Han Xiaoyan, Jiang Xincheng, He Jingsong, Zheng Gaofeng, Xiong Yaqin, Wen Yanling, Yang Yang, He Donghua, Chen Qingxiao, Zhao Yi, Li Yi, Wu Wenjun, Cai Zhen
Department of Hematology and Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Institute of Hematology, Zhejiang University, Hangzhou, Zhejiang, China.
Cancer Med. 2024 May;13(9):e7232. doi: 10.1002/cam4.7232.
Comparative investigations evaluating the efficacy of pomalidomide-based (Pom-based) versus daratumumab-based (Dara-based) therapies in patients with relapsed/refractory multiple myeloma (RRMM) remain scarce, both in randomized controlled trials and real-world studies.
This retrospective cohort study included 140 RRMM patients treated with Pom-based or Dara-based or a combination of pomalidomide and daratumumab (DPd) regimens in a Chinese tertiary hospital between December 2018 and July 2023.
The overall response rates (ORR) for Pom-based (n = 48), Dara-based (n = 68), and DPd (n = 24) groups were 57.8%, 84.6%, and 75.0%, respectively (p = 0.007). At data cutoff on August 1, 2023, the median progression-free survival (PFS) was 5.7 months (95% CI: 5.0-6.5) for the Pom-based group, 10.5 months (5.2-15.8) for the Dara-based group, and 6.7 months (4.0-9.3) for the DPd group (p = 0.056). Multivariate analysis identified treatment regimens (Dara-based vs. Pom-based, DPd vs. Pom-based) and Eastern Cooperative Oncology Group performance status (ECOG PS) as independent prognostic factors for PFS. In the subgroups of patients aged >65 years, with ECOG PS ≥2, lines of therapy ≥2, extramedullary disease or double-refractory disease (refractory to both lenalidomide and proteasome inhibitors), the superiority of Dara-based regimens over Pom-based regimens was not evident. A higher incidence of infections was observed in patients receiving Dara-based and DPd regimens (Pom-based 39.6% vs. Dara-based 64.7% vs. DPd 70.8%, p = 0.009).
In real-world settings, Pom-based, Dara-based, and DPd therapies exhibited favorable efficacy in patients with RRMM. Dara-based therapy yielded superior clinical response and PFS compared to Pom-based therapy.
在复发/难治性多发性骨髓瘤（RRMM）患者中，评估泊马度胺方案（Pom方案）与达雷妥尤单抗方案（Dara方案）疗效的比较研究仍然较少，无论是在随机对照试验还是真实世界研究中。
这项回顾性队列研究纳入了2018年12月至2023年7月在中国一家三级医院接受Pom方案、Dara方案或泊马度胺与达雷妥尤单抗联合方案（DPd方案）治疗的140例RRMM患者。
Pom方案组（n = 48）、Dara方案组（n = 68）和DPd方案组（n = 24）的总缓解率（ORR）分别为57.8%、84.6%和75.0%（p = 0.007）。在2023年8月1日数据截止时，Pom方案组的中位无进展生存期（PFS）为5.7个月（95%CI：5.0 - 6.5），Dara方案组为10.5个月（5.2 - 15.8），DPd方案组为6.7个月（4.0 - 9.3）（p = 0.056）。多因素分析确定治疗方案（Dara方案与Pom方案、DPd方案与Pom方案）和东部肿瘤协作组体能状态（ECOG PS）为PFS的独立预后因素。在年龄>65岁、ECOG PS≥2、治疗线数≥2、髓外疾病或双重难治性疾病（对来那度胺和蛋白酶体抑制剂均难治）的患者亚组中，Dara方案组相对于Pom方案组的优势并不明显。接受Dara方案和DPd方案治疗的患者感染发生率较高（Pom方案组39.6% vs. Dara方案组64.7% vs. DPd方案组70.8%，p = 0.009）。
在真实世界中，Pom方案、Dara方案和DPd方案在RRMM患者中均显示出良好的疗效。与Pom方案相比，Dara方案产生了更好的临床反应和PFS。
