Camrelizumab combined with chemotherapy followed by camrelizumab plus apatinib as first-line therapy for advanced gastric or gastroesophageal junction adenocarcinoma
Mené sur 48 patients atteints d'un cancer gastrique ou d'un adénocarcinome de la jonction oesogastrique de stade avancé, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse globale, et la toxicité d'un traitement de première ligne comportant le camrélizumab en combinaison avec une chimiothérapie de type CAPOX puis le camrélizumab en combinaison avec l'apatinib
Purpose: Capecitabine plus oxaliplatin (CAPOX) is one of standard first-line treatments for unresectable, advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Camrelizumab shows promising anti-tumor activity in advanced or metastatic G/GEJ adenocarcinoma in a phase I study. We reported the outcomes of cohort 1 in a multicenter, open-label, phase II trial, which assessed camrelizumab in combination with CAPOX followed by camrelizumab plus apatinib as first-line combination regimen for advanced or metastatic G/GEJ adenocarcinoma. Patients and Methods: Systemic treatment naïve patients with human epidermal growth factor receptor 2-negative advanced or metastatic G/GEJ adenocarcinoma received initial camrelizumab plus CAPOX for 4-6 cycles, and patients without progressive disease were administrated subsequent camrelizumab plus apatinib. Primary endpoint was objective response rate (ORR). Results: All 48 enrolled patients comprised the efficacy and safety analysis population. The ORR was 58.3% (95% CI, 43.2-72.4) with this combination regimen. Median duration of response was 5.7 months (95% CI, 4.4-8.3). Median overall survival was 14.9 months (95% CI, 13.0-18.6), and median progression-free survival was 6.8 months (95% CI, 5.6-9.5), respectively. The most common Grade {greater than or equal to}3 treatment-related adverse events (>10%) were decreased platelet count (20.8%), decreased neutrophil count (18.8%) and hypertension (14.6%). Treatment-related death occurred in one (2.1%) patient due to hepatic function abnormal and interstitial lung disease. Conclusions: Camrelizumab combined with CAPOX followed by camrelizumab plus apatinib demonstrated encouraging antitumor activity and manageable toxicity as first-line therapy for patients with advanced or metastatic G/GEJ adenocarcinoma. Trial registration: ClinicalTrials.gov, NCT03472365.