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硼替佐米诱导、减低强度移植和来那度胺巩固-维持治疗多发性骨髓瘤:更新结果。

Bortezomib induction, reduced-intensity transplantation, and lenalidomide consolidation-maintenance for myeloma: updated results.

机构信息

Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy.

出版信息

Blood. 2013 Aug 22;122(8):1376-83. doi: 10.1182/blood-2013-02-483073. Epub 2013 Jun 17.

Abstract

A sequential approach including bortezomib induction, intermediate-dose melphalan, and autologous stem cell transplantation (ASCT), followed by lenalidomide consolidation-maintenance, has been evaluated. Efficacy and safety data have been analyzed on intention-to-treat and results updated. Newly diagnosed myeloma patients 65 to 75 years of age (n = 102) received 4 cycles of bortezomib-pegylated liposomal doxorubicin-dexamethasone, tandem melphalan (100 mg/m(2)) followed by ASCT (MEL100-ASCT), 4 cycles of lenalidomide-prednisone consolidation (LP), and lenalidomide maintenance (L) until disease progression. The complete response (CR) rate was 33% after MEL100-ASCT, 48% after LP and 53% after L maintenance. After a median follow-up of 66 months, median time-to-progression (TTP) was 55 months and median progression-free survival 48 months. Median overall survival (OS) was not reached, 5-year OS was 63%. In CR patients, median TTP was 70 months and 5-year OS was 83%. Median survival from relapse was 28 months. Death related to adverse events (AEs) occurred in 8/102 patients during induction or transplantation. Rate of death related to AEs was higher in patients ≥70 years compared with younger (5/26 vs 3/76, P = .024). Bortezomib-induction followed by ASCT and lenalidomide consolidation-maintenance is a valuable option for elderly myeloma patients, with the greatest benefit in those younger than 70 years of age.

摘要

已经评估了包括硼替佐米诱导、中剂量美法仑和自体干细胞移植(ASCT),然后进行来那度胺巩固维持的序贯治疗。对意向治疗和结果更新进行了疗效和安全性数据分析。65 至 75 岁的新诊断骨髓瘤患者(n=102)接受 4 个周期的硼替佐米-聚乙二醇脂质体阿霉素-地塞米松、串联美法仑(100mg/m²),然后进行 ASCT(MEL100-ASCT),4 个周期的来那度胺-泼尼松巩固(LP)和来那度胺维持(L),直到疾病进展。MEL100-ASCT 后完全缓解(CR)率为 33%,LP 后为 48%,L 维持后为 53%。中位随访 66 个月后,中位无进展生存期(TTP)为 55 个月,中位无进展生存期为 48 个月。中位总生存期(OS)未达到,5 年 OS 为 63%。在 CR 患者中,中位 TTP 为 70 个月,5 年 OS 为 83%。中位复发后生存期为 28 个月。诱导或移植期间,102 例患者中有 8 例(8/102)发生与不良事件(AE)相关的死亡。与 AE 相关的死亡率在 70 岁以上患者中高于年轻患者(5/26 与 3/76,P=0.024)。硼替佐米诱导后进行 ASCT 和来那度胺巩固维持是老年骨髓瘤患者的一种有价值的选择,在年龄小于 70 岁的患者中获益最大。

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