1. ¹Division of Oncology, Department of Medicine, Asan Medical Center, 388-1 Pungnap-dong, Songpa-gu, Seoul 138-736, South Korea
2. ²Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea

Correspondence: Dr Y-K Kang, E-mail: ykkang@amc.seoul.kr

Received 22 July 2004; Revised 22 November 2004; Accepted 23 November 2004; Published online 18 January 2005.

Abstract

To evaluate the efficacy and safety of capecitabine and cisplatin in patients with recurrent gastric cancer after fluoropyrimidine-based adjuvant therapy. Patients with histologically confirmed and measurable advanced gastric cancer that had relapsed after fluoropyrimidine-based adjuvant chemotherapy received oral capecitabine (1250 mg m^-2 twice daily, days 1–14) and intravenous cisplatin (60 mg m^-2 over 1 h, day 1) every 3 weeks. In total, 32 patients were enrolled, of whom 30 were evaluable for efficacy and 32 for safety. A median of 5 cycles (range 1–10) was administered. One patient achieved a complete response and eight had partial responses, giving an overall response rate of 28% (95% CI, 13–44%). The median time to progression and median overall survival were 5.8 months (95% CI, 4.1–7.5 months) and 11.2 months (95% CI, 5.5–16.9 months), respectively. Grade 3 neutropenia and thrombocytopenia were observed in 38 and 6% of patients, respectively. Grade 2/3 nonhaematological toxicities included diarrhoea (19%), stomatitis (19%) and hand-foot syndrome (31%). No grade 4 toxicity, neutropenic fever or treatment-related deaths occurred. Capecitabine in combination with cisplatin was effective and well tolerated as first-line treatment in patients with recurrent gastric cancer after fluoropyrimidine-based adjuvant chemotherapy.