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. Methods: 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). Results: 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. Conclusions: 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.