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移植后巩固联合来那度胺维持治疗与来那度胺单药维持治疗多发性骨髓瘤的系统评价。

Post-transplant consolidation plus lenalidomide maintenance vs lenalidomide maintenance alone in multiple myeloma: A systematic review.

机构信息

Hematology Division, University of Western Ontario, London, ON, Canada.

Hematology Division, London Health Sciences Center, London, ON, Canada.

出版信息

Eur J Haematol. 2017 Dec;99(6):479-488. doi: 10.1111/ejh.12961. Epub 2017 Oct 6.

Abstract

BACKGROUND

In newly diagnosed multiple myeloma (NDMM), autologous stem cell transplantation (ASCT) remains the standard approach for transplant-eligible patients. To control the inevitable relapse, post-transplant consolidation/maintenance strategies are commonly used. However, the benefit of post-transplant consolidation is still uncertain METHOD: We conducted a systematic review of phase II/III studies to compare the efficacy of post-ASCT consolidation plus lenalidomide maintenance (CON+LEN) vs lenalidomide maintenance alone (LEN alone) in NDMM. A meta-analysis using fixed and random effects models was performed.

RESULTS

Fourteen studies were included with 2275 participants with NDMM treated with ASCT and lenalidomide maintenance. Two groups were identified: CON+LEN group (n = 1102) and LEN alone group (n = 1173). There was no statistically significant difference in the complete response rate between the two groups [RR = 1.1; 95% CI: 0.83-1.44; P = .490]. Interestingly, we found that very good partial response or better rate is around 1.5-fold significantly higher in the CON+LEN group compared to LEN alone group [RR: 1.46; 95% CI: 1.25-1.70; P < .0001]. However, there was no significant difference between the two groups regarding PFS [RR: 1.0; 95% CI: 0.92-1.08, P = .929] and OS [RR: 0.9; 95% CI: 0.92-1.01; P = .148] at 3-4 years follow-up. The risk of secondary primary malignancy (SPM) was also similar between the two groups (RR: 1.2; 95% CI: 0.84-1.92; P = .2). Data on adverse events were limited.

CONCLUSION

Our data suggest that, in NDMM patients treated with upfront ASCT, post-transplant consolidation may improve depth of response, but does not add to OS or PFS, compared to lenalidomide maintenance alone. However, data in this context are still immature.

摘要

背景

在新诊断的多发性骨髓瘤(NDMM)中,自体干细胞移植(ASCT)仍然是适合移植患者的标准方法。为了控制不可避免的复发,通常会使用移植后巩固/维持治疗策略。然而,移植后巩固治疗的益处仍不确定。

方法

我们对 II/III 期研究进行了系统评价,以比较 ASCT 后巩固加来那度胺维持(CON+LEN)与来那度胺单药维持(LEN 单药)在 NDMM 中的疗效。使用固定效应模型和随机效应模型进行了荟萃分析。

结果

共纳入 14 项研究,共有 2275 例接受 ASCT 和来那度胺维持治疗的 NDMM 患者。将患者分为 CON+LEN 组(n=1102)和 LEN 单药组(n=1173)。两组完全缓解率无统计学差异[RR=1.1;95%CI:0.83-1.44;P=0.490]。有趣的是,我们发现 CON+LEN 组非常好的部分缓解或更好的比例明显高于 LEN 单药组,约为 1.5 倍[RR:1.46;95%CI:1.25-1.70;P<0.0001]。然而,两组的无进展生存期[RR:1.0;95%CI:0.92-1.08,P=0.929]和总生存期[RR:0.9;95%CI:0.92-1.01;P=0.148]在 3-4 年随访时无显著差异。两组的继发性原发性恶性肿瘤(SPM)风险也相似[RR:1.2;95%CI:0.84-1.92;P=0.2]。关于不良事件的数据有限。

结论

我们的数据表明,在接受 upfront ASCT 治疗的 NDMM 患者中,与来那度胺单药维持相比,移植后巩固治疗可能会提高缓解深度,但不会增加总生存期或无进展生存期。然而,这方面的数据仍不成熟。

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