In metastatic clear cell renal cell carcinoma (ccRCC), recent studies have shown promising efficacy of immune checkpoint inhibitor (ICI) combination therapy. However, there are insufficient evidences about clinical efficacy and safety of ICI combination therapy in metastatic non-ccRCC (nccRCC).
We retrospectively investigated 44 patients treated with nivolumab plus ipilimumab (ICI + ICI group) or anti-PD-1/PD-L1 inhibitor plus tyrosine kinase inhibitors (TKI) (ICI + TKI group), and assessed clinical efficacy in both groups.
Of all patients, overall response rate and disease control rate for ICI combination treatments were 36.3% and 75%, respectively. The median progression-free survival (PFS) and overall survival (OS) was 8.8 and 23.9 months, respectively. Multivariate analysis revealed that the presence of liver metastasis significantly affected worse PFS and OS (p = 0.035 and p = 0.049). Importantly, PFS and OS seemed similar in ICI + ICI group and ICI + TKI group (p = 0.778 and p = 0.559). Although the discontinuation rate of the combination therapy due to adverse effects in patients aged ≥ 75 years was significantly higher compared to that in patients aged < 75 years (45% versus 12%, p = 0.017), there were no significant differences in PFS and OS between two groups (p = 0.290 and p = 0.257, respectively).
This study confirms clinical benefit of ICI combination therapy for metastatic nccRCC patients in real-world settings. Furthermore, the effectiveness of combination therapy was comparable between patients aged < 75 and those ≥75 years with respect to clinical prognosis.
International journal of clinical oncology. 2024 Sep 02 [Epub ahead of print]
Akihiro Yoshimura, Taigo Kato, Yasutomo Nakai, Masao Tsujihata, Shingo Toyoda, Mototaka Sato, Kyosuke Matsuzaki, Wataru Nakata, Tetsuya Takao, Syunsuke Inoguchi, Yohei Okuda, Gaku Yamamichi, Yu Ishizuya, Yoshiyuki Yamamoto, Koji Hatano, Atsunari Kawashima, Shingo Takada, Hitoshi Inoue, Kensaku Nishimura, Osamu Miyake, Kazutoshi Fujita, Masashi Nakayama, Kazuo Nishimura, Norio Nonomura
Departments of Urology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan., Departments of Urology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. ., Department of Urology, Osaka International Cancer Institute, Osaka, Japan., Department of Urology, Osaka Rosai Hospital, Sakai, Japan., Department of Urology, Kindai University Hospital, Osakasayama, Japan., Department of Urology, Toyonaka Municipal Hospital, Toyonaka, Japan., Department of Urology, Osaka National Hospital, Osaka, Japan., Department of Urology, Ikeda City Hospital, Ikeda, Japan., Department of Urology, Osaka General Medical Center, Osaka, Japan., Department of Urology, Osaka Police Hospital, Osaka, Japan.