Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC

In the randomized phase 2/3 KEYNOTE-010 study (NCT01905657), pembrolizumab significantly prolonged OS compared with docetaxel in previously treated, PD-L1–positive (tumor proportion score [TPS] ≥1% and ≥50%), advanced NSCLC. Here, we report HRQoL findings from KEYNOTE-010. Patients (pts) with PD-L1–positive NSCLC who progressed after platinum-based chemotherapy were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg Q3W or docetaxel 75 mg/kg. HRQoL was assessed using eEORTC QLQ-C30, QLQ-LC13, and eEuroQoL-5D. Analyses included mean change from baseline to wk 12 in global QoL score, functioning and symptom domains; and time to deterioration in a QLQ-LC13 composite end point of cough, dyspnea, and chest pain. Compliance was >90% at baseline and >80% at wk 12. Pts in the pembrolizumab arms (n = 131, 2 mg/kg; n = 145,10 mg/kg) reported either a numerical improvement in or less decrement of QLQ-C30 global QoL score from baseline to wk 12 versus docetaxel (n = 125); the difference in least-squares means at wk 12 was statistically significant (8.3 [95% CI, 2.42-14.26]; P = 0.006) for pembrolizumab 2 mg/kg compared with docetaxel in the PD-L1 TPS ≥50% stratum. Changes from baseline in EORTC functioning and symptom domains were numerically superior for pembrolizumab versus docetaxel; fatigue, insomnia, dyspnea, hemoptysis, alopecia, peripheral neuropathy, and sore mouth reached statistical significance. Pembrolizumab also had a smaller proportion of “deteriorated” status and a larger proportion of “stable” and “improved” status for QLQ-C30 global QoL and functional and symptom scales versus docetaxel. Pembrolizumab increased time to true deterioration in the QLQ-LC13 composite end point; statistical significance was achieved for the pembrolizumab 2 mg/kg, TPS ≥50% stratum (HR, 0.68 [95% CI, 0.48-0.96]; P = 0.030 vs docetaxel). 12-wk EQ-5D visual analog scale analyses were consistent with the results of QLQ-C30 analyses. Pembrolizumab improved HRQoL and prolonged time to deterioration of lung cancer symptom scores compared with docetaxel.