Annals of Oncology 13:1893-1898, 2002
© 2002 European Society for Medical Oncology
Original Paper |
Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer
1 Section of Hematology–Oncology, Department of Medicine and 2 Department of General Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
Received 25 February 2002; revised 22 April 2002; accepted 13 May 2002
Background:
A phase II study was conducted to assess the efficacy and tolerability of combination therapy with capecitabine and cisplatin in patients with advanced gastric cancer.
Patients and methods:
Patients with previously untreated metastatic or unresectable measurable gastric adenocarcinoma received oral capecitabine 1250 mg/m2 twice daily, days 1–14, and i.v. cisplatin 60 mg/m2 on day 1. This cycle was repeated every 3 weeks.
Results:
Forty-two patients were enrolled in this study. Of these, 38 patients were assessable for efficacy and 40 were assessable for toxicity. One patient achieved a complete response and 22 patients had partial responses, giving an overall response rate of 54.8% in the intention-to-treat population (95% confidence interval 39.8% to 69.8%). The median time to progression was 6.3 months and the median overall survival was 10.1 months. The principal adverse events were neutropenia and hand-foot syndrome. Grade 3/4 adverse events were neutropenia (32.5% of patients), thrombocytopenia (10%), stomatitis (2.5%) and diarrhea (5%). Grade 2 and 3 hand–foot syndrome occurred in 20% and 7.5% of patients, respectively. There were no treatment-related deaths.
Conclusions:
The combination of capecitabine and cisplatin is active and well tolerated in patients with advanced gastric cancer.
Key words: capecitabine, chemotherapy, cisplatin, stomach cancer
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