A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601)

Purpose We conducted a phase II study to evaluate the efficacy and safety of a triplet regimen of docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer. Methods Docetaxel (40 mg/m 2 ) and cisplatin (70 or 60 mg/m 2 ) were given on day 1 of a 28-day cycle. S-1 (40 mg/m 2 ) was given twice daily on days 1–14. Treatment with this regimen was continued for a maximum of 6 cycles. Subsequently, patients with no disease progression received a combination of docetaxel and S-1. Results Fifty-nine patients were enrolled. The median number of administered cycles was 8 (range, 1–25). Because some patients had serious myelosuppression and renal dysfunction with 70 mg/m 2 of cisplatin, dose of cisplatin was reduced to 60 mg/m 2 after 19 patients had been treated. Common severe toxic effects of grade 3 or 4 were leukocytopenia (44%), neutropenia (72%), anemia (15%), and febrile neutropenia (14%). The overall response rate of this group was 81% (95% confidence interval (CI), 71–91%). The median overall survival and progression-free survival were 18.5 (95% CI, 15.6–21.5) and 8.7 (95% CI, 6.7–10.7) months, respectively. Conclusions Triplet of docetaxel, cisplatin, and S-1 is a well-tolerated and highly active regimen for advanced or recurrent gastric cancer. A 60 mg/m 2 of cisplatin is as effective as 70 mg/m 2 of cisplatin.