Compared with chemotherapy alone, nivolumab added to chemotherapy maintained health-related quality of life (HRQOL) with a decreased risk of symptom deterioration in patients with previously untreated advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC)

These findings were presented by Elena Elimova, MD, University of Texas MD Anderson Cancer Center, Houston, lead author of this study, at the 2021 ASCO Quality Care Symposium.

CheckMate 649 is a randomized, open label phase 3 study examining first-line treatment of patients with advanced GC/GEJC or EAC.

 “Primary analysis results showed statistically significant improvement in overall survival (OS) for nivolumab plus chemotherapy vs chemo in all randomized patients,” wrote Dr Elimova and colleagues. This analysis looked at HRQOL in these patients.

EQ-5D-3L (EQ-5D) and Functional Assessment of Cancer Therapy–Gastric Cancer (FACT-Ga) were used to evaluate HRQOL. These assessments were conducted at baseline, every 6 weeks during treatment, and during follow-up.

Mixed models were used to examine changes from BL EQ-5D Visual Analog Scale, Utility Index and FACT-Ga scores. Kaplan-Meier estimators and stratified Cox models were used to calculate time to first symptom deterioration, time until definitive deterioration, and time to improvement.

Of the 1581 patients included in this study, 789 were randomly assigned to the nivolumab plus chemotherapy group, and the remaining 792 were randomly assigned to the chemotherapy alone group.

Patients with baseline and post-baseline patient-reported outcomes (1359 patients; 693 of whom receiving nivolumab plus chemotherapy and 666 receiving chemo), held similar baseline scores between both treatment groups for FACT-Ga.

Differences from baseline favored nivolumab plus chemotherapy at most visits for EQ-5D, FACT-Ga total, and Gastric Cancer Subscale. Time to improvement mostly favored nivolumab plus chemotherapy, however a significant difference was not observed between arms.

Time to first symptom (with the exception of Emotional Well-Being) deterioration was longer in those receiving nivolumab plus chemotherapy. The only significant difference between arms was observed in the GaCS and FACT-Ga total. Significant delays in deterioration in nearly all scores (all but social well-being) were observed in time until definitive deterioration.

“Compared with chemo alone, the addition of NIVO [nivolumab] to chemo maintained HRQoL with a decreased risk of symptom deterioration in patients with previously untreated advanced or metastatic GC/GEJC/EAC,” wrote Dr Elimova and colleagues.

“Together with improved OS, these data support NIVO+chemo as a new 1L [first-line] standard treatment for GC/GEJC/EAC,” they concluded.

Elimova E, Wyrwicz L, 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): Results of nivolumab plus chemotherapy (NIVO+chemo) versus chemo from CheckMate 649. Presented at: the 2021 ASCO Quality Care Symposium; September 25-26, 2021; Boston, MA, and virtual; Abstract 167.