Capecitabine Plus Paclitaxel As Front-Line Combination Therapy for Metastatic Breast Cancer: A Multicenter Phase II Study

• Published in: Journal of clinical oncology Vol. 22; no. 12; pp. 2321 - 2327
• Main Authors: GRADISHAR, William J, MEZA, Luis A, AMIN, Bipinkumar, SAMID, Dvorit, HILL, Todd, CHEN, Yin-Miao, LOWER, Elyse E, MARCOM, P. Kelly
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 15.06.2004; Lippincott Williams & Wilkins
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Capecitabine; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease Progression; Female; Fluorouracil - analogs & derivatives; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Medical sciences; Middle Aged; Neoplasm Recurrence, Local; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel - therapeutic use; Survival Analysis; Time Factors; Treatment Outcome; Tumors; Antineoplastic agent; Drug combination; Capecitabine; Multicenter study; Breast cancer; Metastasis; Malignant tumor; Mammary gland diseases; Taxane derivatives; Phase II trial; Paclitaxel; Metastatic; Combined treatment; Mammary gland; Pyrimidine nucleoside; Antimitotic
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2004.12.128

The goal of this multicenter, open-label phase II study was the clinical evaluation of combination therapy with the oral fluoropyrimidine capecitabine and the taxane paclitaxel in patients with metastatic breast cancer (MBC). Forty-seven patients with MBC received oral capecitabine at 1650 mg/m(2)/d (825 mg/m(2) twice daily) on days 1 through 14, and intravenous infusion of paclitaxel at 175 mg/m(2) on day 1 of each 21-day treatment cycle. Treatment continued until disease progression, intolerable toxicity, or patient' s decision to discontinue. Patients (35 to 76 years old) had a median Karnofsky performance status of 90%. Forty-four patients (94%) received study treatment as first-line therapy for metastatic disease. Objective responses occurred in 24 (51%) patients; seven (15%) complete responses and 17 (36%) partial responses. Stable disease lasting 180 days or more was observed in nine (19%); the clinical response rate was 70%. Median duration of response was 12.6 months, median time to disease progression was 10.6 months, and median overall survival time was 29.9 months. The most common treatment-related adverse events, regardless of severity, were alopecia, hand-foot syndrome, nausea, and fatigue. Neutropenia (15%), alopecia (13%), and hand-foot syndrome (11%) were the only grade 3 or 4 treatment-related adverse events that occurred in more than 10% of patients. The combination of capecitabine plus paclitaxel is a highly active and generally well-tolerated regimen for first-line treatment of MBC.