Ishihara Hiroki, Nemoto Yuki, Tachibana Hidekazu, Ikeda Takashi, Fukuda Hironori, Yoshida Kazuhiko, Kobayashi Hirohito, Iizuka Junpei, Shimmura Hiroaki, Hashimoto Yasunobu, Kondo Tsunenori, Takagi Toshio
Department of Urology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan.
Department of Urology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan; Department of Urology, Tokyo Women's Medical University Adachi Medical Center, Adachi-ku, Tokyo, Japan; Department of Urology, Saiseikai Kawaguchi General Hospital, Kawaguchi, Saitama, Japan.
Clin Genitourin Cancer. 2024 Apr;22(2):549-557.e5. doi: 10.1016/j.clgc.2024.01.010. Epub 2024 Jan 15.
It remains unclear whether kidney function affects outcomes following immune checkpoint inhibitor (ICI)-based combination therapy for advanced renal cell carcinoma (RCC).
We retrospectively evaluated data of 167 patients with advanced RCC, including 98 who received ICI dual combination therapy (ie, immunotherapy [IO]-IO) and 69 who received ICI combined with tyrosine kinase inhibitor (TKI) (ie, IO-TKI). In each regimen, treatment profiles were assessed according to the grade of chronic kidney disease (CKD) as defined by the KDIGO 2012 criteria.
Of the 98 patients who received IO-IO, 31 (32%), 30 (31%), 15 (15%), and 22 (22%) had CKD G1/2, G3a, G3b, and G4/5, respectively. Of the 69 patients who received IO-TKI, 18 (26%), 25 (36%), and 26 (38%) had G1/2, G3a, and G3b/4/5, respectively. Regarding efficacy, progression-free survival, overall survival, or objective response rate was not different according to the CKD grade in both treatment groups (P > .05). Regarding safety, the rate of adverse events, treatment interruption, or corticosteroid administration was not different according to the CKD grade in the IO-IO group (P > .05), whereas in the IO-TKI group, the incidence of grade ≥ 3 adverse events were significantly higher (P = .0292), and the rates of ICI interruption (P = .0353) and corticosteroid administration (P = .0685) increased, according to the CKD grade.
There is a differential safety but comparable efficacy profile between the IO-IO and IO-TKI regimens in patients with CKD. Further prospective studies are required to confirm these findings.
对于晚期肾细胞癌(RCC)患者,基于免疫检查点抑制剂(ICI)的联合治疗中,肾功能是否会影响治疗结果仍不清楚。
我们回顾性评估了167例晚期RCC患者的数据,其中98例接受了ICI双联联合治疗(即免疫疗法[IO]-IO),69例接受了ICI联合酪氨酸激酶抑制剂(TKI)(即IO-TKI)。在每种治疗方案中,根据KDIGO 2012标准定义的慢性肾脏病(CKD)分级评估治疗情况。
在接受IO-IO治疗的98例患者中,分别有31例(32%)、30例(31%)、15例(15%)和22例(22%)患有CKD G1/2、G3a、G3b和G4/5。在接受IO-TKI治疗的69例患者中,分别有18例(26%)、25例(36%)和26例(38%)患有G1/2、G3a和G3b/4/5。关于疗效,两个治疗组中,根据CKD分级,无进展生存期、总生存期或客观缓解率均无差异(P>.05)。关于安全性,IO-IO组中,根据CKD分级,不良事件发生率、治疗中断率或皮质类固醇给药率无差异(P>.05),而在IO-TKI组中,≥3级不良事件的发生率显著更高(P=.0292),并且根据CKD分级,ICI中断率(P=.0353)和皮质类固醇给药率(P=.0685)增加。
CKD患者中,IO-IO和IO-TKI治疗方案之间存在不同的安全性,但疗效相当。需要进一步的前瞻性研究来证实这些发现。