Biothecnology Research Unit, AO of Cosenza, Cosenza, Italy.
Hematology and Bone Marrow Transplant Unit, Hemato-Oncology Department, Augusta Victoria Hospital, East Jerusalem, Israel.
Eur J Haematol. 2022 Mar;108(3):178-189. doi: 10.1111/ejh.13723. Epub 2021 Nov 9.
The lack of a randomized trial comparing carfilzomib (K) versus elotuzumab (Elo) associated with lenalidomide and dexamethasone (Rd) prompted us to assess the relative usefulness of one triplet over the other. Five independent retrospective cohorts of 883 relapsed/refractory multiple myeloma (RRMM) patients, including 300 EloRd and 583 KRd cases, outside clinical trials, entered this non-randomized comparison. KRd cohort accounted for a higher incidence of younger patients, cases with ≥3 lines of therapy, already exposed to lenalidomide, International Staging System (ISS) stage III, and abnormal lactic dehydrogenase (LDH) level compared with EloRd cohort. Moreover, cytogenetic risk categories, detected in roughly one-third of cases, were equally distributed between the two therapy arms. The probability of CR+VGPR response was significantly higher in KRd (n = 314, 53.9%) than in EloRd patients (n = 111, 37.0%). Likewise, the cumulative incidence function of CR+VGPR, taking into account the competitive risk of death, was significantly higher in KRd arm patients than those in the EloRd arm (p = .003). Moreover, KRd treatment significantly reduced the progression or death risk by 46% in an adjusted multivariate analysis (HR: 0.54, 95% CI 0.42-0.69, p < .0001). Finally, in an adjusted illness-progression/death model, the effect of KRd versus EloRd was of higher magnitude among those who achieved CR+VGPR (-39% hazard ratio reduction, p = .02) than among those who achieved < VGPR (-29% hazard ratio reduction, p = .007). With limitations characteristic to any retrospective analysis, this current clinical practice study's overall results demonstrated potential benefits of KRd therapy compared with EloRd. This observation may help the daily clinical practice.
由于缺乏比较卡非佐米(K)与埃罗妥珠单抗(Elo)联合来那度胺和地塞米松(Rd)与 KRd 方案的随机临床试验,我们评估了这两种三联方案的相对有效性。这项非随机比较纳入了 5 个独立的、来自临床试验之外的 883 例复发/难治性多发性骨髓瘤(RRMM)患者回顾性队列,包括 300 例 EloRd 和 583 例 KRd 病例。KRd 队列中年轻患者、已接受过来那度胺治疗、三线或以上治疗、国际分期系统(ISS)Ⅲ期和乳酸脱氢酶(LDH)水平异常的病例比例高于 EloRd 队列。此外,细胞遗传学危险分层约三分之一的病例在两种治疗方案中分布均匀。KRd(n=314,53.9%)的完全缓解(CR)+非常好的部分缓解(VGPR)应答率显著高于 EloRd(n=111,37.0%)。同样,考虑到死亡的竞争风险,KRd 组患者的 CR+VGPR 累积发生率函数显著高于 EloRd 组(p=0.003)。此外,多变量调整分析显示,KRd 治疗可显著降低 46%的进展或死亡风险(HR:0.54,95%CI 0.42-0.69,p<0.0001)。最后,在调整后的疾病进展/死亡模型中,KRd 与 EloRd 的疗效差异在达到 CR+VGPR 的患者中更为显著(风险比降低 39%,p=0.02),而在未达到 VGPR 的患者中降低 29%(风险比降低 29%,p=0.007)。由于存在任何回顾性分析的固有局限性,这项临床实践研究的总体结果表明 KRd 治疗与 EloRd 相比具有潜在优势。这一观察结果可能有助于日常临床实践。