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Phase II Trial of Doxorubicin and Docetaxel Plus Granulocyte Colony-Stimulating Factor in Metastatic Breast Cancer: Eastern Cooperative Oncology Group Study E1196

From the Albert Einstein Comprehensive Cancer Center, Montefiore Medical Center, Bronx, NY; Dana-Farber Cancer Institute, Boston, MA; Toledo Hospital, Toledo, OH; University of Pretoria, Pretoria, South Africa; and Emory University School of Medicine, Atlanta, GA.

Address reprint requests to Joseph A. Sparano, MD, Albert Einstein Comprehensive Cancer Center, Montefiore Medical Center, Department of Oncology-2South, Room 52, 1825 Eastchester Rd, Bronx, NY 10461-2373.

PURPOSE: The purpose of this multi-institutional phase II trial was to evaluate the efficacy and toxicity of doxorubicin and docetaxel plus granulocyte colony-stimulating factor (G-CSF) in patients with metastatic breast cancer. The primary objective was to determine whether the combination produced a response rate of at least 50%.

PATIENTS AND METHODS: Fifty-four patients with metastatic breast cancer received doxorubicin (60 mg/m² by intravenous [IV] injection) followed 1 hour later by docetaxel (60 mg/m² by IV infusion over 1 hour) every 3 weeks for up to eight cycles. All patients also received G-CSF.

RESULTS: Objective response occurred in 29 (57%) of 51 eligible patients (95% confidence interval [CI], 42% to 70%), including three patients who had a complete response (6%; 95% CI, 1% to 16%). The median response duration was 7 months (95% CI, 6.0 to 15.0 months), median time to treatment failure was 7.6 months (95% CI, 6.2 to 9.9 months), and the median survival was 27.5 months (95% CI, 21.5 months to upper limit not reached). The median cumulative doxorubicin dose was 395 mg/m² (range, 60 to 480 mg/m²). Fifteen patients (28%) were documented to have a decrease in the left ventricular ejection fraction below normal, and three patients (6%; 95% CI, 1% to 15%) developed congestive heart failure.

CONCLUSION: Using criteria that we had defined a priori, the doxorubicin-docetaxel regimen as used in this study was sufficiently active and tolerable to justify a phase III comparison with doxorubicin-cyclophosphamide in early-stage breast cancer.

Presented at the Twenty-First Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 15, 1998.

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