2) IV on days 1 and 8, and prednisone 40 mg/m2/d orally on days 1 to 14 (CMFP) for six cycles (24 weeks) with epirubicin recommended as second-line therapy. Results: A total of 209 eligible patients were randomized with a median survival duration of 17.3 months for paclitaxel and 13.9 months for CMFP. Multivariate analysis showed that patients who received paclitaxel survived significantly longer than those who received CMFP (P = .025). Paclitaxel produced significantly less severe leukopenia, thrombocytopenia, mucositis, documented infections (all P < .001), nausea or vomiting (P = .003), and fever without documented infection (P = .007), and less hospitalization for febrile neutropenia than did CMFP (P = .001). Alopecia, peripheral neuropathy, and myalgia or arthralgia were more severe with paclitaxel (all P < .0001). Overall, quality of life was similar for both treatments (P greater than or equal to .07). Conclusion: Initial paclitaxel was associated with significantly less myelosuppression and fewer infections, with longer survival and similar quality of life and control of metastatic breast cancer compared with CMFP. (C) 1999 by American Society of Clinical Oncology.