Department of Hematology, School of Medicine, Shanghai Fourth People's Hospital, Tongji University, Shanghai, People's Republic of China.
Medical Affairs, Janssen Pharmaceutical Ltd., Beijing, People's Republic of China.
Hematology. 2024 Dec;29(1):2399430. doi: 10.1080/16078454.2024.2399430. Epub 2024 Sep 9.
Renal insufficiency (RI) is a key factor affecting the prognosis of multiple myeloma (MM) patients. Because the benefit of daratumumab for treating MM patients with RI remains unclear, our objective was to evaluate the efficacy of daratumumab on MM patients with RI.
We conducted a systematic search of the PubMed, EMBASE, and Cochrane Library databases as of October 24, 2023. Two independent reviewers screened the article titles, abstracts, and full text to identify the randomized controlled trials (RCTs) meeting the inclusion and exclusion criteria. Meta-analyses were performed using RevMan version 5.4. Outcomes of interest were progression-free survival (PFS), overall survival (OS), complete response or better (≥CR), and minimal residual disease (MRD) negativity, all calculated as hazard ratios (HRs) or risk ratios (RRs) with 95% confidence intervals (CIs).
A total of 10 RCTs with 5003 patients were included. Add-on daratumumab improved PFS and OS among newly diagnosed MM (NDMM) patients with RI (HR 0.48 [95% CI: 0.36, 0.64, I2 = 65%] and HR 0.63 [95% CI: 0.48, 0.82, I2 = 0%]) as well as relapsed/refractory MM (RRMM)-RI patients, compared with the control group (HR 0.46 [95% CI: 0.37, 0.58, I2 = 0%] and HR 0.68 [95% CI: 0.51, 0.92, I2 = 0%]). In terms of the renal status, the efficacy of add-on daratumumab for MMRI patients was similar to that for MM patients with normal renal function. A prolonged PFS benefit for add-on daratumumab treatment versus the control was evident across all RRMM-RI subgroups, and the benefits tended to increase with the follow-up time.
Our results indicate that MM patients with RI could benefit from a daratumumab-added regimen regardless of MM status. Additional high-quality RCTs are still warranted to confirm our findings.
肾功能不全（RI）是影响多发性骨髓瘤（MM）患者预后的关键因素。由于达雷妥尤单抗治疗 RI 多发性骨髓瘤患者的获益尚不清楚，我们的目的是评估达雷妥尤单抗对 RI 多发性骨髓瘤患者的疗效。
我们对 PubMed、EMBASE 和 Cochrane Library 数据库进行了系统检索，截至 2023 年 10 月 24 日。两名独立的审查员筛选了文章标题、摘要和全文，以确定符合纳入和排除标准的随机对照试验（RCT）。使用 RevMan 版本 5.4 进行荟萃分析。感兴趣的结局是无进展生存期（PFS）、总生存期（OS）、完全缓解或更好（≥CR）和微小残留疾病（MRD）阴性，均以风险比（HR）或风险比（RR）和 95%置信区间（CI）表示。
共纳入 10 项 RCT，共 5003 例患者。附加达雷妥尤单抗可改善 RI 初诊 MM（NDMM）患者（HR 0.48 [95% CI：0.36, 0.64，I2=65%] 和 HR 0.63 [95% CI：0.48, 0.82，I2=0%]）和复发/难治性 MM（RRMM）-RI 患者的 PFS 和 OS，与对照组相比（HR 0.46 [95% CI：0.37, 0.58，I2=0%] 和 HR 0.68 [95% CI：0.51, 0.92，I2=0%]）。就肾功能状况而言，附加达雷妥尤单抗治疗 MMRI 患者的疗效与肾功能正常的 MM 患者相似。与对照组相比，附加达雷妥尤单抗治疗的 PFS 获益在所有 RRMM-RI 亚组中均持续存在，且随着随访时间的延长，获益趋势增加。
我们的研究结果表明，无论 MM 状态如何，RI 多发性骨髓瘤患者均可从达雷妥尤单抗联合方案中获益。仍需要更多高质量的 RCT 来证实我们的研究结果。
