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Japanese Journal of Clinical Oncology 2004 34(7):400-404; doi:10.1093/jjco/hyh068
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© 2004 Foundation for Promotion of Cancer Research

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

Jae Jin Lee, Tae Min Kim, Su Jong Yu, Dong-Wan Kim, Yo-han Joh, Do-Youn Oh, Jung Hye Kwon, Tae You Kim, Dae Seog Heo, Yung-Jue Bang and Noe Kyeong Kim+

Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

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.

+ For reprints and all correspondence: Dae Seog Heo, Department of Internal Medicine, Seoul National University College of Medicine, 28 Yongon-dong, Chongno-gu, Seoul, 110-744, Korea. E-mail: heo1013{at}plaza.snu.ac.kr


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