Abstract
BACKGROUND: In the phase III CheckMate 901 trial, nivolumab plus standard-of-care gemcitabine-cisplatin chemotherapy followed by nivolumab monotherapy significantly prolonged overall survival and progression-free survival versus gemcitabine-cisplatin alone in cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma (UC). Here, using patient-reported outcome (PRO) data from CheckMate 901, we report effects of adding nivolumab to gemcitabine-cisplatin on health-related quality of life (HRQoL). PATIENTS AND METHODS: PRO assessments [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EuroQol 5-Dimension 5-Level (EQ-5D-5L)] were scheduled for both arms through the first 6 months of treatment (combination phase), and for the nivolumab plus gemcitabine-cisplatin arm thereafter (monotherapy phase). The prespecified primary PRO scale of interest was QLQ-C30 global health status/quality of life (QoL). Secondary scales of interest included QLQ-C30 physical functioning, role functioning, and fatigue, and the EQ-5D-5L visual analog scale. Noninferiority analysis involved a mixed-effect model for repeated measures to estimate differences in least-squares mean changes from baseline to week 16. The proportions of patients with meaningful changes were calculated using prespecified thresholds. RESULTS: In total, 524 patients were analyzed (nivolumab plus gemcitabine-cisplatin, n = 276; gemcitabine-cisplatin alone, n = 248). Overall least-squares mean changes through week 16 indicated the noninferiority of nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone for global health status/QoL and all secondary scales. At week 16, the proportions of patients with meaningful changes in global health status/QoL (improvement, 29.2% versus 23.0%; deterioration, 28.3% versus 30.4%) and all secondary PRO scales were similar in both arms. CONCLUSIONS: Adding nivolumab to gemcitabine-cisplatin did not worsen HRQoL compared with gemcitabine-cisplatin alone in the first 16 weeks of therapy. These findings support nivolumab plus gemcitabine-cisplatin as standard first-line therapy for cisplatin-eligible patients with unresectable or metastatic UC.