Abstract
This randomized, multicenter, phase III trial evaluated whether sequential doxorubicin and docetaxel (A3 T) reduced hematological toxicity, especially febrile neutropenia, compared with concomitant (AT) administration as first-line chemotherapy in metastatic breast cancer (MBC). One hundred forty-four patients were randomly assigned to receive three cycles of doxorubicin 75 mg/m 2 every 21 days followed by three cycles of docetaxel 100 mg/m 2 , every 21 days (A3 T) or six cycles of the combination doxorubicin 50 mg/m 2 and docetaxel 75 mg/m 2 (AT) every 21 days. Patients previously treated with anthracyclines received two cycles of doxorubicin followed by four cycles of docetaxel (A3 T), or three cycles of AT followed by three cycles of docetaxel 100 mg/m 2 every 21 days. Febrile neutropenia was less common in the A3T arm (29.3% of patients, 6.9% of cycles) compared with the AT arm (47.8% of patients, 14.8% of cycles; P ϭ .02 and P ϭ .0004, respectively). Asthenia, diarrhea, and fever occurred more frequently in the AT arm. The overall responses rates were 61% in the A3T arm (95% CI, 50% to 72%) and 51% in the AT arm (95% CI, 39% to 63%). The median duration of response was 8.7 months (A3T) and 7.6 months (AT); the median time to progression was 10.5 months (A3T) and 9.2 months (AT); the median overall survival was 22.3 months (A3T) and 21.8 months (AT); and no significant differences were found. A3T significantly reduced febrile neutropenia compared with AT in MBC patients and maintains comparable antitumoral efficacy. A3T represents a valid option for the treatment of MBC.
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