OBJECTIVES: Lung cancer is the most common cancer globally, accounting for an estimated 1.8 million lives in 2018. Nivolumab has emerged as a promising agent for the management of lung cancer. 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 lung cancers

METHODS: A systematic literature review was performed across major biomedical to identify all randomised controlled trials reporting PRO data with nivolumab treatment across all lung cancers.

RESULTS: The review included seven relevant studies from 13 publications published between 2015 to 2023. Five studies were conducted globally, two in US and Canada. Five studies assessed nivolumab as monotherapy and three as combination therapy. Two studies assessed nivolumab in first line (LOT1), while five were in the second or further line (LOT≥2) setting. Time points of assessment were 102 weeks for LOT1 and ranged from 42-84 weeks for LOT≥2. LCSS ASBI (n=6), LCSS 3-IGI (n=5), EQ5D VAS (n=6), and EQ-5D UI (n=5) were the commonly assessed Qol instruments. Clinically meaningful improvement (CMI) in EQ-5D VAS (cut-off 7) and EQ-5D UI (cut-off 0.08) was observed with nivolumab (LOT≥2: 2 studies each) and nivolumab + ipilimumab (LOT1: n=1 each). Three studies showed CMI (cut-off 10) in LCSS ASBI with nivolumab ± ipilimumab as compared to chemotherapy/docetaxel. Similar findings were observed with the LCSS 3-IGI scale (cut-off 30). Nivolumab showed significant improvement in the above Qol scores as compared to chemotherapy at few time points across the studies.

CONCLUSIONS: Nivolumab showed improved Qol as compared to docetaxel and chemotherapy alone. Adding ipilimumab to a combination of nivolumab ± chemotherapy did not provide an additional benefit in terms of PROs.