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

From the Albert Einstein Comprehensive Cancer Center, Montefiore Medical Center, Bronx, NY; Dana-Farber Cancer Institute, Boston, MA; Siouxland Hematology Oncology Association, Sioux City, IA; 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–2 South, Room 52, 1825 Eastchester Rd, Bronx, NY 10461-2373; email sparano{at}jimmy.harvard.edu

PURPOSE: Several groups have reported that the combination of doxorubicin plus 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% incidence of congestive heart failure (CHF). The purpose of this phase II trial was to evaluate the antineoplastic activity of the regimen in a multi-institutional setting and to reduce the incidence of cardiotoxicity by limiting treatment to a maximum of six cycles.

PATIENTS AND METHODS: Fifty-two patients with advanced breast cancer received doxorubicin (60 mg/m² by IV injection) followed 15 minutes later by paclitaxel (200 mg/m² by IV infusion over 3 hours) every 3 weeks for four to six cycles.

RESULTS: Objective responses occurred in 25 of 48 assessable patients (52%; 95% confidence interval [CI], 38% to 66%), including four complete responses (8%; 95% CI, 0% to 16%). The median cumulative doxorubicin dose given was 240 mg/m² (range, 132 to 360 mg/m²). Eleven patients (21%) were documented as having a decrease in the LVEF below normal, including three patients (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 proved to be excessively cardiotoxic for use in the adjuvant setting.

Conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Group Chair) and supported in part by Public Health Service grants no. CA21076, CA23318, CA21692, and CA21115 from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services, Bethesda, MD.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Presented at the 20th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 5, 1997.

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