FOLFOX alone or combined with rilotumumab or panitumumab as first-line treatment for patients with advanced gastroesophageal adenocarcinoma (PRODIGE 17-ACCORD 20-MEGA): a randomised, open-label, three-arm phase II trial.

摘要: Abstract Background Epidermal growth factor receptor (EGFR) and hepatocyte (HGF)/mesenchymal–epithelial transition (MET) pathways, which promote tumour proliferation, are often deregulated in advanced gastroesophageal adenocarcinomas. We assessed whether adding panitumumab (an EGFR inhibitor) or rilotumumab (a HGF to first-line fluoropyrimidine-based platinum-based chemotherapy (modified oxaliplatin, leucovorin fluorouracil [mFOLFOX6]) benefits patients with adenocarcinoma. Patients methods This phase II, open-label, randomised, three-arm study enrolled ≥18 years, adenocarcinoma, Eastern Cooperative Oncology Group performance status 0–1 no known HER2 overexpression. were randomly assigned (1:1:1) mFOLFOX6 (oxaliplatin 85 mg/m2, 400 mg/m2, 5-fluorouracil 400 mg/m2 bolus then 2400 mg/m2 over 46 h) alone combined (6 mg/kg) (10 mg/kg) every 2 weeks until limiting toxicity, patient's refusal disease progression. The primary end-point was the 4-month progression-free survival (PFS) rate. Secondary end-points included overall (OS) tolerance. Results 162 29 French centres. median follow-up 23.6 months (interquartile range = 16.4–29.0). PFS rate 71% (95% confidence interval [CI] 57–82) alone, 57% CI 42–71) 61% 47–74) rilotumumab. Median OS 13.1 8.7–16.9) 8.3 6.2–13.2) 11.5 7.9–17.1) Adverse events grade ≥III occurred less frequently (62%) than (83%) (89%). Conclusions found benefit treat adenocarcinoma patients. Trial registration European Clinical Trials Database, number 2009-012797-12.