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Pomalidomide‐bortezomib‐dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM

机译:复发或难治性多发性骨髓瘤中的Pomalidomide-bortezomib-dexamethasone:OPTIMISMM的日本子集分析

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摘要

In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib and dexamethasone (PVd) significantly improved the progression‐free survival (PFS) and the overall response rate (ORR) vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma. All patients were previously treated with lenalidomide (70% refractory to lenalidomide) and had received one to three prior regimens. Here we report the first efficacy and safety analysis of PVd vs Vd in Japanese patients with relapsed or refractory multiple myeloma. Seventeen patients enrolled in the OPTIMISMM trial in Japan. With a median follow‐up of 14.8 months, the median PFS was 17.6 months with PVd (n = 12) vs 4.4 months with Vd (n = 5), and the ORR was 100% vs 60.0%, respectively. The safety profile was as expected for PVd. Toxicities were managed with dose reductions and interruptions, and no patients discontinued PVd due to treatment‐emergent adverse events. These results are consistent with those in the overall OPTIMISMM patient population and confirm the clinical benefit of PVd in Japanese patients.
机译:在OPTIMISMM 3期试验中,与复发性或难治性多发性骨髓瘤患者相比,泊马利度胺,硼替佐米和地塞米松(PVd)相对于硼替佐米和地塞米松(Vd)显着改善了无进展生存期(PFS)和总体缓解率(ORR)。所有患者先前均接受来那度胺治疗(来那度胺难治性为70%),并已接受一到三个先前的治疗方案。在这里,我们报道了PVd vs Vd在日本复发或难治性多发性骨髓瘤患者中的首次疗效和安全性分析。日本有17名患者参加了OPTIMISMM试验。进行中位随访14.8个月时,PVd(n = 12)的中位PFS为17.6个月,Vd(n = 5)的中位PFS为4.4个月,ORR分别为100%对60.0%。安全性符合PVd的预期。通过减少剂量和中断来控制毒性,并且没有患者因出现治疗不良事件而中断PVd。这些结果与总体OPTIMISMM患者人群的结果一致,并证实了PVd对日本患者的临床益处。

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