Patients with advanced gastric, esophageal, or gastroesophageal junction cancer (GEJC) experience a decrease in health status and overall health-related quality of life (HRQOL) due to an increase in cancer-related symptoms and from the side effects of treatment.1 At the American Society of Clinical Oncology Quality Care Symposium 2021, researchers presented interim results on HRQOL in patients with advanced gastric cancer, esophageal adenocarcinoma, or GEJC receiving nivolumab plus chemotherapy versus chemotherapy alone. The data were obtained from the CheckMate-649 clinical trial, a randomized, phase 3 study of first-line treatment in this patient population.
In this study, all randomized patients and patients with tumors expressing PD-L1 combined positive score (CPS) ≥5 demonstrated a statistically significant improvement in progression-free survival and overall survival with treatment with nivolumab plus chemotherapy. HRQOL was evaluated at baseline, every 6 weeks during the treatment period, and at follow-up with the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) questionnaire and the EQ-5D-3L descriptive system. Time to first symptom deterioration, time until definitive deterioration (TuDD), and time to improvement were also reported in this study.
From a pool of 1581 patients treated during the clinical trial, 955 patients were found to have a CPS ≥5. Of the CPS ≥5 patients, 473 had been receiving nivolumab plus chemotherapy and 482 patients received chemotherapy alone. The baseline scores for FACT-Ga were similar for both treatment groups. Score differences from baseline generally were better for those patients receiving nivolumab plus chemotherapy when compared with patients receiving chemotherapy alone. The patients receiving nivolumab plus chemotherapy had a significant delay in deterioration and a decreased risk of deterioration and, although time to improvement generally favored this treatment group, it was not significantly different from the chemotherapy-alone group.
Analysis of TuDD demonstrated that the patients receiving nivolumab and chemotherapy had a significant deterioration delay. TuDD hazard ratio (HR) for physical well-being was 0.70; for social well-being, HR was 0.68. HR for emotional well-being was 0.65, and HR for functional well-being was 0.63. The FACT-Ga total HR was 0.62; for the GaCS subscale, HR was 0.57. For FACT-Ga, total HR was 0.56; for EQ-5D U I (UK set), HR was 0.65; and for EQ-5D visual analog scale, HR was 0.68.
First-line use of nivolumab plus chemotherapy in patients with advanced gastric cancer, esophageal adenocarcinoma, or GEJC led to better HRQOL compared with patients receiving chemotherapy alone.
Wyrwicz L, Elimova E, Blum S, et al. Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): interim results of nivolumab plus chemotherapy (N+C) versus (C) from CheckMate 649. J Clin Oncol. 2021;39(suppl_15):4066-4066.
- Van Cutsem E, Amonkar M, Fuchs CS, et al. Health-related quality of life in advanced gastric/gastroesophageal junction cancer with second-line pembrolizumab in KEYNOTE-061 [published correction appears in Gastric Cancer. 2021 Sep 18]. Gastric Cancer. 2021;24:1330-1340.