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一线双重免疫检查点抑制剂治疗与包含免疫检查点抑制剂和酪氨酸激酶抑制剂的联合治疗方案用于晚期肾细胞癌:使用真实世界数据的有效性比较分析。

First-line dual immune checkpoint inhibitor therapies versus combination therapies comprising immune checkpoint inhibitors and tyrosine kinase inhibitors for advanced renal cell carcinoma: a comparative analysis of the effectiveness using real-world data.

机构信息

Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-Cho, Shinjuku-Ku, Tokyo, Japan.

Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University Hospital, 1 Hikarigaoka, Fukushima, Fukushima, Japan.

出版信息

Int J Clin Oncol. 2024 Apr;29(4):473-480. doi: 10.1007/s10147-024-02471-w. Epub 2024 Feb 12.

DOI:10.1007/s10147-024-02471-w
PMID:38345708
Abstract

BACKGROUND

There are few comparative studies on dual immune checkpoint inhibitors (ICIs) (i.e., IO-IO) and combination therapies comprising ICIs plus tyrosine kinase inhibitors (TKIs) (i.e., IO-TKI) for advanced renal cell carcinoma (RCC), especially in real-world settings.

METHODS

We retrospectively evaluated data of 175 patients with IMDC intermediate-risk or poor-risk RCC; as first-line therapy, 103 received IO-IO, and 72 received IO-TKI. An inverse probability of treatment weighting (IPTW) analysis was conducted to balance patients' backgrounds in the IO-IO and IO-TKI groups.

RESULTS

Based on the IPTW analysis, progression-free survival (PFS) was longer in the IO-TKI group than in the IO-IO group (median: 15.6 vs. 8.3 months; p = 0.0386). In contrast, overall survival was not different between groups (median: 46.7 vs. 49.0 months; p = 0.465). Although the IPTW-adjusted objective response rate was not significantly different (51.2% vs. 43.9%; p = 0.359), the progressive disease rate as the best overall response was lower in the IO-TKI group than in the IO-IO group (3.3% vs. 27.4%; p < 0.0001). Regarding the safety profile, the treatment interruption rate was higher in the IO-TKI group than in the IO-IO group (70.3% vs. 49.2%; p = 0.005). In contrast, the IO-IO group had a higher corticosteroid administration rate (43.3% vs. 20.3%; p = 0.001).

CONCLUSION

IO-TKI therapy exhibited superior effectiveness over IO-IO therapy in terms of PFS improvement and immediate disease progression prevention and was associated with a higher risk of treatment interruption and a lower risk of needing corticosteroids.

摘要

背景

在晚期肾细胞癌(RCC)的治疗中,针对双重免疫检查点抑制剂(ICI)(即 IO-IO)与包含 ICI 加酪氨酸激酶抑制剂(TKI)的联合疗法(即 IO-TKI),目前仅有为数不多的比较研究,特别是在真实世界环境中。

方法

我们回顾性评估了 175 例国际转移性肾细胞癌数据库联盟(IMDC)中危或高危 RCC 患者的数据;作为一线治疗,103 例患者接受 IO-IO,72 例患者接受 IO-TKI。采用逆概率治疗加权(IPTW)分析平衡 IO-IO 和 IO-TKI 两组患者的背景。

结果

基于 IPTW 分析,IO-TKI 组的无进展生存期(PFS)长于 IO-IO 组(中位数:15.6 个月 vs. 8.3 个月;p=0.0386)。相反,两组的总生存期无差异(中位数:46.7 个月 vs. 49.0 个月;p=0.465)。虽然 IPTW 调整后的客观缓解率无显著差异(51.2% vs. 43.9%;p=0.359),但 IO-TKI 组的最佳总体反应进展疾病率低于 IO-IO 组(3.3% vs. 27.4%;p<0.0001)。关于安全性概况,IO-TKI 组的治疗中断率高于 IO-IO 组(70.3% vs. 49.2%;p=0.005)。相反,IO-IO 组的皮质类固醇使用率较高(43.3% vs. 20.3%;p=0.001)。

结论

与 IO-IO 治疗相比,IO-TKI 治疗在改善 PFS 和立即预防疾病进展方面表现出更好的疗效,且与更高的治疗中断风险和更低的皮质类固醇需求相关。

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