Division of Hematology, Mayo Clinic, Rochester, MN, USA.
Leukemia. 2018 Mar;32(3):712-718. doi: 10.1038/leu.2017.256. Epub 2017 Aug 14.
Post-transplant maintenance is widely used in multiple myeloma (MM); however, there is a lack of data on real-world outcomes. We have analyzed 577 patients with newly diagnosed MM undergoing early auto-transplantation between 2010 and 2015. A total of 341, 132 and 104 patients received no, lenalidomide (Len) or bortezomib (Bort) maintenance, respectively. Patients receiving Len or Bort maintenance had a higher incidence of high-risk cytogenetics by fluorescence in situ hybridization (31% (Len) vs 58% (Bort) vs 8% (No); P<0.001). Len maintenance led to a superior progression-free survival (PFS) compared with no maintenance (median, 37 vs 28 months, respectively; P=0.002; adjusted hazard ratio 0.48 (95% CI, 0.35-0.66)), including in subgroups with ISS stage III disease (median, 40 vs 24 months; P=0.008) and high-risk cytogenetics (median, 27 vs 16 months; P=0.032). Bort maintenance did not confer PFS benefit for the entire cohort, but improved PFS in the high-risk cytogenetic subgroup (median, 28 vs 16 months; P=0.035). Discontinuation due to toxicity was seen in 17 and 7% of patients receiving Len or Bort maintenance, respectively. Our results indicate that post-transplant maintenance with Len or Bort is well tolerated in clinical practice and improves PFS in high-risk subgroups of MM patients.
移植后维持治疗广泛应用于多发性骨髓瘤(MM);然而,目前缺乏真实世界疗效的数据。我们分析了 2010 年至 2015 年期间 577 例接受早期自体移植的新诊断 MM 患者。共有 341、132 和 104 例患者分别未接受来那度胺(Len)、硼替佐米(Bort)维持治疗。接受 Len 或 Bort 维持治疗的患者,通过荧光原位杂交(FISH)检测到的高危细胞遗传学的发生率更高(31%(Len)vs.58%(Bort)vs.8%(No);P<0.001)。与未接受维持治疗的患者相比,接受 Len 维持治疗的患者无进展生存期(PFS)更优(中位 PFS 分别为 37 个月和 28 个月,P=0.002;调整后的危险比为 0.48(95%CI,0.35-0.66)),包括 ISS 分期为 III 期疾病(中位 PFS 分别为 40 个月和 24 个月,P=0.008)和高危细胞遗传学患者(中位 PFS 分别为 27 个月和 16 个月,P=0.032)。对于整个队列,Bort 维持治疗并未带来 PFS 获益,但改善了高危细胞遗传学亚组的 PFS(中位 PFS 分别为 28 个月和 16 个月,P=0.035)。接受 Len 或 Bort 维持治疗的患者中,分别有 17%和 7%因毒性而停药。我们的研究结果表明,在临床实践中,Len 或 Bort 移植后维持治疗耐受性良好,并能改善高危 MM 患者亚组的 PFS。