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基于伊沙佐米治疗多发性骨髓瘤的疗效和安全性的真实世界数据:一项中国单中心研究

Real-world Data on the Efficacy and Safety of Ixazomib-based Therapy in Multiple Myeloma: A Single-center Study in China.

作者信息

Ding Kai, Yu Hong, Shao Yuan-Yuan, Li Li-Yan, Wang Chao-Meng, Song Jia, Li Li-Juan, Fu Rong

机构信息

Department of Hematology, Tianjin Medical University General Hospital, Tianjin 300052, People's Republic of China.

出版信息

Cancer Manag Res. 2020 Sep 23;12:8935-8941. doi: 10.2147/CMAR.S261887. eCollection 2020.

Abstract

OBJECTIVE

To assess the short-term efficacy and safety of ixazomib in Chinese multiple myeloma (MM) patients in the real world.

METHODS

Fifty-nine MM patients who received at least one cycle of ixazomib-based therapy between 1 June 2018 and 30 September 2019 were retrospectively analyzed in Tianjin Medical University General Hospital. Thirteen newly diagnosed MM (NDMM), 13 refractory/relapsed MM (RRMM) and 33 continuous therapy (27 bortezomib peripheral neuritis (PN) intolerant and six maintenance therapy) MM patients were included. The indicated overall response rate (ORR), time to overall response (TOR), and adverse events (AEs) were investigated.

RESULTS

The ORR in NDMM was 76.9%, with one complete response (CR), five very good partial response (VGPR), four partial response (PR), median PFS, and TOR were 122 (66-272) days and 49 (22-108) days. The ORR in RRMM was 46.2%, with one CR, two VGPR, three PR, median PFS, and TOR were 79 (28-169) days and 59 (23-88) days. The ORR in continuous therapy MM patients was 100%, with nine stringent CR, 15 CR, six VGPR and three PR, median TOR was 75 (25-141) days. There were no significant differences regarding ORR between patients with cytogenetic high risk and standard risk in three subgroups (all >0.05). The most frequent hematological AEs were anemia (13.6%) and thrombocytopenia (10.2%). The most common nonhematological AEs were PN (25.0%) and diarrhea (13.6%).

CONCLUSION

The real-world data demonstrated that ixazomib-based therapy was generally effective and safe in the short term for MM patients.

摘要

目的

评估在真实世界中,伊沙佐米对中国多发性骨髓瘤(MM)患者的短期疗效和安全性。

方法

对2018年6月1日至2019年9月30日期间在天津医科大学总医院接受至少一个周期基于伊沙佐米治疗的59例MM患者进行回顾性分析。纳入13例新诊断MM(NDMM)患者、13例难治/复发MM(RRMM)患者和33例持续治疗(27例对硼替佐米外周神经炎(PN)不耐受和6例维持治疗)MM患者。研究了指定的总缓解率(ORR)、总缓解时间(TOR)和不良事件(AE)。

结果

NDMM患者的ORR为76.9%,其中1例完全缓解(CR)、5例非常好的部分缓解(VGPR)、4例部分缓解(PR),中位无进展生存期(PFS)和TOR分别为122(66 - 272)天和49(22 - 108)天。RRMM患者的ORR为46.2%,其中1例CR、2例VGPR、3例PR,中位PFS和TOR分别为79(28 - 169)天和59(23 - 88)天。持续治疗MM患者的ORR为100%,其中9例严格CR、15例CR、6例VGPR和3例PR,中位TOR为75(25 - 141)天。三个亚组中细胞遗传学高危和标准风险患者之间的ORR无显著差异(均>0.05)。最常见的血液学AE是贫血(13.6%)和血小板减少(10.2%)。最常见的非血液学AE是PN(25.0%)和腹泻(13.6%)。

结论

真实世界数据表明,基于伊沙佐米的治疗对MM患者短期而言总体有效且安全。

相似文献

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Clinical study on ixazomib in the treatment of multiple myeloma.伊沙佐米治疗多发性骨髓瘤的临床研究
Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2020 Mar 28;45(3):322-327. doi: 10.11817/j.issn.1672-7347.2020.200060.

本文引用的文献

10
Multiple myeloma.多发性骨髓瘤。
Nat Rev Dis Primers. 2017 Jul 20;3:17046. doi: 10.1038/nrdp.2017.46.

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