Prognostic Impact of Immune-Related Adverse Events as First-Line Therapy for Metastatic Renal Cell Carcinoma Treated With Nivolumab Plus Ipilimumab: A Multicenter Retrospective Study.

Immune checkpoint inhibitors can cause various immune-related adverse events (irAEs). This study aimed to evaluate the association between the incidence of irAEs and oncological outcomes of metastatic renal cell carcinoma (mRCC) treated with nivolumab plus ipilimumab as first-line therapy.

We retrospectively analyzed data from 69 patients with mRCC treated with nivolumab plus ipilimumab as first-line therapy between September 2018 and September 2021 at 4 institutions. Cox regression analyses were performed to investigate the important factors affecting overall survival (OS) in patients with mRCC treated with nivolumab plus ipilimumab as first-line therapy.

During observation with a median follow-up of 9.1 months, the median OS was not reached, while the median progression-free survival was 6.0 months. Patients with irAEs had significantly prolonged OS and progression-free survival than those without irAEs (p = .012 and .002, respectively). Multivariate analysis showed that 3 independent factors, including C-reactive protein (CRP), irAEs, and performance status (PS), were significantly associated with OS (p = .04, .02, and .01, respectively). The patients were subsequently divided into 3 groups as follows: group 1, 20 patients with all 3 independent OS predictors; group 2, 18 patients with irAE predictors alone or 2 positive independent OS predictors (irAEs + CRP or irAEs + PS); group 3, 31 patients with 3 negative independent S predictors. OS varied significantly among the 3 groups (p = .004).

The appearance of irAEs could predict OS in patients with mRCC treated with nivolumab plus ipilimumab as the first-line therapy.

Clinical genitourinary cancer. 2023 Oct 01 [Epub ahead of print]

Takuhisa Nukaya, Kiyoshi Takahara, Atsuhiko Yoshizawa, Masanobu Saruta, Yusuke Yano, Takaya Ohno, Taizo Uchimoto, Wataru Fukuokaya, Takahiro Adachi, Shogo Yamazaki, Satoshi Tokushige, Kazuki Nishimura, Takuya Tsujino, Keita Nakamori, Shutaro Yamamoto, Kosuke Iwatani, Fumihiko Urabe, Keiichiro Mori, Takafumi Yanagisawa, Shunsuke Tsuduki, Yosuke Hirasawa, Takeshi Hashimoto, Kazumasa Komura, Teruo Inamoto, Jun Miki, Takahiro Kimura, Yoshio Ohno, Haruhito Azuma, Ryoichi Shiroki

Department of Urology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan., Department of Urology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.. Electronic address: ., Department of Urology, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan., Department of Urology, The Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Tokyo Medical University, Tokyo, Japan.