This study is part of the SNPs in Nivolumab PD-1 inhibitor for RCC (SNiP-RCC). Here we aimed to reveal clinical factors for tumor response, progression, and survival in nivolumab for advanced clear cell renal cell carcinoma (RCC) in Japanese patients.
We included patients from 23 institutions in Japan. We evaluated the objective response, radiographic progression-free survival (PFS), overall survival (OS), and treatment-related grade ≥ 3 (serious adverse events [SAEs]).
We included 222 patients. The median age was 69 years (interquartile range 62-74 years), and 71% of the patients were male. Pancreas metastasis, lung metastases, prior cytokine therapy, and SAEs, were associated with objective response. The median PFS was 18 months. Liver metastases (hazard ratio [HR], 1.61), age ≥ 75 (HR, 0.48), previous resection of primary sites (HR, 0.47), and SAEs (HR, 0.47) were independent prognostic factors for PFS. Karnofsky Performance Status <70 (HR, 2.90), high platelets (HR, 4.48), previous resection of primary sites (HR, 0.23), and pathological grade (HR, 0.19 for grade 2 and HR, 0.12 for grade 3) were independent prognostic factors for OS. SAEs were reported in 45 (20.3%) cases. In the group of patients with prior nephrectomy, SAEs were associated with objective response, PFS, and OS.
The SNiP-RCC study identified clinical parameters correlated with treatment outcomes in Japanese patients with priorly treated advanced clear cell RCC undergoing nivolumab monotherapy.
International journal of urology : official journal of the Japanese Urological Association. 2023 Aug 01 [Epub ahead of print]
Leandro Blas, Masaki Shiota, Hideaki Miyake, Masayuki Takahashi, Mototsugu Oya, Norihiko Tsuchiya, Naoya Masumori, Hideyasu Matsuyama, Wataru Obara, Nobuo Shinohara, Kiyohide Fujimoto, Masahiro Nozawa, Kojiro Ohba, Chikara Ohyama, Katsuyoshi Hashine, Shusuke Akamatsu, Tomomi Kamba, Koji Mita, Momokazu Gotoh, Shuichi Tatarano, Masato Fujisawa, Yoshihiko Tomita, Shoichiro Mukai, Keiichi Ito, Tokiyoshi Tanegashima, Shoji Tokunaga, Masatoshi Eto, SNiP-RCC Investigators
Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan., Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan., Department of Urology, Keio University School of Medicine, Tokyo, Japan., Department of Urology, Faculty of Medicine, Yamagata University, Yamagata, Japan., Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan., Department of Urology, Graduate School of Medicine, Yamaguchi University, Ube, Japan., Department of Urology, Iwate Medical University School of Medicine, Morioka, Japan., Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan., Department of Urology, Nara Medical University, Kashihara, Japan., Department of Urology, Kindai University Faculty of Medicine, Osakasayama, Japan., Department of Urology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan., Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan., Department of Urology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan., Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan., Department of Urology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan., Department of Urology, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan., Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan., Department of Urology, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan., Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan., Department of Urology and Molecular Oncology, Graduate School of Medicine and Dental Sciences, Niigata University, Niigata, Japan., Department of Urology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan., Department of Urology, National Defense Medical College, Saitama, Japan., Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.