Aim: 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). Methods: 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. Results: 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 2.3months (95% CI 1.9-2.7) and the median overall survival (OS) was 5.3months (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. Conclusion: 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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