ICI-Based Urologic Cancer Therapies Tied to High Adverse Event Rates

Treatment-related adverse events of any grade develop in the majority of patients who receive urologic cancer therapies based on immune checkpoint inhibitors, according to a study.

Urologic cancer treatments based on immune checkpoint inhibitors (ICIs) are associated with a high incidence of adverse effects (AEs), according to investigators.

In a meta-analysis of data from 92 clinical trials involving 22,942 participants, the pooled overall incidence of treatment-related AEs was 81.6% for AEs of any grade and 29.3% for grade 3 or higher AEs, corresponding authors Le Qu, MD, of Jinling Hospital, Clinical School of Medical College, Nanjing University, Nanjing, China, and Mingmin Li, MD, of Changhai Hospital, Naval Medical University, Shanghai, China, and colleagues reported in European Urology. The pooled overall incidence of immune-related AEs was 34.3% and 10.2% for those of any grade and grade 3 or higher AEs, respectively.

The incidence varied by cancer type. For example, the incidence of any-grade treatment-related AEs was 88.3%, 81.4%, and 74.6% among patients with kidney, prostate, and urothelial cancers, respectively. The incidence of any-grade immune-related AEs was 48.3%, 42.7%, and 24.9% among patients with prostate, kidney, and urothelial cancers, respectively.

On multivariable analysis, cancer type, therapy combination, clinical setting (eg, perioperative vs advanced/metastatic disease), and drug exposure were independently associated with development of treatment- and immune-related AEs.

The highest incidence of treatment-related AEs occurred among patients with kidney cancer, who had an 88.3% incidence of AEs of any grade and 36.1% incidence of grade 3 or higher AEs. Patients with prostate cancer had the highest incidence of immune-related AEs: 48.3% for any-grade AEs and 17.6% for grade 3 or higher AEs.

The overall rate of treatment-related mortality was 0.94%, the most common causes being pneumonitis (9.3% of deaths), pneumonia (7.9%), and respiratory failure (7.1%).

Immune-related mortality occurred in 0.26% of patients, the most common causes of which were pneumonitis (35.7%), hepatic failure (10.7%), and hepatitis (7.1%).

“Our study provides a comprehensive overview of ICI-associated AEs in urologic cancer patients,” the investigators concluded. “The spectrum and incidence of AEs vary across cancer types, ICI types, clinical settings, and therapy combinations. These findings provide important guidance to clinicians in counseling and management of patients with urologic cancers.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Wu Z, Chen Q, Qu L et al. Adverse events of immune checkpoint inhibitors therapy for urologic cancer patients in clinical trials: A collaborative systematic review and meta-analysis. Eur Urol. Published online January 28, 2022. doi:10.1016/j.eururo.2022.01.028

This article originally appeared on Renal and Urology News