An open-label phase II study of intermittent oral capecitabine (X) as first-line treatment for patients (pts) with metastatic colorectal cancer (MCRC)

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3730 Background: X is an orally administered, fluoropyrimidine carbamate that is converted to 5-FU in tumors by the enzyme thymidine phosphorylase (TP). The localization of TP within tumors results in higher concentrations of 5-FU within tumors compared with plasma and normal tissues. X has been shown to be highly active and well tolerated in both MCRC and as adjuvant therapy in pts with early-stage colon cancer. Methods: We studied the efficacy and safety of capecitabine as first-line treatment in an open label, phase II study in MCRC. Pts received X at a dose of 1250mg/m2 twice daily on days 114, every 3 weeks for 16 cycles. Results: Baseline characteristics of the 64 pts enrolled between May 2003 and Oct 2003 at 9 centers: 33 men and 31 women; median age 63 years (range 18–81). Main sites of metastases were: liver, lung, and lymph nodes. The overall best response rate was 20%, including complete responses in 3% of pts. The median time to response was 1.4 months (95% CI, 1.3–2.0 months). The median time to disease progression was 5.8 months (95% CI, 3.0–7.6 months). At the time of the analysis (Oct 2004), the median overall survival was 10.5 months (95% CI, 6.8–12.2 months). The most common treatment-related adverse events (all grades combined) were: hand-foot syndrome, nausea/vomiting, fatigue, diarrhea, fever, anorexia, abdominal pain, and dizziness. The most common treatment-related grade 3/4 adverse events (NCIC-CTC) were fatigue 8%, diarrhea 6%, hand-foot syndrome 5%, nausea 5%, vomiting 5%, and fever 5%. Conclusion: Oral X is both effective and well tolerated as first-line treatment for Chinese pts with MCRC. No significant financial relationships to disclose.