Single-agent Capecitabine in Patients with Metastatic Colorectal Cancer Refractory to 5-Fluorouracil/Leucovorin Chemotherapy

• Published in: Japanese journal of clinical oncology 2004-07, Vol.34 (7), p.400-404
• Main Authors: Lee, Jae Jin, Kim, Tae Min, Yu, Su Jong, Kim, Dong-Wan, Joh, Yo-han, Oh, Do-Youn, Kwon, Jung Hye, Kim, Tae You, Heo, Dae Seog, Bang, Yung-Jue, Kim, Noe Kyeong
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Administration, Oral; Adult; Aged; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - adverse effects; Antimetabolites, Antineoplastic - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Capecitabine; Colorectal cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - pathology; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease Progression; Drug Resistance, Neoplasm; Female; Fluorouracil - administration & dosage; Humans; Key words: capecitabine – metastatic colorectal – cancer – second-line chemotherapy; Leucovorin - administration & dosage; Male; Middle Aged; Neoplasm Metastasis; Peripheral Nervous System Diseases - chemically induced; Treatment Outcome
• ISSN: 0368-2811; 1465-3621
• DOI: 10.1093/jjco/hyh068

Objective: The effectiveness of capecitabine, an oral fluoropyrimidine carbamate, is well documented in previously untreated metastatic colorectal cancer patients (overall response rate: 25%). However, its efficacy in patients with metastatic colorectal cancer refractory to 5-fluorouracil/leucovorin (5-FU/LV) has not been determined. This study was performed to evaluate the efficacy and to identify the side-effects of capecitabine in patients with metastatic colorectal cancer showing progression despite 5-FU/LV-based combination chemotherapy. Methods: Fifty-one metastatic colorectal cancer patients who showed progressive disease in 5-FU/LV-containing regimens (median: two regimes) were treated with capecitabine 1250 mg/m2 twice daily (days 1–14 repeated every 3 weeks). Results: Only one partial response was observed (response rate: 2%). Twenty-seven patients (53%) showed stable disease after two cycles. The median time to disease progression of either a partial response or stable disease was 3.4 months. Hand–foot syndrome was the main toxicity of capecitabine and occurred in 35% of cases (grade 3 or 4 in 6%). The median number of cycles administered was two and the relative dose intensity of capecitabine was 80%. Conclusion: The response rate to capecitabine was low in metastatic colorectal cancers that were refractory to 5-FU/LV-containing chemotherapy. However, disease stabilization was seen in a significant number of patients.