免疫检查点抑制剂一线联合治疗转移性非透明细胞肾细胞癌的临床结果：日本的一项多机构回顾性研究。
Clinical outcomes of first-line combination therapy with immune checkpoint inhibitor for metastatic non-clear cell renal cell carcinoma: a multi-institutional retrospective study in Japan.
发表日期：2024 Sep 02
作者：
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
来源：
Immunity & Ageing
摘要：
在转移性透明细胞肾细胞癌（ccRCC）中，最近的研究表明免疫检查点抑制剂（ICI）联合疗法具有良好的疗效。然而，关于ICI联合疗法治疗转移性非ccRCC（nccRCC）的临床疗效和安全性证据不足。我们回顾性研究了44例接受纳武单抗加伊匹单抗（ICI ICI组）或抗PD-1/PD-L1抑制剂治疗的患者联合酪氨酸激酶抑制剂（TKI）（ICI TKI组），并评估两组临床疗效。所有患者中，ICI联合治疗的总有效率和疾病控制率分别为36.3%和75%。中位无进展生存期 (PFS) 和总生存期 (OS) 分别为 8.8 个月和 23.9 个月。多变量分析显示，肝转移的存在显着影响较差的 PFS 和 OS（p = 0.035 和 p = 0.049）。重要的是，ICI ICI组和ICI TKI组的PFS和OS似乎相似（p = 0.778和p = 0.559）。尽管年龄 ≥ 75岁的患者因不良反应而终止联合治疗的比率明显高于年龄 < 75岁的患者（45% vs 12%，p = 0.017），但PFS和PFS没有显着差异。两组之间的 OS（分别为 p = 0.290 和 p = 0.257）。本研究证实了 ICI 联合治疗在现实环境中对转移性 nccRCC 患者的临床益处。此外，就临床预后而言，联合治疗的有效性在 75 岁以下患者和 75 岁以上患者之间具有可比性。© 2024。作者。
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.© 2024. The Author(s).