Phase II study of preoperative chemotherapy with S-1 and cisplatin followed by gastrectomy for clinically resectable type 4 and large type 3 gastric cancers (JCOG0210).

摘要: Background and Objectives We conducted a phase II study to evaluate the safety efficacy of preoperative chemotherapy with S-1 + cisplatin followed by gastrectomy in patients linitis plastica (type 4) or large ulcero-invasive-type 3) gastric cancer. Methods Eligibility criteria included histologically proven adenocarcinoma stomach; clinically resectable cancer type 4 3. Patients received two 28-day courses S-1 (80–120 mg/body, p.o., days 1–21) cisplatin (CDDP; 60 mg/m2, i.v., day 8). Primary endpoints were completion protocol treatment incidence treatment-related death (TRD). Results Among 49 eligible median age 61 years, 36 completed comprising R0/1 resection (73.5% completion, 80% CI, 63.7–81.7%). One TRD was observed during first course chemotherapy. Median survival 3-year overall 17.3 months 24.5%, respectively. Conclusions Preoperative S-1 + CDDP is safe promising for 3 cancers. Based on results this study, we are now conducting III (JCOG0501) confirm superiority treatment. J. Surg. Oncol. 2013;107:741–745. © 2013 Wiley Periodicals, Inc.