PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
背景：评估基于泊马度胺（Pom-based）与基于达拉图单抗（Dara-based）治疗复发/难治性多发性骨髓瘤（RRMM）患者的疗效的比较研究仍然很少，在随机对照试验和真实世界研究中。
方法：这项回顾性队列研究包括2018年12月至2023年7月在中国三甲医院接受Pom基或Dara基或泊马度胺和达拉图单抗（DPd）联合治疗的140例RRMM患者。
结果：基于Pom的总体响应率（ORR）（n=48），基于达拉（n=68），DPd(n=24)组为57.8%，84.6%,75.0%,分别(p=0.007)。在2023年8月1日的数据截止时，基于Pom的组的中位无进展生存期（PFS）为5.7个月（95％CI：5.0-6.5），10.5个月(5.2-15.8)，DPd组（p=0.056）为6.7个月（4.0-9.3）。多变量分析确定的治疗方案（基于Dara的与基于Pom的，DPdvs.以Pom为基础）和东部肿瘤协作组表现状态（ECOGPS）作为PFS的独立预后因素。在年龄>65岁的患者亚组中，ECOGPS≥2，治疗线≥2，髓外疾病或双重难治性疾病（来那度胺和蛋白酶体抑制剂均难治性），基于Dara的方案相对于基于Pom的方案的优越性并不明显.在接受基于Dara和DPd方案的患者中观察到更高的感染发生率（基于Pom的39.6％与基于达拉的64.7%与DPd70.8%,p=0.009)。
结论：在现实世界中，基于Pom的，以达拉为基础，和DPd疗法在RRMM患者中表现出良好的疗效。与基于Pom的治疗相比，基于Dara的治疗产生了更好的临床反应和PFS。
方法：这项回顾性队列研究包括2018年12月至2023年7月在中国三甲医院接受Pom基或Dara基或泊马度胺和达拉图单抗（DPd）联合治疗的140例RRMM患者。
结果：基于Pom的总体响应率（ORR）（n=48），基于达拉（n=68），DPd(n=24)组为57.8%，84.6%,75.0%,分别(p=0.007)。在2023年8月1日的数据截止时，基于Pom的组的中位无进展生存期（PFS）为5.7个月（95％CI：5.0-6.5），10.5个月(5.2-15.8)，DPd组（p=0.056）为6.7个月（4.0-9.3）。多变量分析确定的治疗方案（基于Dara的与基于Pom的，DPdvs.以Pom为基础）和东部肿瘤协作组表现状态（ECOGPS）作为PFS的独立预后因素。在年龄>65岁的患者亚组中，ECOGPS≥2，治疗线≥2，髓外疾病或双重难治性疾病（来那度胺和蛋白酶体抑制剂均难治性），基于Dara的方案相对于基于Pom的方案的优越性并不明显.在接受基于Dara和DPd方案的患者中观察到更高的感染发生率（基于Pom的39.6％与基于达拉的64.7%与DPd70.8%,p=0.009)。
结论：在现实世界中，基于Pom的，以达拉为基础，和DPd疗法在RRMM患者中表现出良好的疗效。与基于Pom的治疗相比，基于Dara的治疗产生了更好的临床反应和PFS。
