Phase II trial of doxorubicin and docetaxel plus granulocyte colony- stimulating factor in metastatic breast cancer: Eastern Cooperative Oncology Group Study E1196

Joseph A. Sparano, Anne O'Neill, Paul L. Schaefer, Carla I. Falkson, William C. Wood

Research output: Contribution to journalArticle

82 Scopus citations


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 I 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 justify a phase III comparison with doxorubicin-cyclophosphamide in early-stage breast cancer. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish (US)
Pages (from-to)2369-2377
Number of pages9
JournalJournal of Clinical Oncology
Issue number12
Publication statusPublished - Jun 2000
Externally publishedYes


ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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