Blas Leandro, Shiota Masaki, Miyake Hideaki, Takahashi Masayuki, Oya Mototsugu, Tsuchiya Norihiko, Masumori Naoya, Matsuyama Hideyasu, Obara Wataru, Shinohara Nobuo, Fujimoto Kiyohide, Nozawa Masahiro, Ohba Kojiro, Ohyama Chikara, Hashine Katsuyoshi, Akamatsu Shusuke, Kamba Tomomi, Mita Koji, Gotoh Momokazu, Tatarano Shuichi, Fujisawa Masato, Tomita Yoshihiko, Mukai Shoichiro, Ito Keiichi, Tanegashima Tokiyoshi, Tokunaga Shoji, Eto Masatoshi
Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Int J Urol. 2023 Sep;30(9):788-796. doi: 10.1111/iju.15265. Epub 2023 Aug 1.
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.
本研究是纳武单抗PD - 1抑制剂用于肾细胞癌（SNiP - RCC）的单核苷酸多态性研究的一部分。在此，我们旨在揭示日本晚期透明细胞肾细胞癌（RCC）患者使用纳武单抗治疗时肿瘤反应、进展及生存的临床因素。
我们纳入了来自日本23家机构的患者。评估了客观缓解率、影像学无进展生存期（PFS）、总生存期（OS）以及治疗相关的≥3级（严重不良事件[SAEs]）。
我们纳入了222例患者。中位年龄为69岁（四分位间距62 - 74岁），71%的患者为男性。胰腺转移、肺转移、既往细胞因子治疗以及严重不良事件与客观缓解相关。中位PFS为18个月。肝转移（风险比[HR]，1.61）、年龄≥75岁（HR，0.48）、原发部位既往切除史（HR，0.47）以及严重不良事件（HR，0.47）是PFS的独立预后因素。卡诺夫斯基体能状态<70（HR，2.90）、高血小板计数（HR，4.48）、原发部位既往切除史（HR，0.23）以及病理分级（2级HR，0.19；3级HR，0.12）是OS的独立预后因素。45例（20.3%）患者报告了严重不良事件。在既往接受过肾切除术的患者组中，严重不良事件与客观缓解、PFS和OS相关。
SNiP - RCC研究确定了与接受纳武单抗单药治疗的既往治疗过的日本晚期透明细胞RCC患者治疗结果相关的临床参数。
