The programmed death-1 (PD-1) inhibitor nivolumab prolongs disease-free survival in patients with muscle-invasive urothelial carcinoma (MIUC).
To evaluate the effects of nivolumab on health-related quality of life (HRQoL) after radical resection in patients with MIUC.
We used data from 709 patients in CheckMate 274 (NCT02632409; 282 with programmed death ligand 1 [PD-L1] expression ≥1%), an ongoing randomized, double-blind, placebo-controlled phase 3 trial of adjuvant nivolumab.
Intravenous injection of nivolumab (240 mg) or placebo every 2 wk for ≤1 yr.
HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EQ-5D-3L. Linear mixed-effect models for repeated measures were used to compare nivolumab and placebo on changes in HRQoL. Time to confirmed deterioration (TTCD) of HRQoL was analyzed by Cox proportional hazards regression.
In the full HRQoL evaluable population, no clinically meaningful deterioration of HRQoL was observed in either treatment arm. Moreover, nivolumab was noninferior to placebo on changes from baseline for all main outcomes. The median TTCD for fatigue was 41.0 wk for nivolumab and 44.3 wk for placebo (hazard ratio [HR]: 1.11, 95% confidence interval [CI], 0.89-1.39). For the visual analog scale, the median TTCD was not reached for nivolumab and it was 57.6 wk for placebo (HR: 0.78, 95% CI, 0.61-1.00). The median TTCD for the other main outcomes was not reached in either treatment arm. The findings were similar for patients with PD-L1 expression ≥1%.
These results demonstrate that nivolumab did not compromise the HRQoL of patients with MIUC in CheckMate 274.
Nivolumab is being researched as a new treatment for patients with bladder cancer (urothelial carcinoma). We found that nivolumab maintained quality of life while increasing the time until cancer returns in patients whose bladder cancer had spread or grown and who had unsuccessfully tried platinum-containing chemotherapy.
European urology oncology. 2022 Mar 11 [Epub ahead of print]
Johannes Alfred Witjes, Matthew D Galsky, Jürgen E Gschwend, Edward Broughton, Julia Braverman, Federico Nasroulah, Mario Maira-Arce, Xiaomei Ye, Ling Shi, Shien Guo, Melissa Hamilton, Dean F Bajorin
Radboud University, Nijmegen, The Netherlands. Electronic address: ., Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Technical University of Munich, Munich, Germany., Bristol Myers Squibb, Princeton, NJ, USA., Evidera, Waltham, MA, USA., Memorial Sloan Kettering Cancer Center, New York, NY, USA.