, Volume 62, Issue 5, pp 763-768
Date: 03 Jan 2008

A phase II study of capecitabine plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer

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Abstract

Purpose

This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.

Patients and methods

We enrolled 63 patients who received capecitabine 830 mg/m2 orally twice daily on days 1–21 plus gemcitabine 1000 mg/m2 as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles.

Results

A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13–34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5–5.7) and 7.5 months (95% CI 5.0–10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand–foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent.

Conclusion

The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.