JAMA子刊:二线免疫治疗在肾癌随机对照试验中的应用

2021-10-29 MedSci原创 MedSci原创

联合免疫治疗方案的临床益处可能被高估了。

在一线酪氨酸激酶抑制剂(TKI)治疗取得进展后,免疫治疗就与改善晚期肾细胞癌(KCC)的生存率密切相关了。在比较一线晚期KCC患者的联合免疫治疗方案与TKI的试验中,对照组患者是否接受以及在多大程度上接受了免疫治疗尚不清楚。

为了描述联合免疫治疗方案与TKI治疗一线晚期肾细胞癌的试验中对照组接受免疫治疗的比例。研究者在PubMed上搜索了治疗一线晚期KCC的临床试验,在201511日至2021228日期间发布的文章中,把使用1种免疫治疗剂和附加免疫治疗剂或TKI的联合免疫治疗方案与一线治疗药物舒尼替尼的做对比。然后分析已发表的文章、方案和补充材料。

联合免疫治疗方案与TKI治疗一线晚期肾细胞癌试验的方案后免疫治疗给药特点

虽然在进行的6项试验中,文章发表时均未达到中位OS5年生存率),但仍有4项试验报告了联合免疫治疗与OS的统计学显著改善相关。可以看到在KEYNOTE-426CheckMate214的对比上,OS风险比说明联合免疫治疗效果更好术后免疫治疗的低使用率提出了一个问题,即观察到的一些OS益处可能是由于对照组的术后免疫治疗不理想,而不是通过前期联合治疗获得更好的疗效。

随机接受舒尼替尼对照治疗的患者的治疗状况

在有限的治疗方法下,晚期肾细胞癌仍然是一种具有挑战性的疾病。虽然在最近的联合免疫治疗方案与TKI舒尼替尼的试验的初步比较研究中报告了阳性结果,但这些数据的解释必须根据对照组患者适当的免疫治疗率来进行。对照组中接受经证实具有死亡率优势的术后免疫治疗的患者比例较低。于是产生了一个问题:与对照组缺乏术后免疫治疗相比,一线联合免疫治疗方案的益处在多大程度上与联合方案的较好疗效相关?因此,联合免疫治疗方案的临床益处可能被高估了。

参考文献:John Sharp, MD; Ali Raza Khaki, MD, MS; Vinay Prasad, MD, MPH. Use of Second-line Immunotherapy in Control Arms of Randomized Clinical Trials in Kidney Cancer A Systematic Review.JAMA Network Open. 2021;4(9):e2124728. doi:10.1001/jamanetworkopen.2021.24728.

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