ESMO 2025 | NIAGARA: HRQoL outcomes of perioperative durvalumab in MIBC

The NIAGARA, which is a phase three large study that randomized over a thousand patients with muscle-invasive bladder cancer to receive either cisplatin gemcitabine or cisplatin gemcitabine plus perioperative durvalumab. So previously we had already shown that event-free survival and overall survival were statistically significantly improved with the combination with perioperative Durvalumab, which was already published and has become standard of care in many countries around the world. So in this study, we looked at health-related quality of life, which was assessed by patient-reported electronic devices during the study and had pretty good compliance with around 80% of patients completing at least baseline and post-treatment assessment. What we found is that within this treatment in the neoadjuvant period, so all patients received cisplatin-based chemotherapy, and in this neoadjuvant period, we saw a significant reduction in global health status, physical functioning, and an increase in fatigue and also pain, especially around the cystectomy period. In the adjuvant period, so after cystectomy, when patients in the experimental arm were still receiving durvalumab, patients returned to baseline, so it seems that the reduction in quality of life mainly occurs during this neoadjuvant phase when patients receive chemotherapy. There was no difference between the two arms, so perioperative Durvalumab did not negatively impact quality of life in this setting.

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