AIO INTEGA Provides Further Support for Immunotherapy in Patients With Advanced ERBB2-Positive Gastroesophageal Adenocarcinoma
Mené en Allemagne sur 88 patients atteints d'un adénocarcinome oesogastrique ERBB2+ (durée médiane de suivi : 14,3 mois), cet essai de phase II analyse l'efficacité, du point de vue de la survie globale, et la toxicité de l'ipilimumab par rapport à une chimiothérapie de type mFOLFOX6, dispensés en combinaison avec le trastuzumab et le nivolumab en traitement de première ligne
The AIO INTEGA randomized clinical trial was a phase 2 multicenter study that evaluated the efficacy of first-line nivolumab and trastuzumab in combination with either ipilimumab (hereinafter the ipilimumab group) or trastuzumab and nivolumab in combination with mFOLFOX6 (hereinafter the FOLFOX group) in patients with advanced esophagogastric adenocarcinoma (EGA) positive for ERBB2 (formerly HER2). The primary end point of the study was overall survival (OS). The efficacy of the 2 regimens was analyzed independently of each other, each in relation to the current standards based on the ToGA trial. The majority of the enrolled patients were male (74%), with 66 of 88 randomized patients having gastroesophageal junction adenocarcinoma and the rest having gastric adenocarcinoma. In the FOLFOX group, OS of 21.8 months and OS rate of 70% at 12 months were significantly improved compared with the historical control from the ToGA trial. In the ipilimumab group, OS of 16.4 months and OS rate of 57% at 12 months were similar to the ToGA regimen. As expected, there were more immune-mediated adverse events with the combination of nivolumab and ipilimumab, but both regimens had acceptable toxic effects.
JAMA Oncology , commentaire, 2021