Moehler M, Xiao H, Blum SI, Elimova E, Cella D, Shitara K, Ajani JA, Janjigian YY, Garrido M, Shen L, Yamaguchi K, Liu T, Schenker M, Kowalyszyn R, Bragagnoli AC, Bruges R, Montesarchio V, Pazo-Cid R, Hunter S, Davenport E, Wang J, Kondo K, Li M, Wyrwicz L. Health-Related quality of life with nivolumab plus chemotherapy versus chemotherapy in patients with advanced gastric/gastroesophageal junction cancer or esophageal adenocarcinoma from CheckMate 649. J Clin Oncol. 2023 Dec 10;41(35):5388-99. doi: 10.1200/JCO.23.00170

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.

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