Docetaxel-oxaliplatin-capecitabine/5 fluorouracil (DOC/F) followed by docetaxel versus Oxaliplatin-Capecitabine/5 fluorouracil (CAPOX/mFOLFOX-7) in HER2 negative advanced gastric cancers

We evaluated addition of docetaxel (D) to a combination comprising 5-fluorouracil/leucovorin(5-FU/LV) or capecitabine (C) plus oxaliplatin (O) (DOF/DOX) improved overall survival (OS) compared to six months of FOLFOX/CAPOX alone in advanced HER2-negative gastro-esophageal junction and gastric adenocarcinomas (GEJ/GC). This study was an investigator-initiated, open-label, multi-institutional, randomized phase III trial in adult patients with HER2-negative advanced GEJ/GCs. The primary end point of the study was a comparison of median OS by Kaplan-Meier method. Next-generation sequencing was performed on tissue. Of the 324 patients randomized between July 2020 and November 2022, 305 patients were evaluable for analysis (FOLFOX/CAPOX: 156; DOF/DOX: 149). With a median follow-up time of 19.2 months (95% CI: 16.5-21.9) for the entire cohort, the median OS was 10.1 months (95%: 9.2-10.9) for FOLFOX/CAPOX and 8.9 months (95% CI: 7.3-10.5) for DOF/DOX and this difference was not statistically significant [p = .70]. An increased proportion of grade 3/4 neutropenia (21% vs 3%; p