Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
Department of Hematology, 251 General Air-Force Hospital, Athens, Greece.
Am J Hematol. 2019 Apr;94(4):400-407. doi: 10.1002/ajh.25392. Epub 2019 Jan 10.
Optimizing consolidation treatment in transplant-eligible newly diagnosed multiple myeloma patients in order to improve efficacy and bone-related outcomes is intriguing. We conducted an open-label, prospective study evaluating the efficacy and safety of bortezomib and lenalidomide (VR) consolidation after ASCT, in the absence of dexamethasone and bisphosphonates. Fifty-nine patients, who received bortezomib-based induction, were given 4 cycles of VR starting on day 100 post-ASCT. After ASCT, 58% of patients improved their response status, while following VR consolidation 39% further deepened their response; stringent complete response rates increased to 51% after VR from 24% post-ASCT. VR consolidation resulted in a significant reduction of soluble receptor activator of nuclear factor-κB ligand/osteoprotegerin ratio and sclerostin circulating levels, which was more pronounced among patients achieving very good partial response or better. After a median follow-up of 62 months, no skeletal-related events (SREs) were observed, despite the lack of bisphosphonates administration. The median TTP after ASCT was 37 months, while median overall survival (OS) has not been reached yet; the probability of 4- and 5-year OS was 81% and 64%, respectively. In conclusion, VR consolidation is an effective, dexamethasone- and bisphosphonate-free approach, which offers long OS with improvements on bone metabolism and no SREs.
优化适合移植的初诊多发性骨髓瘤患者的巩固治疗,以提高疗效和改善与骨骼相关的结局,这是很有吸引力的。我们进行了一项开放性、前瞻性研究,评估了硼替佐米和来那度胺(VR)巩固治疗在没有地塞米松和双膦酸盐的情况下,在 ASCT 后的疗效和安全性。59 例接受硼替佐米为基础的诱导治疗的患者,在 ASCT 后第 100 天开始接受 4 个周期的 VR。ASCT 后,58%的患者改善了缓解状态,而在接受 VR 巩固治疗后,39%的患者进一步加深了缓解程度;严格的完全缓解率从 ASCT 后的 24%增加到 VR 后的 51%。VR 巩固治疗导致可溶性核因子-κB 配体/骨保护素受体比率和硬化素循环水平显著降低,在达到非常好的部分缓解或更好的患者中更为明显。在中位随访 62 个月后,尽管未使用双膦酸盐,但未观察到骨骼相关事件(SREs)。ASCT 后的中位无进展生存期(TTP)为 37 个月,而中位总生存期(OS)尚未达到;4 年和 5 年 OS 的概率分别为 81%和 64%。总之,VR 巩固治疗是一种有效、无地塞米松和双膦酸盐的方法,可提供长期的 OS,改善骨代谢,且无 SREs。