Alexandria, VA. Patients in the phase 3 CheckMate-649 trial (NCT02872116) who received nivolumab (Opdivo) plus chemotherapy reported stable or better on-treatment health-related quality of life (HRQOL) compared with chemotherapy alone. CheckMate-649 included patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma, and findings were published in the Journal of Clinical Oncology.
Key Findings
Overall, patients who received nivolumab plus chemotherapy had significant improvements in their Functional Assessment of Cancer Therapy – Gastric (FACT-Ga) total, Gastric Cancer subscale (GaCS), and EuroQoL five-dimensional instrument (EQ-5D) visual analog scale scores than patients who received chemotherapy alone. This was consistent in both the subset of patients with a tumor PD-L1 expression combined positive score (CPS) of 5 and greater, as well as in the entire patient-reported outcome (PRO) population analysis.
Further, in both the subset and entire population of participants, the time to definitive deterioration was longer, and the risk of symptom deterioration and definitive deterioration was reduced.
In both the CPS > 5 populations and the total population, the FACT-Ga total, GaCS, and EQ-5D VAS scores appeared to improve overtime from baseline in both treatment arms. However, for each of the three measures, the least-squared mean changes favored nivolumab plus chemotherapy.
CheckMate-649 randomly assigned 1,581 patients to received either nivolumab plus chemotherapy or chemotherapy alone. Approximately 60% of patient in either arm had a PD-L1 CPS score of 5 or greater. Other baseline characteristics were also considered balanced between the 2 treatment arms. Most patients were male (71%), White (67%), had an ECOG performance status of 1 (56%) and had received a gastric cancer diagnosis as their primary tumor location (71%).
The PRO analysis included 1,360 patients, 80% of whom completed all the PRO questionnaires throughout treatment.
Findings in Context
Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma have similar molecular profiles and can be considered as a single disease entity, according to study authors. Further, this group of cancers represents a leading cause of global-cancer related mortality. Chemotherapy has limited success in this setting and is associated with significant treatment-related toxicity; it is also associated with a median overall survival of less than 1 year.
Previous reports from the CheckMate 649 trial demonstrated that frontline nivolumab plus chemotherapy elicited a longer median progression-free survival in this patient population than chemotherapy alone. Consequently, nivolumab, in combination with chemotherapy, was approved in April 2021 for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
In addition, findings presented at the 2023 Gastrointestinal Cancers Symposium showed that patients who received dual therapy achieved a median overall survival of 13.7 months (95% CI, 12.4-14.5) whereas those who received chemotherapy alone achieved a median overall survival of 11.6 months (95% CI, 10.9-12.5), yielding a hazard ratio of 0.79 (95% CI, 0.71-0.88).
According to the study authors, these findings are important in talking to patients about their treatment options, as it helps them understand how their quality of life may be impacted by treatment.
“Considering the limited life expectancy of patients with advanced disease, it is important to assess the HRQOL to weigh the benefits and risks of treatment from the patient’s perspective,” they noted in the study.
Further, as JCO Associate Editor Andrew H. Ko, MD, FASCO, noted, these findings may help patients who are eligible for immunotherapy feel better about the treatment modality, as they may provide “reassurance that the benefits of adding nivolumab to chemotherapy extend not only to improved survival, but also to preservation of their quality of life and prolonged symptom control.”
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