Phase II trial of doxorubicin and paclitaxel plus granulocyte colony-stimulating factor in metastatic breast cancer: An eastern cooperative oncology group study

Purpose: Several groups have reported that the combination of doxorubicin p lus paclitaxel given as a 3-hour intravenous (IV) infusion for up to eight cycles produces a high response rate (> 80%) and complete response rate (> 20%) in metastatic breast cancer, but is also complicated by a 20% incidenc e of congestive heart failure [CHF). The purpose of this phase Il trial was to evaluate the antineoplastic activity of the regimen in a multi-institut ional setting and to reduce the incidence of cardiotoxicity by limiting tre atment to a maximum of six cycles. Patients and Methods: Fifty-two patients with advanced breast cancer receiv ed doxorubicin (60 mg/m(2) by IV injection) followed 15 minutes later by pa clitaxel (200 mg/m(2) by IV infusion over 3 hours) every 3 weeks for four t o six cycles. Results: Objective responses occurred in 25 of 48 assessable patients (52%; 95% confidence interval [CI], 38% to 66%), including four complete respons es (8%; 95% CI, 0% to 16%), The median cumulative doxorubicin dose given wa s 240 mg/m(2) (range, 132 to 360 mg/m(2)). Eleven patients (21%) were docum ented as having a decrease in the LVEF below normal, including three patien ts (6%; 95% CI, 0% to 12%) who developed CHF, Conclusion: The doxorubicin/paclitaxel regimen that we used is unlikely to produce an objective response rate of more than 70% and a complete response rate of more than 20% in patients with metastatic breast cancer, and prove d to be excessively cardiotoxic for use in the adjuvant setting. J Clin Onc ol 11:3828-3834, (C) 1999 by American Society of Clinical Oncology.