Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum
Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum
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DOI：
10.1007/s12185-018-2416-4
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发表时间：
2018-05-01
影响因子：
2.1
通讯作者：
Takaori-Kondo, Akifumi
中科院分区：
文献类型：
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作者：
Matsumura-Kimoto, Yayoi;Kuroda, Junya;Takaori-Kondo, Akifumi
在日本的真实世界临床实践环境中，回顾性研究了泊马度胺（POM）单药治疗或POM加地塞米松（DEX）（POM/DEX）治疗复发性和难治性多发性骨髓瘤（RRMM）的疗效和安全性的决定因素。受试者是在关西骨髓瘤论坛注册的108名患者，他们接受POM或POM/DEX治疗。其中，分别有79例（73%）、73例（68%）和58例（54%）对硼替佐米（BTZ）、来那度胺（LEN）以及BTZ和LEN均耐药。未达到中位总生存期（OS）。中位至治疗失败时间（TTF）为4.4个月。在96例患者中记录了最佳缓解，总缓解率（ORR）为31%，至少达到疾病稳定的比率为79%。POM前治疗方案数量>= 5、非IgG型M蛋白、从初始治疗到POM或POM/DEX治疗的时间< 2年与较短的TTF和OS相关。常见的（> 10%）严重不良事件包括中性粒细胞减少55.1%，血小板减少33.7%，贫血30.6%，中性粒细胞减少12.2%，乏力11.2%，厌食10.2%。总之，POM和POM/DEX显示出对RRMM的实质性疗效，但需要POM的新联合治疗以进一步提高疗效而不引起血液学毒性。
Determinants of the efficacy and safety of pomalidomide (POM) monotherapy or POM plus dexamethasone (DEX) (POM/DEX) for relapsed and refractory multiple myeloma (RRMM) were examined retrospectively in a real-world clinical practice setting in Japan. The subjects were 108 patients registered with the Kansai Myeloma Forum, who were treated with either POM or POM/DEX. Of these, 79 (73%), 73 (68%), and 58 (54%) were resistant to bortezomib (BTZ), lenalidomide (LEN), and both BTZ and LEN, respectively. The median overall survival (OS) was not reached. The median time to treatment failure (TTF) was 4.4 months. The best response was recorded in 96 patients, with a 31% overall response rate (ORR) and a 79% rate of achieving at least stable disease. Number of pre-POM regimens >= 5, non-IgG-type M-protein, and time from initial therapy to POM or POM/DEX therapy < 2 years were associated with shorter TTF and OS. Frequent (> 10%) severe adverse events included neutropenia (55.1%), thrombocytopenia (33.7%), anemia (30.6%), febrile neutropenia (12.2%), fatigue (11.2%), and anorexia (10.2%). In conclusion, POM and POM/DEX showed substantial efficacy against RRMM, but new combination therapies with POM are needed to improve efficacy further without causing hematologic toxicities.