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硼替佐米一线巩固治疗多发性骨髓瘤自体移植后完全缓解患者与观察对比以实现完全缓解(TUBA研究)

Targeting complete response with upfront bortezomib consolidation versus observation after the achievement of complete response following autologous transplantation for multiple myeloma (TUBA study).

作者信息

Nakasone Hideki, Terasako-Saito Kiriko, Hirano Teiichi, Wake Atsushi, Shimizu Seiichi, Kurita Naoki, Yamazaki Etsuko, Usuki Kensuke, Akazawa Kohei, Kanda Junya, Minauchi Koichiro, Yamamoto Go, Tanimoto Shiori, Kamoshita Masaharu, Yokoyama Yasuhisa, Miyaoka Etsuo, Ota Shuichi, Kako Shinichi, Izutsu Koji, Kanda Yoshinobu

机构信息

Division of Hematology, Saitama Medical Center, Jichi Medical University, Saitama, Japan.

Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.

出版信息

Hematol Oncol. 2018 Feb;36(1):202-209. doi: 10.1002/hon.2452. Epub 2017 Jul 6.

Abstract

Complete response (CR) after treatment for multiple myeloma is associated with superior progression-free survival (PFS). Multiple myeloma patients were prospectively recruited for induction treatment with bortezomib and dexamethasone (BD) followed by autologous hematopoietic cell transplantation (auto-HCT) between 2010 and 2012. If patients did not achieve CR after auto-HCT, BD consolidation therapy was added to target CR. After the BD induction phase (n = 46), greater than or equal to CR was achieved in 4 patients (8%). After auto-HCT (n = 34), greater than or equal to CR was achieved in 9 patients (20%) and very good partial response (VGPR) was achieved in 11 (24%). Of the 24 patients who received auto-HCT and whose response was less than CR, 21 received BD consolidation therapy for a median of 4 courses. Finally, the maximum response with or without BD consolidation was greater than or equal to CR in 19 (41%), VGPR in 7 (15%), and PR in 6 (13%). Through BD consolidation, CR was achieved in 8 of 11 patients with post-HCT VGPR and in 2 of 12 patients with post-HCT PR. In total, 4 year PFS and overall survival were 43 and 80%, respectively. After adjusting for clinical factors, there was no difference in PFS between CR patients after auto-HCT and BD consolidation, while patients with less than or equal to VGPR after consolidation had a significantly lower PFS. Patients with post-HCT CR showed good PFS, and targeting CR through BD consolidation could improve the CR rate. It would be worthwhile to prospectively compare the efficacy of consolidation only for patients who failed to achieve CR to a universal consolidation strategy.

摘要

多发性骨髓瘤治疗后的完全缓解(CR)与无进展生存期(PFS)延长相关。2010年至2012年期间,前瞻性招募了多发性骨髓瘤患者接受硼替佐米和地塞米松(BD)诱导治疗,随后进行自体造血细胞移植(auto-HCT)。如果患者在auto-HCT后未达到CR,则加用BD巩固治疗以实现CR。在BD诱导期(n = 46)后,4例患者(8%)达到大于或等于CR。在auto-HCT后(n = 34),9例患者(20%)达到大于或等于CR,11例(24%)达到非常好的部分缓解(VGPR)。在24例接受auto-HCT且缓解低于CR的患者中,21例接受了BD巩固治疗,中位疗程为4个疗程。最后,无论是否进行BD巩固治疗,最大缓解率为大于或等于CR的有19例(41%),VGPR的有7例(15%),部分缓解(PR)的有6例(13%)。通过BD巩固治疗,11例HCT后VGPR患者中有8例达到CR,12例HCT后PR患者中有2例达到CR。总体而言,4年PFS和总生存率分别为43%和80%。在调整临床因素后,auto-HCT和BD巩固治疗后的CR患者之间的PFS没有差异,而巩固治疗后小于或等于VGPR的患者PFS显著更低。HCT后CR的患者显示出良好的PFS,通过BD巩固治疗实现CR可提高CR率。前瞻性比较仅对未达到CR的患者进行巩固治疗与通用巩固策略的疗效是值得的。

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