Phase II study of capecitabine and cisplatin as first-line combination therapy in patients with gastric cancer recurrent after fluoropyrimidine-based adjuvant chemotherapy

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 mgm(-2) twice daily, days 1 - 14) and intravenous cisplatin ( 60 mgm(-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.