Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.
Department of Hematology, Kameda Medical Center, Chiba, Japan.
Cancer Sci. 2020 Jun;111(6):2116-2122. doi: 10.1111/cas.14415. Epub 2020 May 13.
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.
在 3 期 OPTIMISMM 试验中，与硼替佐米和地塞米松（Vd）相比，泊马度胺、硼替佐米和地塞米松（PVd）显著改善了复发或难治性多发性骨髓瘤患者的无进展生存期（PFS）和总缓解率（ORR）。所有患者之前均接受过来那度胺（70%对来那度胺耐药）治疗，且已接受过 1 至 3 种先前的治疗方案。在此，我们报告了 PVd 与 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。17 名患者在日本参加了 OPTIMISMM 试验。中位随访 14.8 个月时，PVd（n=12）的中位 PFS 为 17.6 个月，Vd（n=5）为 4.4 个月，ORR 分别为 100%和 60.0%。安全性特征与 PVd 一致。通过减少剂量和中断治疗来管理毒性，没有患者因治疗出现的不良反应而停止使用 PVd。这些结果与总体 OPTIMISMM 患者人群一致，证实了 PVd 在日本患者中的临床获益。
