S-1 combined with oxaliplatin or cisplatin in neoadjuvant chemotherapy for stage IIb/III gastric adenocarcinoma - efficacy and safety results of a randomized clinical trial

Abstract

Background: We evaluated the efficacy and safety of S-1 plus oxaliplatin (SOX) or cis-platin (CS) in neo-adjuvant chemotherapy for resectable local advanced gastric cancer. Method(s): In this randomized prospective study, gastric adenocarcinoma was confirmed by pathologist. Before radical gastrectomy with D2 lymphadenectomy were performed, patients were randomly assigned to receive three-cycles neo-adjuvant chemotherapy with SOX or CS. The primary endpoint was overall response rates (ORR), secondary endpoints were safety, perioperative complications, 3-year disease free survival (DFS) and median overall survival (mOS). Result(s): Overall 205 patients were enrolled from December 2014 to September 2016. Efficacy and safety were evaluated for all enrolled patients. ORR were not statistically different between SOX (54.4%) andCS (52.9). The most common > grade 3 adverse enents (SOXvsCS) were leukopenia (2.9% vs 10.8%), neutropenia (15.5% vs39.2%), anemia (5.8% vs 10.8%) and febrile neutropenia (8.7% vs 3.9%). 189 patients received radical gastrectomy with D2 lymphadenectomy; erioperative complications were found in 16.7% (SOX) and 21.5% (CS) patients, respectively. Conclusion(s): SOX is as effective as CS for local advanced gastric cancer with more favorable safety profile during neo-adjuvant chemotherapy. Follow-up is ongoing, and survival data will be reported in the future.