In this abstract, the authors investigate in depth the effect of NIVO vs PBO on health-related quality of life (HRQoL). HRQoL was assessed during and after treatment using the EORTC QLQ C30 and EQ-5D-3L. The HRQoL analysis included all patients with valid HRQoL assessments at baseline and at ≥1 post-baseline visit. 5 relevant domains (see Table) were pre-specified as the main HRQoL outcomes based on their relevance to the patient population. Pre-specified margins were used to determine non-inferiority of NIVO vs PBO. Time to confirmed deterioration (TCD) in HRQoL (worsening above an a priori threshold at ≥2 consecutive visits) was compared between treatments by multivariable stratified Cox regression.
Jumping to the results, the HRQoL analysis included 324 patients randomized to NIVO (PD L1 ≥1%: n=123) and 321 patients randomized to PBO (PD-L1 ≥1%: n=128). The breakdown flow chart is seen here:
In terms of demographics, the median age of patients included in the HRQoL analysis was 67 years, and 76% were male.
The full demographics of the study are seen here:
Completion rates for HRQoL assessments were >85% across all visits during treatment in both arms.
HRQoL was maintained over time in both arms; NIVO was non-inferior to PBO for all domains (see Table). 
- Risk of confirmed deterioration for the EQ-5D visual analogue scale (VAS) showed a trend of being lower for NIVO than for PBO (all patients: hazard ratio [HR] 0.78, 95% CI 0.61-1.00, P=0.052; PD L1 ≥1%: HR 0.63, 95% CI 0.42-0.93, P=0.021).
TCD for other domains was comparable between treatments. This can be seen on the curves as below:
For other outcomes, trends in patients with PD-L1 ≥1% were similar to those for all patients.
Based on this they concluded that HRQoL in MIBC patients treated with NIVO was non-inferior to patients treated with PBO. Taken together with earlier clinical evidence, these results demonstrate that NIVO prolonged DFS without compromising HRQoL.
Presented by: Prof. Dr. Jürgen Gschwend, MD, PhD, Professor of Urology, TUM School of Medicine, Technical Univeristy of Munich, Germany
Written by: Thenappan (Thenu) Chandrasekar, MD – Urologic Oncologist, Assistant Professor of Urology, Sidney Kimmel Cancer Center, Thomas Jefferson University, @tchandra_uromd on Twitter during the 2021 European Association of Urology, EAU 2021- Virtual Meeting, July 8-12, 2021.
References:
1. Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442. PMID: 34077643; PMCID: PMC8215888.