Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057.
BACKGROUND
Nivolumab, a programmed death-1 inhibitor, prolonged overall survival and had a favourable safety profile versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) in the phase III CheckMate 057 trial.


AIM
To evaluate health-related quality of life (HRQoL) using patient-reported outcomes.


METHODS
Disease-related symptoms and general health status were assessed using two validated patient-reported instruments, the Lung Cancer Symptom Scale (LCSS) and the European Quality of Life Five Dimensions (EQ-5D), respectively. The proportion of patients with disease-related symptom improvement at 12 weeks on the LCSS average symptom burden index (ASBI) was a secondary end-point. LCSS 3-item global index (3-IGI), EQ-5D utility index and EQ-5D visual analogue scale (VAS) scores were also determined. Mixed-effects model repeated measures (MMRM) and time to first deterioration analyses assessed longitudinal changes.


RESULTS
Mean baseline LCSS ASBI scores were similar in both arms. By week 12, rates of disease-related improvement (95% confidence interval) were similar between nivolumab (17.8% [13.6-22.7]) and docetaxel (19.7% [15.2-24.7]); however, numerical differences in LCSS ASBI mean change from baseline favoured nivolumab. Subsequently, LCSS ASBI scores improved with nivolumab and worsened with docetaxel, with statistically significant between-arm differences at weeks 12, 24, 30 and 42. HRQoL improvements with nivolumab versus docetaxel were also supported by the LCSS 3-IGI, EQ-5D VAS and MMRM analysis. Time to first HRQoL deterioration was longer with nivolumab than with docetaxel.


CONCLUSION
Nivolumab improved disease-related symptoms and overall health status versus docetaxel for second-line treatment of advanced non-squamous NSCLC.


CLINICAL TRIAL REGISTRATION
NCT01673867.
['Reck|Martin|M|', 'Brahmer|Julie|J|', 'Bennett|Bryan|B|', 'Taylor|Fiona|F|', 'Penrod|John R|JR|', 'DeRosa|Michael|M|', 'Dastani|Homa|H|', 'Spigel|David R|DR|', 'Gralla|Richard J|RJ|']
D000074322:Antineoplastic Agents, Immunological D002289:Carcinoma, Non-Small-Cell Lung D017281:Cost of Illness D000077143:Docetaxel D006304:Health Status D006801:Humans D008175:Lung Neoplasms D000077594:Nivolumab D000071066:Patient Reported Outcome Measures D011237:Predictive Value of Tests D011788:Quality of Life D013997:Time Factors D016896:Treatment Outcome
Quality of life Non-small cell lung Nivolumab Docetaxel Antineoplastic agents Carcinoma Lung neoplasms Surveys and questionnaires