Avivi Irit, Yekutiel Naama, Shragai Tamir, Cohen Yael C, Grunspan Moshe, Rivlin Noa, Frankel Neta, Cohen Raanan, Weil Clara, Chodick Gabriel
Department of Hematology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Ann Hematol. 2023 Nov;102(11):3075-3081. doi: 10.1007/s00277-023-05307-1. Epub 2023 Aug 30.
Treatment options for multiple myeloma (MM) at 1st relapse are expanding. The current study compared common 2nd line regimens administered in a real-world setting. MM patients registered in Maccabi health care services and treated with second line therapy during 2014-2020 were evaluated, analyzing factors affecting time to third line therapy (TT3T). The study included 500 MM patients, previously treated with proteasome inhibitor (PI)-based induction. Median age at second line treatment was 68.5 years (IQR: 61.6-76.4). Most patients received a triplet based induction composed of PI (n = 471, 94.2%), with (n = 71) or without IMID (n = 400), followed by second line treatment composed of lenalidomide-dexamethasone (RD) (n = 225, 45%) or lenalidomide-dexamethasone-daratumumab (RD-Dara (n = 104, 20.8%)). Multivariable analysis confirmed treatment type (RD-Dara vs. IMID) to be associated with a lower risk to progress to third line therapy; (HR = 0.5, 95% CI 0.3-0.86, p = 0.012). Within a median follow-up period of 22.5 months (intraquartile range 11.1-39.4 m), median TT3T was not reached in patients receiving RD-Dara vs. 32.4 months (95% CI 18.0-46.8 m) with IMID, 18 months (95% CI 10.4-25.6 m) with IMID-PI and 12.1 months (95% CI 5.6-18.7 m) with PI-based regimen. In contrast, PI vs. IMID-based therapy and increased body weight were associated with a higher likelihood of progression (HR = 2.56 (95% CI 1.49-4.42); HR = 1.43, (95% CI 0.96-2.14), p = 0.08). To conclude, second line therapy with RD-Dara was associated with a significantly longer TT3T compared with IMID-based regimen, longer than obtained with PI-IMID and PI-based regimens, in patients treated outside clinical studies and previously exposed to bortezomib.
多发性骨髓瘤（MM）首次复发时的治疗选择正在不断增加。本研究比较了在真实世界中应用的常见二线治疗方案。对在麦卡比医疗保健服务机构注册并于2014年至2020年期间接受二线治疗的MM患者进行评估，分析影响至三线治疗时间（TT3T）的因素。该研究纳入了500例此前接受过基于蛋白酶体抑制剂（PI）诱导治疗的MM患者。二线治疗时的中位年龄为68.5岁（四分位间距：61.6 - 76.4岁）。大多数患者接受了由PI组成的三联诱导治疗（n = 471，94.2%），联合（n = 71）或不联合免疫调节药物（IMID）（n = 400），随后接受来那度胺 - 地塞米松（RD）（n = 225，45%）或来那度胺 - 地塞米松 - 达雷妥尤单抗（RD - Dara，n = 104，20.8%）组成的二线治疗。多变量分析证实治疗类型（RD - Dara与IMID）与进展至三线治疗的较低风险相关；（风险比[HR] = 0.5，95%置信区间[CI] 0.3 - 0.86，p = 0.012）。在中位随访期22.5个月（四分位间距11.1 - 39.4个月）内，接受RD - Dara治疗的患者未达到中位TT3T，而接受IMID治疗的患者为32.4个月（95% CI 18.0 - 46.8个月），接受IMID - PI治疗的患者为18个月（95% CI 10.4 - 25.6个月），接受基于PI方案治疗的患者为12.1个月（95% CI 5.6 - 18.7个月）。相比之下，基于PI与基于IMID的治疗以及体重增加与更高的进展可能性相关（HR = 2.56（95% CI 1.49 - 4.42）；HR = 1.43，（9�% CI 0.96 - 2.14），p = 0.08）。总之，在临床研究之外接受治疗且既往接触过硼替佐米的患者中，与基于IMID的方案相比，采用RD - Dara进行二线治疗与显著更长的TT3T相关，且长于采用PI - IMID和基于PI方案所获得的时间。
