J Clin Oncol:瑞派替尼 vs 舒尼替尼后线治疗晚期胃肠道间质瘤

2022-08-12 MedSci原创 MedSci原创

在临床活性、不良反应和耐受性方面,瑞派替尼均优于舒尼替尼

舒尼替尼是一种多靶点酪氨酸激酶抑制剂 (TKI) ,已获批用于经伊马替尼治疗失败的晚期胃肠道间质瘤(GIST)。瑞派替尼是一种开关控制型 TKI,获批用于使用三种或更多 TKI(包括伊马替尼)治疗后的晚期 GIST。

该研究旨在比较瑞派替尼与舒尼替尼在既往接受过伊马替尼治疗的晚期 GIST 患者中的疗效和安全性。

接受过伊马替尼治疗的晚期 GIST 患者被随机(1:1)分至瑞派替尼(150 mg,口服,1/日)舒尼替尼(50 mg,口服,1/日),连服4周,停两周;并根据KITI 血小板来源生长因子α突变和伊马替尼耐受性进行分层。主要终点是意向治疗人群(ITT)的无进展生存期(PFS)。次要终点包括客观缓解率、安全性和患者报告的预后。


两组KIT 外显子11 ITT人群和ITT人群的PFS率

总体上,共453位患者被随机分至瑞派替尼组(ITT:n=226;KIT 外显子11 ITT:n=164)或舒尼替尼组(ITT:n=227;KIT 外显子11 ITT:n=164)。瑞派替尼组和舒尼替尼组(KIT 外显子11 ITT)的中位PFS分别是8.3个月和7.0个月(HR 0.88,p=0.36);中位PFS(ITT)分别是8.0个月和8.3个月(HR 1.05,p=0.72)。均无统计学意义。

在KIT 外显子11 ITT人群中,瑞派替尼组患者的客观缓解率高于舒尼替尼组(23.9% vs 14.6%,p=0.03)。瑞派替尼有更好的安全谱,3/4级治疗相关不良反应的发生率更低(41.3% vs 65.6%,p<0.0001),而且患者报告的耐受性预后评分也更好。

总之,在晚期胃肠道间质瘤患者的无进展生存期方面,瑞派替尼未表现出优于舒尼替尼的特性。但是,在临床活性、不良反应和耐受性方面,瑞派替尼均优于舒尼替尼。

原始出处:

Sebastian Bauer, et al. Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial. Journal of Clinical Oncology. August 10, 2022. https://ascopubs.org/doi/full/10.1200/JCO.22.00294

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    2022-11-15 minlingfeng
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