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

• Published in: Journal of clinical oncology Vol. 18; no. 12; pp. 2369 - 2377
• Main Authors: SPARANO, J. A, O'NEILL, A, SCHAEFER, P. L, FALKSON, C. I, WOOD, W. C
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 12-06-2000; Lippincott Williams & Wilkins
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Chemotherapy; Doxorubicin - administration & dosage; Drug Administration Schedule; Female; Granulocyte Colony-Stimulating Factor - administration & dosage; Humans; Infusions, Intravenous; Injections, Intravenous; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Paclitaxel - analogs & derivatives; Pharmacology. Drug treatments; Survival Analysis; Taxoids; Treatment Outcome; Human; Antineoplastic agent; Drug combination; Carcinoma; Cytokine; Docetaxel; Malignant tumor; Doxorubicin; Mammary gland diseases; Chemotherapy; Granulocyte colony stimulating factor; Polypeptide; Taxane derivatives; Phase II trial; Adult; Anthracyclins; Metastatic; Combined treatment; Mammary gland
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2000.18.12.2369

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%.
Fifty-four patients with metastatic breast cancer received doxorubicin (60 mg/m(2) by intravenous [IV] injection) followed 1 hour later by docetaxel (60 mg/m(2) by IV infusion over 1 hour) every 3 weeks for up to eight cycles. All patients also received G-CSF.
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/m(2) (range, 60 to 480 mg/m(2)). 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.
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.