Hematology Division, University of Western Ontario, London, ON, Canada.
Hematology Division, London Health Sciences Center, London, ON, Canada.
Eur J Haematol. 2017 Dec;99(6):479-488. doi: 10.1111/ejh.12961. Epub 2017 Oct 6.
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.
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.
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.
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。
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。
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。
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。