Nature Reviews Clinical Oncology ( IF 78.8 ) Pub Date : 2024-04-29 , DOI: 10.1038/s41571-024-00901-2 Peter Sidaway
Adjuvant therapy with the anti-PD-1 antibody pembrolizumab has been shown to significantly improve disease-free survival (DFS) relative to placebo in patients with resected nonmetastatic intermediate-to-high-risk renal cell carcinoma (RCC) in the phase III KEYNOTE-564 trial. Now, an update from this trial confirms that pembrolizumab also improves overall survival (OS).
A total of 994 patients were randomly allocated (1:1) to receive either pembrolizumab or placebo. OS was a secondary end point. A statistically significant improvement in DFS (the primary end point) was previously demonstrated at a cutoff of 24 months.
中文翻译:
辅助帕博利珠单抗可改善肾细胞癌患者的总生存期
在 III 期临床试验中,抗 PD-1 抗体派姆单抗辅助治疗已被证明相对于安慰剂可显着改善已切除的非转移性中高危肾细胞癌 (RCC) 患者的无病生存期 (DFS) -564审判。现在,该试验的最新进展证实,pembrolizumab 还可以改善总生存期 (OS)。
共有 994 名患者被随机分配 (1:1) 接受派姆单抗或安慰剂治疗。 OS 是次要终点。先前在 24 个月的截止时间证明了 DFS(主要终点)具有统计学上的显着改善。