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

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Abstract

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
Volume18
Issue number12
StatePublished - Jun 2000
Externally publishedYes

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docetaxel
Granulocyte Colony-Stimulating Factor
Doxorubicin
Breast Neoplasms
Confidence Intervals
Treatment Failure
Intravenous Infusions
Intravenous Injections
Stroke Volume
Cyclophosphamide

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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

In: Journal of Clinical Oncology, Vol. 18, No. 12, 06.2000, p. 2369-2377.

Research output: Contribution to journalArticle

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abstract = "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.",
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