Impact of Nivolumab Versus Docetaxel on Health-Related Quality of Life and Symptoms in Patients With Advanced Squamous Non-Small Cell Lung Cancer: Results From the CheckMate 017 Study.

In the phase III CheckMate 017 study, nivolumab prolonged overall survival versus docetaxel in previously treated patients with advanced squamous non-small cell lung cancer (NSCLC). Study objectives included health-related quality of life (HRQoL) and symptom assessments.Patients serially completed Lung Cancer Symptom Scale (LCSS) and European Quality of Life Five Dimensions (EQ-5D) questionnaires. The LCSS average symptom burden index (ASBI; mean score for six lung cancer-specific symptoms; range, 0-100), LCSS 3-item global index, EQ-5D utility index, and EQ-5D visual analog scale scores were analyzed. The proportion of patients exhibiting clinically meaningful improvement (≥10-point decrease) in ASBI scores by week 12 was a secondary end point. Mixed-effect model repeated measures analysis of HRQoL changes from baseline and analyses of time to HRQoL deterioration were conducted.Baseline mean (SD) LCSS ASBI scores were similar in nivolumab (29.6 [16.4]) and docetaxel (29.6 [14.7]) groups. By week 12, the proportion of patients (95% CI) with clinically meaningful improvement in ASBI scores was 20.0% (13.6-27.7) with nivolumab and 21.9% (15.3-29.8) with docetaxel. At weeks 16-54, significant improvements in ASBI scores from baseline were seen with nivolumab; clinically meaningful improvements were observed at weeks 42-84. No significant changes in ASBI scores from baseline were observed with docetaxel; at week 36, a clinically meaningful deterioration was seen. Improvements in HRQoL with nivolumab versus docetaxel were supported by other measures, and time to first HRQoL deterioration was longer.Nivolumab alleviates symptom burden and improves health status versus docetaxel as second-line squamous NSCLC treatment.