Terpos Evangelos, Repousis Panagiotis, Lalayanni Chrysavgi, Hatjiharissi Evdoxia, Assimakopoulou Theodora, Vassilopoulos Georgios, Pouli Anastasia, Spanoudakis Emmanouil, Michalis Eurydiki, Pangalis Gerassimos, Ntanasis-Stathopoulos Ioannis, Poziopoulos Christos, Kyrtsonis Marie-Christine, Pappa Vasiliki, Symeonidis Argiris, Georgopoulos Christos, Zikos Panagiotis M, Gavriatopoulou Maria, Papadaki Helen A, Dadakaridou Magdalini, Karvounis-Marolachakis Kiki, Katodritou Eirini
Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra General Hospital, 11527 Athens, Greece.
Department of Hematology, "METAXA" Cancer Hospital of Piraeus, 18537 Athens, Greece.
J Clin Med. 2021 Apr 5;10(7):1509. doi: 10.3390/jcm10071509.
The "POWERFUL" multicenter, retrospective, and prospective study investigated the effectiveness of pomalidomide plus low-dose dexamethasone (POM/LoDex) therapy in relapsed/refractory multiple myeloma in routine care in Greece. Ninety-nine eligible adult patients treated with POM/LoDex according to the approved label after having received ≥2 prior therapies, including lenalidomide and bortezomib, were consecutively enrolled between 16 November 2017 and 21 February 2019 in 18 hematology departments. Fifty patients (50.5%) started POM/LoDex as third-line treatment. During the treatment period (median: 8.3 months; range: 0.3-47.6 months), the median POM dose was 4 mg/day, and 31.3% of the patients received additional antimyeloma agents. The overall response rate was 32.3%. During a median follow-up period of 13.8 months (Kaplan-Meier estimate), the median progression-free survival (PFS) was 10.5 months (95% CI: 7.4-14.4). The PFS was not significantly different between patients receiving POM/LoDex in the third versus later line of therapy, nor between patients receiving concomitant antimyeloma therapy versus POM/LoDEx doublet. During the prospective safety data collection period (median: 7.6 months) among patients with prospective follow-up (N = 75), POM-related adverse event incidence rate was 42.7% (serious: 18.7%; grade ≥ 3 hematological POM-related adverse events: 8.0%). Only neutropenia (13.3%) was reported at a frequency ≥10%. In conclusion, in this real-world study, POM/LoDex displayed a long PFS with no new safety signals emerging.
“强效”多中心回顾性和前瞻性研究调查了泊马度胺联合低剂量地塞米松（POM/LoDex）疗法在希腊常规治疗复发/难治性多发性骨髓瘤中的有效性。2017年11月16日至2019年2月21日期间，18个血液科连续纳入了99例符合条件的成年患者，这些患者在接受了包括来那度胺和硼替佐米在内的≥2种先前治疗后，根据批准的标签接受POM/LoDex治疗。50例患者（50.5%）开始将POM/LoDex作为三线治疗。在治疗期间（中位数：8.3个月；范围：0.3 - 47.6个月），泊马度胺的中位剂量为4毫克/天，31.3%的患者接受了额外的抗骨髓瘤药物治疗。总缓解率为32.3%。在中位随访期13.8个月（Kaplan-Meier估计）时，中位无进展生存期（PFS）为10.5个月（95%置信区间：7.4 - 14.4）。接受POM/LoDex作为三线治疗与更后线治疗的患者之间，以及接受联合抗骨髓瘤治疗与POM/LoDex双联治疗的患者之间，PFS无显著差异。在有前瞻性随访的患者（N = 75）的前瞻性安全性数据收集期（中位数：7.6个月）内，与泊马度胺相关的不良事件发生率为42.7%（严重：18.7%；≥3级血液学与泊马度胺相关的不良事件：8.0%）。仅中性粒细胞减少症（13.3%）的报告频率≥10%。总之，在这项真实世界研究中，POM/LoDex显示出较长的PFS，且未出现新的安全信号。
