Gemcitabine/Capecitabine in Patients with Metastatic Breast Cancer Pretreated with Anthracyclines and Taxanes

• Published in: Clinical breast cancer Vol. 6; no. 2; pp. 158 - 162
• Main Authors: Andres, Beth, Mayordomo, Jose Ignacio, Lara, Ricardo, Lastra, Rodrigo, Ortega, Eugenia, Polo, Eduardo, Lambea, Julio, Isla, Dolores, Saenz-Cusi, Alberto, Escudero, Pilar, Tres, Alejandro
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2005
• Subjects: Adult; Aged; Anthracyclines - pharmacology; Anthracyclines - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Capecitabine; Combination therapy; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease Progression; Drug Resistance, Neoplasm; Female; Fluorouracil - analogs & derivatives; Hand-foot syndrome; Humans; Infusions, Intravenous; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Pyridoxine; Pyrimidine; Taxoids - pharmacology; Taxoids - therapeutic use; Treatment Outcome; Pyridoxine; Combination therapy; Hand-foot syndrome; Pyrimidine
• ISSN: 1526-8209; 1938-0666
• DOI: 10.3816/CBC.2005.n.018

Gemcitabine and capecitabine are 2 anticancer drugs with a mechanism of action involving metabolism of pyrimidine nucleotides. Both are among the few agents active in patients with metastatic breast cancer (MBC) progressing after therapy with anthracyclines and taxanes. We have conducted a phase II trial of gemcitabine/capecitabine in patients with disease progression after treatment with anthracyclines and taxanes. Treatment included gemcitabine 2000 mg/m 2 on day 1 every 3 weeks and capecitabine 2500 mg/m 2 daily (divided into 2 doses) on days 1–14 every 3 weeks; treament was administered until disease progression or unacceptable toxicity was documented. All patients received concomitant oral pyridoxine 300 mg twice daily to prevent hand-foot syndrome (HFS). Of 39 patients treated, 33 had received previous treatment with anthracyclines, 6 had medical contraindication to anthracyclines, 35 had previously received taxanes, and 23 had received vinorelbine. Fourteen patients had previous high-dose chemotherapy with stem cell rescue and 5 had previously received trastuzumab. Patients were 31–79 years of age (median, 55 years) and, altogether, were given 386 courses of therapy (range, 1–36 courses per patient; median, 6 courses). Grade 3/4 toxicities included HFS (11 courses, 6 patients), stomatitis (6 courses, 2 patients), diarrhea (5 courses, 4 patients), anemia (5 courses, 2 patients), thrombocytopenia (5 courses, 2 patients), and neutropenia (1 course, 1 patient). Response rate (all 39 patients were evaluable) was 48.7% (partial response, n = 19; stable disease, n = 7; progressive disease, n = 13). Thirty-six patients died because of disease progression, and 3 are alive with progressive disease. Median follow-up was 26 months or until death. Median duration of response was 15 months (range, 3–26 months). Median time to disease progression was 5 months (range, 1–26 months). Median overall survival duration was 10 months (range, 1–37 months). In this cohort of patients heavily pretreated with anthracyclines and taxanes, the response rate to gemcitabine/capecitabine is encouraging, although response duration is limited.