National University Cancer Institute, Singapore, Singapore.
Sungkyunkwan University, Samsung Medical Center, Seoul, Korea.
Blood Cancer J. 2019 Oct 8;9(10):83. doi: 10.1038/s41408-019-0245-1.
Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma. However, the data in Asian patients remain limited. We conducted a prospective phase two clinical trial in major cancer centers in Singapore, South Korea, Taiwan, Japan and Hong Kong to assess the efficacy and safety of pomalidomide and dexamethasone combination (PomDex) +/- cyclophosphamide in Asian patients with relapsed/refractory multiple myeloma who failed lenalidomide and bortezomib. Patients were treated with pomalidomide (4 mg daily for 21 days every 4 weeks) and dexamethasone (40 mg weekly). If there is less than a minimal response after three cycles of PomDex, cyclophosphamide 300 mg/m can be added (PomCyDex). A total of 136 patients were enrolled. The median PFS was 9 and 10.8 months for the PomDex and PomCyDex group, respectively. The median OS was 16.3 months. This regimen appears to be active across age groups and prior lines of treatment. This combination was overall well tolerated with grade 3 and 4 adverse events of mainly cytopenias. PomDex is highly active and well-tolerated in Asian patients. The addition of cyclophosphamide can improve the response and outcomes further in patients with suboptimal response to PomDex.
泊马度胺是一种第三代免疫调节药物，与地塞米松联合使用，已被证明对复发/难治性多发性骨髓瘤有效。然而，亚洲患者的数据仍然有限。我们在新加坡、韩国、中国台湾、日本和中国香港的主要癌症中心进行了一项前瞻性的二期临床试验，以评估泊马度胺和地塞米松联合（PomDex）+/-环磷酰胺在接受过来那度胺和硼替佐米治疗后复发/难治性多发性骨髓瘤的亚洲患者中的疗效和安全性。患者接受泊马度胺（4mg，每日一次，每 4 周 21 天）和地塞米松（40mg，每周一次）治疗。如果在接受三周期 PomDex 治疗后反应不佳，可以加用环磷酰胺 300mg/m（PomCyDex）。共纳入 136 例患者。PomDex 和 PomCyDex 组的中位 PFS 分别为 9 个月和 10.8 个月。中位 OS 为 16.3 个月。该方案在各年龄段和既往治疗线中均显示出活性。该联合治疗总体耐受良好，主要为 3 级和 4 级血液学不良事件。泊马度胺在亚洲患者中具有高度活性和良好的耐受性。在对 PomDex 反应不佳的患者中添加环磷酰胺可以进一步提高反应率和改善结局。
