OBJECTIVES: Nivolumab has emerged as a promising agent for managing oesophageal cancers. However, measuring its impact on patient’s quality of life (Qol) requires a comprehensive assessment beyond traditional clinical endpoints. This study aims to evaluate the existing literature on patient-reported outcomes (PROs) with nivolumab across oesophageal cancers.

METHODS: An SLR was performed across major biomedical databases to identify the randomised controlled trials reporting PRO data with nivolumab across gastric and oesophageal cancers.

RESULTS: The review included four global studies from 14 publications published between 2019 to 2023. Two studies each assessed nivolumab combination and monotherapy. All the studies assessed advanced oesophageal or gastric carcinoma. EQ-5D VAS (n=2), EQ-5D UI (n=2), FACT-E (n=2), and FACT-Ga (n=1) were the PRO scales assessed across studies. Three studies assessed first-line of therapy (LOT1) and one assessed ≥2 lines (LOT≥2).

Nivolumab in LOT1 showed clinically meaningful improvement (CMI) (CFB cut-off 7) in EQ-5D VAS score (CFB: 9.78 (95% CI 6.88, 12.72) at several time points over 1 year, while LOT≥2 treatment showed no CMI (1.13 (-4.83, 7.62) at 42 weeks. Although showing improvement trends, both LOT1 and LOT≥2 nivolumab studies did not meet the CMI cut-off (0.08) for EQ-5D UI. Similar results were observed in LOT1 studies of nivolumab ± chemotherapy for FACT-E (cut-off 9.5) and FACT-Ga (cut-off 15.1) scales indicating maintained Qol over the treatment duration. Nivolumab ± chemotherapy was associated with significantly improved Qol compared to chemotherapy on the scales of EQ-5D VAS (HR 0.65, 95% CI 0.49, 0.86, p=0.0030), FACT-Ga (0.77 [0.63, 0.95]) and EQ-5D UI (0.73 [0.55, 0.97], p=0.032).

CONCLUSIONS: Nivolumab treatment showed trends of improvement in both esophageal/gastric-specific and general HRQoL. Patients treated with nivolumab did not experience a reduction in HRQoL, further supporting clinical data demonstrating treatment benefit and tolerability for nivolumab in gastric or oesophageal cancer patients.