Blood:Ixazomib显着延长复发性/难治性骨髓瘤患者的无进展生存期。

2017-10-23 qinqiyun MedSci原创

多发性骨髓瘤(MM)患者的显着特点是携带某些细胞遗传学异常。现3期TOURMALINE-MM1研究证明Ixazomib+来那度胺+地塞米松(IRd)的联合疗法比来那度胺+地塞米松(Rd)可显着延长患者无进展生存期(PFS)。

多发性骨髓瘤(MM)患者的显着特点是携带某些细胞遗传学异常。现3期TOURMALINE-MM1研究证明Ixazomib+来那度胺+地塞米松(IRd)的联合疗法比来那度胺+地塞米松(Rd)可显着延长患者无进展生存期(PFS)。

该预实验,根据细胞遗传学风险,通过免疫荧光原位杂交对IRd与Rd的疗效和安全性进行评估。携带del(17p)、t(4;14)和(或)t(14;16)的定义为高风险的细胞遗传学异常,此外,同时评估患者1q21的扩增情况。

共722位随机患者,其中552位具有细胞学结果;137位(25%)具有高风险的细胞遗传遗传,172位(32%)只携带1q21扩增。

与安慰组Rd相比,IRd可提高患者(包括细胞遗传异常高风险组/标准风险组)的PFS(对高风险的患者,危险比(HR)0.543[95% CI,0.321-0.918;p=0.021],PFS的中位值21.4 vs 9.7个月;对标准风险的患者HR 0.640[95% CI,0.462-0.888;p=0.007],PFS中位值 20.6 vs 15.6个月)。

PFS的疗效与个体高风险的细胞遗传异常相一致,包括携带del(17p)的患者(HR 0.596;95% CI,0.286-1.243)。对于1q21扩增的患者,IRd治疗也比Rd治疗显着提高患者PFS(HR 0.781;95% CI,0.492-1.240);而在“扩展高危”人群中,定义为具有细胞遗传异常高风险和/或1q21扩增的人群,HR 0.664;(95% CI,0.474–0.928)。

研究表明,对于具有高风险或标准风险细胞遗传的患者,IRd相比Rd均显现出实质性的优势,并可显着提高细胞遗传异常高风险的患者的PFS。

原始出处:

Herve Avet-Loiseau,et al.Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients.Blood.October 20,2017.https://doi.org/10.1182/blood-2017-06-791228

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    2017-10-25 freve

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