Purpose: To evaluate the therapeutic effectiveness and safety of treatment with capecitabine and mitomycin-C (MMC) in patients with metastatic colorectal cancer previously treated with at least one chemotherapy regimen for recurrent or metastatic disease.

Patients And Methods: A total of 36 patients (male/female 21/15, median age 62.5 years) with metastatic colorectal cancer were treated with capecitabine and MMC as their second, third or fourth line chemotherapy regimen. Chemotherapy consisted of intravenous MMC 6 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-15 followed by 7-day rest. Treatment courses were repeated every 3 weeks unless there was evidence of progressive disease or unacceptable toxicity.

Results: All 36 patients were evaluable for toxicity and response. A total of 175 cycles were administered (median 4.86, range 3-6). Two (5.6%) patients achieved complete response, 3 (8.3%) partial response, 14 (38.9%) had stable disease and 16 (44.4%) patients progressed. Median time to tumor progression (TTP) was 4.5 months and median overall survival (OS) 13 months. No toxic deaths occurred. Toxicity was mild and easily manageable.

Conclusion: This retrospective study demonstrated that the combination of capecitabine and MMC is an effective and well-tolerated regimen for patients previously treated for metastatic or recurrent colorectal cancer.

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