Gay Francesca, Zamagni Elena, Cole Craig Emmitt, Scheid Christof, Hultcrantz Malin, Chorazy Justyna, Iheanacho Ike, Pandey Anuja, Bitetti Jacopo, Boytsov Natalie, Purser Molly, McNamara Simon, Iida Shinsuke
University Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
Department of Biotechnology and Health Science, University of Torino, Torino, Italy.
Front Oncol. 2025 Mar 12;15:1550644. doi: 10.3389/fonc.2025.1550644. eCollection 2025.
Anti-CD38-based therapy has become a backbone regimen for the treatment of multiple myeloma (MM), approved in first-, second-, and third-line settings. The effectiveness of anti-CD38-based retreatment after an initial relapse on previous anti-CD38-based therapy is unclear. Here we present the results of a systematic literature review investigating the clinical outcomes of anti-CD38-based retreatment in patients with relapsed/refractory MM.
Medline/Embase, congress publications, and other sources were searched (to December 8, 2023) for relevant articles in English and screened for eligibility criteria using the Population, Intervention, Comparator, Outcomes, Study Design (PICOS) framework, and data were then extracted for outcomes including progression-free survival (PFS), overall survival (OS), and overall response rate (ORR).
In total, 2938 records were identified from the initial Medline/Embase search and 11 were identified from other sources; 34 were eligible for inclusion, representing 24 studies (6 clinical [n=18-307] and 18 real-world evidence [RWE; n=19-583]). Where reported, median follow-up ranged from 1.9-43.0 months across 6 clinical and 8.7-53.0 months across 10 RWE studies. For clinical trials, anti-CD38-based retreatment resulted in a median PFS of 1.0-2.8 months in all but one trial (19.4 months), a median OS of 10.7-19.1 months (not reached in one trial), and ORRs of 0-75%. RWE studies reported a median PFS of 1.5-8.4 months, a median OS of 8.4-19.0 months (not reached in one study), and ORRs of 24.6-90.0%.
Findings from this systematic literature review indicate that clinical outcomes with anti-CD38-based retreatment are variable and offer limited clinical benefit in patients with relapsed/refractory MM, including in those refractory to anti-CD38-based treatment.
基于抗CD38的疗法已成为治疗多发性骨髓瘤(MM)的主要方案,在一线、二线和三线治疗中均获批准。先前接受基于抗CD38的治疗初次复发后,再次使用基于抗CD38的疗法进行治疗的有效性尚不清楚。在此,我们展示了一项系统文献综述的结果,该综述调查了复发/难治性MM患者接受基于抗CD38的再治疗后的临床结局。
检索了Medline/Embase、会议出版物及其他来源(截至2023年12月8日)的英文相关文章,并使用人群、干预措施、对照、结局、研究设计(PICOS)框架筛选纳入标准,然后提取包括无进展生存期(PFS)、总生存期(OS)和总缓解率(ORR)在内的结局数据。
通过对Medline/Embase的初始检索共识别出2938条记录,从其他来源识别出11条;34条符合纳入标准,代表24项研究(6项临床研究[n = 18 - 307]和18项真实世界证据[RWE;n = 19 - 583])。如报告所述,6项临床研究的中位随访时间为1.9 - 43.0个月,10项RWE研究的中位随访时间为8.7 - 53.0个月。对于临床试验,除一项试验(19.4个月)外,基于抗CD38的再治疗导致中位PFS为1.0 - 2.8个月,中位OS为10.7 - 19.1个月(一项试验未达到),ORR为0 - 75%。RWE研究报告的中位PFS为1.5 - 8.4个月,中位OS为8.4 - 19.0个月(一项研究未达到),ORR为24.6 - 90.0%。
这项系统文献综述的结果表明,基于抗CD38的再治疗的临床结局存在差异,并且对复发/难治性MM患者,包括对基于抗CD38治疗难治的患者,临床获益有限。