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Cancer Chemother Pharmacol. 2008 Oct;62(5):763-8. doi: 10.1007/s00280-007-0661-y. Epub 2008 Jan 3.

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

Author information

  • 1Division of Hematooncology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Dongsan-Dong, Chung-Gu, Daegu 200-712, South Korea. shs7436@dsmc.or.kr

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/m(2) orally twice daily on days 1-21 plus gemcitabine 1000 mg/m(2) 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.

PMID:
18172648
[PubMed - indexed for MEDLINE]
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