Iinuma Koji, Yamada Toyohiro, Kameyama Koji, Taniguchi Tomoki, Kawada Kei, Ishida Takashi, Nagai Shingo, Enomoto Torai, Ueda Shota, Takagi Kimiaki, Kawase Makoto, Takeuchi Shinichi, Kawase Kota, Kato Daiki, Takai Manabu, Nakane Keita, Koie Takuya
Department of Urology, Graduate School of Medicine, Gifu University, Gifu 5011194, Japan.
Department of Urology, Central Japan International Medical Center, 1-1 Kenkonomachi, Minokamo 5058510, Japan.
Cancers (Basel). 2023 Feb 2;15(3):947. doi: 10.3390/cancers15030947.
We evaluated the efficacy and safety of combination therapy with immune checkpoint inhibitors (ICIs) and tyrosine kinase inhibitors (TKI) as first-line therapy for patients diagnosed as having advanced or metastatic renal cell carcinoma (mRCC). We enrolled 51 patients to receive ICI+TKI therapy for mRCC at 9 Japanese institutions. The overall survival (OS) of the patients treated with ICI+TKI was the primary endpoint., and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Furthermore, we analyzed the clinical prognostic and predictive factors in patients with mRCC treated with ICI+TKI therapy. Seven months was the median follow-up period. The OS rates at 6, 12, and 18 months were 93.1, 82.5, and 68.8%, respectively. The median PFS for patients who received ICI+TKI was 19.0 months, ORR was 68.6%, and DCR was 88.2%. ICI+TKI-related adverse events occurred in 43 patients (84.3%) with any grade and in 22 patients (43.1%) with grade ≥3. Treatment selection with poor prognostic factors may be prudent, even though ICI+TKI is an efficacious and safe first-line treatment in patients with mRCC.
我们评估了免疫检查点抑制剂（ICI）与酪氨酸激酶抑制剂（TKI）联合治疗作为晚期或转移性肾细胞癌（mRCC）患者一线治疗的疗效和安全性。我们在9家日本机构招募了51例接受ICI+TKI治疗mRCC的患者。接受ICI+TKI治疗患者的总生存期（OS）是主要终点，次要终点为无进展生存期（PFS）、客观缓解率（ORR）和疾病控制率（DCR）。此外，我们分析了接受ICI+TKI治疗的mRCC患者的临床预后和预测因素。中位随访期为7个月。6、12和18个月时的OS率分别为93.1%、82.5%和68.8%。接受ICI+TKI治疗患者的中位PFS为19.0个月，ORR为68.6%，DCR为88.2%。43例患者（84.3%）发生了任何级别的ICI+TKI相关不良事件，22例患者（43.1%）发生了≥3级不良事件。尽管ICI+TKI对mRCC患者是一种有效且安全的一线治疗，但对于具有不良预后因素的患者，治疗选择可能需要谨慎。
