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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 F .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 F .0001). Overall, quality of life was similar for both treatments (P H .07).Conclusion IN THE UNITED STATES each year, more than 180,000 women are diagnosed with breast cancer and more than 45,000 die of the disease. 1 Despite the major advances in adjuvant therapy, metastatic breast cancer remains a major clinical problem that affects large numbers of patients. For many years, standard chemotherapy combinations have been the mainstay of therapy for metastatic disease that is hormone resistant, estrogen receptor-negative, or with lifethreatening or visceral disease. Initial chemotherapy has been either combinations of cyclophosphamide, methotrexate, fluorouracil, and prednisone (CMFP) followed by anthracycline, or doxorubicin-containing combinations. [2][3][4] The choice of an appropriate initial chemotherapy is often limited by early relapse in patients who recently received adjuvant chemotherapy with the same combinations or by the condition of the patient. Thus, it is important to define the place of new anticancer drugs in breast cancer therapy.When first described by Cooper, 5 CMFP-like combinations were reported with high response rates. When assessed using modern criteria and increasingly sophisticated imaging procedures, the CMFP regimen with or without vincristine produced objective responses in 37% to 68% of patients and median durations of response ranging from 6 to 11 months, with an associated median survival duration from initiation of treatment of 7 to 16 months. [6][7][8][9][10][11][12][13][14][15] Doxorubicin alone has been shown to be as active as CMFP combinations in randomized studies in advanced breast cancer. 2,8,16 In these studies, doxorubicin produced shorter response duration when used as a single agent, but there was no clear difference in survival. Survival is difficult to interpret in these studies because patients were usually crossed over to the alternative regimen on progression.Of six randomized studies that compared combinations of cyclophosphamide, doxorubicin, and fluorouracil with CMFP combinations in advanced breast cancer, three showed significantly higher response rates with the combination of cyclophosphamide, doxorubicin, and fluorouracil. [17][18][19][20][21][22][23] However, only two of six studies showed a statistically significant survival advantage for the doxorubicin combination. These studies have bee...