A Phase I/II Study of NAC with Docetaxel, Cisplatin, and S-1 for Stage III Gastric Cancer

Background/Aim: The aim of this phase I/II study was to determine the safety, and efficacy of combination of neoadjuvant chemotherapy (NAC) with biweekly docetaxel, cisplatin, and S-1 (DCS) in stage III gastric cancer patients. Patients and Methods: In the phase I study, S1 was administered at doses of 80 mglday to 120 mglday depending on the body surface area and docetaxel was administered at 20 mg/m(2), whereas cisplatin was initially administered at 25 mg/m(2) and was escalated by 5 mg/m(2) up to 50 mg/m(2). In the phase II study, safety and therapeutic efficacy of DCS were evaluated using the recommended dose of cisplatin. Results: In phase I, 21 patients were enrolled. In level II, perforation of gastric cancer occurred in one case although no dose limiting toxicities (DLTs) were noted in level III-VI. Recommended dose for cisplatin was 50 mg/m(2)/day. In phase II, among 47 patients, 14 experienced grade 3/4 adverse events. Clinically, response rate was 66.7% and disease control rate was 97.9%. The curative (RO) resection rate was 95.7%. Pathological response rate was 53.3%. Three-year overall survival and relapse free survival rates were 78.5% and 65.3%, respectively. Conclusion: Biweekly DCS as NAC was efficient, safe, and acceptable; however, long-term survival should be evaluated to confirm the efficacy of biweekly DCS for stage III gastric cancer patients.