Tauseef Abubakar, Zafar Maryam, Silberstein Peter, Nahas Joseph, Frederickson Thomas, Abodunrin Faith, Abbas Anum, Arshad Wafa, Lateef Noman, Rangoonwala Hussain, Albagoush Sara, Mirza Mohsin
Internal Medicine Department, Omaha, Nebraska, USA.
Internal Medicine Department, DUHS, Karachi, Pakistan.
J Family Med Prim Care. 2022 Jun;11(6):2648-2655. doi: 10.4103/jfmpc.jfmpc_1987_21. Epub 2022 Jun 30.
With an increase in number of cases of relapsed or refractory multiple myeloma (RRMM), scientist have discovered various combination of medications among which one is daratumumab, Daratumumab is a mono-clonal antibody which attacks CD-38 markers present in abundance on the surface of myeloma cells and is used universally for the treatment of primary newly diagnosed multiple myeloma patients.
This meta-analysis was conducted according to Cochrane Collaboration guidelines in which initially 679 articles were evaluated for relevance on abstract level followed by full text screening of final list of 45 articles. Out of the 45 articles, only 10 articles qualified for selection criteria for eligibility. Three Phase 3 randomized control clinical trials which includes primary outcomes of progression free span and secondary outcomes including complete response, partial response or very good partial response and adverse effects reported were included in this study.
A total of three studies including 1533 patients (849 in Daratumumab treatment group while 684 patients in control group) were included in the study. All three of these studies were phase 3 clinical trial conducted to observe the role of daratumumab in relapsed and refractory multiple myeloma. Mean age reported was 65 years in both treatment and control groups. This study showed that daratumumab improves primary and secondary outcomes including progression free span, overall response rate, very good partial response, and complete response. However, daratumumab increases drug induced adverse effects.
Our study confirmed that daratumumab in combination therapy improved primary and secondary outcomes when compared with platinum-based chemotherapy, but more adverse effects were reported in the combination group. So, we recommend that combination therapy should include daratumumab in treatment of relapsed and refractory multiple myeloma patients.
随着复发或难治性多发性骨髓瘤(RRMM)病例数量的增加,科学家们发现了多种药物组合,其中一种是达雷妥尤单抗。达雷妥尤单抗是一种单克隆抗体,可攻击骨髓瘤细胞表面大量存在的CD-38标志物,普遍用于治疗初发新诊断的多发性骨髓瘤患者。
本荟萃分析按照Cochrane协作组指南进行,最初对679篇文章进行摘要层面的相关性评估,随后对最终列出的45篇文章进行全文筛选。在这45篇文章中,只有10篇符合入选标准。本研究纳入了三项3期随机对照临床试验,其主要结局为无进展生存期,次要结局包括完全缓解、部分缓解或非常好的部分缓解以及报告的不良反应。
本研究共纳入三项研究,包括1533名患者(达雷妥尤单抗治疗组849例,对照组684例)。所有这三项研究均为3期临床试验,旨在观察达雷妥尤单抗在复发和难治性多发性骨髓瘤中的作用。治疗组和对照组报告的平均年龄均为65岁。本研究表明,达雷妥尤单抗可改善主要和次要结局,包括无进展生存期、总缓解率、非常好的部分缓解和完全缓解。然而,达雷妥尤单抗会增加药物引起的不良反应。
我们的研究证实,与铂类化疗相比,达雷妥尤单抗联合治疗可改善主要和次要结局,但联合治疗组报告的不良反应更多。因此,我们建议在复发和难治性多发性骨髓瘤患者的治疗中,联合治疗应包括达雷妥尤单抗。