PMID- 37029843 OWN - NLM STAT- MEDLINE DCOM- 20230623 LR - 20230830 IS - 1436-3305 (Electronic) IS - 1436-3291 (Print) IS - 1436-3291 (Linking) VI - 26 IP - 4 DP - 2023 Jul TI - Perioperative TAS-118 plus oxaliplatin in patients with locally advanced gastric cancer: APOLLO-11 study. PG - 614-625 LID - 10.1007/s10120-023-01388-z [doi] AB - BACKGROUND: We investigated the feasibility of perioperative chemotherapy with S-1 and leucovorin (TAS-118) plus oxaliplatin in patients with locally advanced gastric cancer. METHODS: Patients with clinical T3-4N1-3M0 gastric cancer received four courses of TAS-118 (40-60 mg/body, orally, twice daily for seven days) plus oxaliplatin (85 mg/m(2), intravenously, day one) every two weeks preoperatively followed by gastrectomy with D2 lymphadenectomy, followed by postoperative chemotherapy with either 12 courses of TAS-118 monotherapy (Step 1) or eight courses of TAS-118 plus oxaliplatin (Step 2). The primary endpoints were completion rates of preoperative chemotherapy with TAS-118 plus oxaliplatin and postoperative chemotherapy with TAS-118 monotherapy (Step 1) or TAS-118 plus oxaliplatin (Step 2). RESULTS: Among 45 patients enrolled, the preoperative chemotherapy completion rate was 88.9% (90% CI 78.0-95.5). Major grade >/= 3 adverse events (AEs) were diarrhoea (17.8%) and neutropenia (8.9%). The R0 resection rate was 95.6% (90% CI 86.7-99.2). Complete pathological response was achieved in 6 patients (13.3%). Dose-limiting toxicity was not observed in 31 patients receiving postoperative chemotherapy (Step 1, n = 11; Step 2, n = 20), and completion rates were 90.9% (95% CI 63.6-99.5) for Step 1 and 80.0% (95% CI 59.9-92.9) for Step 2. No more than 10% of grade >/= 3 AEs were observed in patients receiving Step 1. Hypokalaemia and neutropenia occurred in 3 and 2 patients, respectively, receiving Step 2. The 3-year recurrence-free and overall survival rates were 66.7% (95% CI 50.9-78.4) and 84.4% (95% CI 70.1-92.3), respectively. CONCLUSIONS: Perioperative chemotherapy with TAS-118 plus oxaliplatin with D2 gastrectomy is feasible. CI - (c) 2023. The Author(s). FAU - Takahari, Daisuke AU - Takahari D AUID- ORCID: 0000-0002-2492-6014 AD - Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. daisuke.takahari@jfcr.or.jp. FAU - Katai, Hitoshi AU - Katai H AD - Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan. FAU - Takashima, Atsuo AU - Takashima A AD - Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Izawa, Naoki AU - Izawa N AD - Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. FAU - Ishizuka, Naoki AU - Ishizuka N AD - Department of Clinical Planning and Strategy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. FAU - Ohashi, Manabu AU - Ohashi M AD - Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. FAU - Mikami, Shinya AU - Mikami S AD - Department of Gastrointestinal and General Surgery, St. Marianna University School of Medicine, Kawasaki, Japan. FAU - Wakatsuki, Takeru AU - Wakatsuki T AD - Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Nakayama, Izuma AU - Nakayama I AD - Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Chin, Keisho AU - Chin K AD - Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Ida, Satoshi AU - Ida S AD - Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. FAU - Kumagai, Koshi AU - Kumagai K AD - Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. FAU - Nunobe, Souya AU - Nunobe S AD - Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. FAU - Iwasa, Satoru AU - Iwasa S AD - Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Shoji, Hirokazu AU - Shoji H AD - Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Wada, Takeyuki AU - Wada T AD - Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan. FAU - Doi, Ayako AU - Doi A AD - Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. FAU - Yoshikawa, Takaki AU - Yoshikawa T AD - Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan. FAU - Sano, Takeshi AU - Sano T AD - Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. FAU - Boku, Narikazu AU - Boku N AD - Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Yamaguchi, Kensei AU - Yamaguchi K AD - Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. LA - eng PT - Journal Article DEP - 20230408 PL - Japan TA - Gastric Cancer JT - Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association JID - 100886238 RN - 04ZR38536J (Oxaliplatin) SB - IM MH - Humans MH - Oxaliplatin MH - *Stomach Neoplasms/drug therapy/surgery/pathology MH - Antineoplastic Combined Chemotherapy Protocols MH - Gastrectomy MH - *Neutropenia/drug therapy/etiology/surgery PMC - PMC10285008 OTO - NOTNLM OT - Gastric cancer OT - Gastroesophageal junction cancer OT - Oxaliplatin OT - Perioperative chemotherapy OT - TAS-118 COIS- D. Takahari reports funding and honoraria from Taiho Pharmaceutical, and provision of study materials from Taiho Pharmaceutical and Yakult Honsha. A. Takashima reports honoraria from Taiho Pharmaceutical. N. Izawa reports funding, research grant and honoraria from Taiho Pharmaceutical. K. Chin reports honoraria from Taiho Pharmaceutical. S. Iwasa reports research grant and honoraria from Taiho Pharmaceutical. H. Shoji reports an advisory role at Ono Pharmaceutical, and other financial interests at Astellas, Ono Pharmaceutical, Daiichi Sankyo, MSD, and Amgen. T. Yoshikawa reports honoraria from Taiho Pharmaceutical and Chugai. T. Sano reports honoraria from Taiho Pharmaceutical N. Boku reports funding from Taiho Pharmaceutical and Yakult, and research grants from Ono Pharmaceutical and Takeda, and honoraria from Taiho Pharmaceutical, Ono Pharmaceutical, Daiichi-Sankyo, and BMS. K. Yamaguchi reports funding from Ono Pharmaceutical, and honoraria from Ono Pharmaceutical and BMS. All other authors declare no competing interests. EDAT- 2023/04/09 06:00 MHDA- 2023/06/23 06:42 PMCR- 2023/04/08 CRDT- 2023/04/08 11:16 PHST- 2022/12/17 00:00 [received] PHST- 2023/03/27 00:00 [accepted] PHST- 2023/06/23 06:42 [medline] PHST- 2023/04/09 06:00 [pubmed] PHST- 2023/04/08 11:16 [entrez] PHST- 2023/04/08 00:00 [pmc-release] AID - 10.1007/s10120-023-01388-z [pii] AID - 1388 [pii] AID - 10.1007/s10120-023-01388-z [doi] PST - ppublish SO - Gastric Cancer. 2023 Jul;26(4):614-625. doi: 10.1007/s10120-023-01388-z. Epub 2023 Apr 8.