TY - JOUR
T1 - Phase II trial of doxorubicin and docetaxel plus granulocyte colony- stimulating factor in metastatic breast cancer
T2 - Eastern Cooperative Oncology Group Study E1196
AU - Sparano, Joseph A.
AU - O'Neill, Anne
AU - Schaefer, Paul L.
AU - Falkson, Carla I.
AU - Wood, William C.
PY - 2000/6
Y1 - 2000/6
N2 - 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.
AB - 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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U2 - 10.1200/JCO.2000.18.12.2369
DO - 10.1200/JCO.2000.18.12.2369
M3 - Article
C2 - 10856096
AN - SCOPUS:0034053684
SN - 0732-183X
VL - 18
SP - 2369
EP - 2377
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 12
ER -