PURPOSE: In CheckMate 649, first-line nivolumab-plus-chemotherapy prolonged overall survival versus chemotherapy in patients with advanced/metastatic non-human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction cancer (GC/GEJC), or esophageal adenocarcinoma (EAC). We present exploratory patient-reported outcomes (PROs).
METHODS: In patients (N = 1581) concurrently randomized 1:1 to nivolumab-plus-chemotherapy or chemotherapy and in those with tumor programmed death-ligand 1 expression at combined positive score (CPS) ≥5, health-related quality of life (HRQoL) was assessed using the EQ-5D and Functional Assessment of Cancer Therapy-Gastric (FACT-Ga), which included the FACT-General (FACT-G) and Gastric Cancer subscale (GaCS). The FACT-G GP5 item assessed treatment-related symptom burden. Longitudinal changes in HRQoL were assessed using mixed models for repeated measures in the PRO analysis population (randomized patients with baseline and ≥1 post-baseline assessments). Time-to-symptom or definitive deterioration analyses were also conducted.
RESULTS: In the PRO analysis population (n = 1360), PRO questionnaire completion rates were mostly >80% during treatment. Patient-reported symptom burden was not increased with nivolumab-plus-chemotherapy versus chemotherapy. Mean improved changes from baseline were greater with nivolumab-plus-chemotherapy versus chemotherapy for FACT-Ga total, GaCS, and EQ-5D visual analog scale in patients with CPS ≥5; results were similar for the overall PRO analysis population. In CPS ≥5 and all randomized populations, nivolumab-plus-chemotherapy reduced the risk of symptom deterioration versus chemotherapy, based on FACT-Ga total score and GaCS; time-to-definitive deterioration was longer and the risk of definitive deterioration in HRQoL was reduced with nivolumab-plus-chemotherapy across EQ-5D and most FACT-Ga measures (hazard ratio [95% confidence interval] <1).
CONCLUSION: Compared to chemotherapy alone, first-line nivolumab-plus-chemotherapy showed stable or better on-treatment HRQoL in patients with advanced/metastatic non-HER2-positive GC/GEJC/EAC, and also showed decreased risk of definitive HRQoL deterioration.
