Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2–Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC—A Randomized Phase III Trial

摘要: PurposeTo evaluate the efficacy of adding lapatinib to capecitabine and oxaliplatin (CapeOx) in patients with previously untreated human epidermal growth factor receptor 2 (HER2) –amplified advanced gastroesophageal adenocarcinoma.Patients MethodsPatients HER2-positive adenocarcinoma were randomly assigned at a one-to-one ratio CapeOx plus 1,250 mg or placebo daily. Primary end point was overall survival (OS) centrally confirmed HER2 amplification primary population.ResultsA total 545 assigned, 487 comprised population. Median OS arms 12.2 (95% CI, 10.6 14.2) 10.5 months 9.0 11.3), respectively, which not significantly different (hazard ratio, 0.91; 95% 0.73 1.12). progression-free 6.0 5.6 7.0) 5.4 4.4 5.7), respectiv...