Nivolumab Plus Chemotherapy Decreases Risk of Deterioration in Health-Related Quality of Life for Patients With Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma

3-Year Health-Related Quality of Life Results From CheckMate 649

According to the 36-month follow-up results from the CheckMate 649 trial, patients with gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma who were treated with nivolumab plus chemotherapy generally maintained health-related quality of life compared to chemotherapy alone.

These data were presented by Markus Moehler, MD, Johannes Gutenberg-University of Mainz, Germany, at the 2023 World Congress on Gastrointestinal Cancers in Barcelona, Spain.

CheckMate 649 was an open-label phase 3 study that randomized 1581 patients with gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma to receive either chemotherapy alone or nivolumab plus chemotherapy. As previously reported, primary results showed that there was a statistically significant improvement in overall survival and progression-free survival for those patients who received nivolumab plus chemotherapy and who had tumors with a PD-L1 combined positive score (CPS) ≥ 5. The 24-month follow-up results showed that those patients with PD-L1 CPS ≥ 5 generally maintained the health-related quality of life and had lower a lower risk of deterioration when treated with nivolumab plus chemotherapy plus chemotherapy alone.

Functional Assessment of Cancer Therapy—Gastric Cancer (FACT-Ga) and EQ-5D-3L tools were performed at baseline and every 6 weeks during the treatment to measure health-related quality of life. Longitudinal change from baseline were analyzed and time to first symptom deterioration, time until definitive deteriorataion, and time to improvement were estimated with deterioration and improvement based on prespecified meaningful threshold changes.

The 822 patients included in this 36-month follow-up analysis all have CPS ≥ 5, and both baseline and post-baseline patient-reported outcomes (combination arm, n = 422; chemotherapy alone arm; n = 400). At most time points, least-squares mean differences for EG-5D, FACT-Ga total, Gastric Cancer Subscale, and Physical Well-Being scores favored nivolumab plus chemotherapy. While FACT-G GP5 “I am bothered by side effects of treatment” responses initially increased for both arms post-baseline, they decreased over time in the combination arm and remained relatively stable in the chemotherapy alone group. Time to improvement slightly favored nivolumab plus chemotherapy for the majority of HR > 1 but there were no significant differences between the two arms. Time to symptom deterioration favored the combination arm with all HR < 1 with a significantly decreased risk of deterioration.

At most points, the longitudinal change from baseline in all quality of life measurement tools used favored nivolumab plus chemotherapy. As Dr Moehler et al concluded the combination treatment “decreased deterioration risk compared with [chemotherapy] alone with the improvement of [overall survival] and [progression-free survival], suggesting favorable benefits in [first-line] therapy for patients with CPS ≥ 5.”

Source:

Moehler M, Wyrwicz L, Chen C, et al. Health-related quality of life (HRQOL) in patients with advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma cancer (GC/GEJC/EAC): 36-month results of CheckMate 649 nivolumab plus chemotherapy N+C) versus chemo (C). Presented at the 2023 World Congress on Gastrointestinal Cancers; June 28-July 1, 2023; Barcelona, Spain. Abstract O-10