Abstract

There has been limited data on capecitabine monotherapy in metastatic colorectal cancer (CRC) patients who were previously treated with both oxaliplatin/5-fluorouracil(FU)/leucovorin (FOLFOX) and irinotecan/5-FU/leucovorin (FOLFIRI). We analyzed 20 patients between August 2002 and March 2008 with metastatic CRC who had been treated with capecitabine monotherapy after the failure of FOLFOX and FOLFIRI. Overall, one partial response was observed (overall response rate, 5%) and stable disease was observed in 11 patients (55.0%). The disease control rate was 60.0%. The median progression-free survival (PFS) was 2.3 months (95% CI 1.9-2.7) and the median overall survival (OS) was 5.3 months (95% CI 4.6-6.0). Patients without ascites had longer PFS than those with ascites (P=0.02). Patients with more than three metastatic sites had poorer OS than those with less than two (P=0.01). Grade 3 or 4 non-hematological toxicities included hand-foot syndrome in one patient. There were no grade 3 or 4 hematological toxicities or treatment-related deaths. The capecitabine monotherapy had a moderate disease control rate and a tolerable toxicity profile as third-line or fourth-line treatment for metastatic CRC patients who were refractory to standard chemotherapy with no further treatment options.

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