%0 Journal Article %A YUSAKU TANAKA %A CHIKARA KUNISAKI %A YUSUKE IZUMISAWA %A HIROCHIKA MAKINO %A JUN KIMURA %A SHO SATO %A HIROSHI MIYAMOTO %A TAKASHI KOSAKA %A HIDETAKA A. ONO %A MASAZUMI TAKAHASHI %A KEI SATO %A HIROTOSHI AKIYAMA %A ITARU ENDO %T A Phase I/II Study of NAC with Docetaxel, Cisplatin, and S-1 for Stage III Gastric Cancer %D 2018 %R 10.21873/anticanres.12951 %J Anticancer Research %P 6015-6021 %V 38 %N 10 %X 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 mg/day to 120 mg/day depending on the body surface area and docetaxel was administered at 20 mg/m2, whereas cisplatin was initially administered at 25 mg/m2 and was escalated by 5 mg/m2 up to 50 mg/m2. 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/m2/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 (R0) 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. %U https://ar.iiarjournals.org/content/anticanres/38/10/6015.full.pdf