Levine Cancer Institute, Charlotte, NC, USA.
Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Deloitte Tower, Suite 1500, Montreal, QC, H3B 0G7, Canada.
BMC Cancer. 2021 Nov 12;21(1):1207. doi: 10.1186/s12885-021-08881-7.
Daratumumab, a CD38 monoclonal antibody, has demonstrated efficacy as monotherapy and combination therapy across several indications, both among newly-diagnosed and refractory patients with multiple myeloma (MM). However, there is limited evidence on treatment patterns and effectiveness of daratumumab in the real-world setting, particularly in first line (1 L). This study aimed to describe real-world treatment patterns and clinical outcomes among patients initiating daratumumab across different lines of therapy.
A retrospective chart review of adult patients with MM initiating daratumumab between November 2015 and March 2021 was conducted at two clinical sites in the United States. De-identified patient-level data were abstracted in an electronic case report form. Patient characteristics and treatment patterns were described. Clinical outcomes including overall response rate (ORR), progression-free survival, and time to next line of therapy were reported using descriptive statistics and stratified by line of therapy (1 L, second line [2 L] or third line or later [3 L+]). A sub-group analysis evaluated treatment patterns and ORR among patients re-treated with daratumumab.
A total of 299 patients were included in the study (mean age: 68 years; 55% male). Among them, 26 were 1 L patients, 66 were 2 L patients, and 207 were 3 L+ patients; 110 patients (36.8%) received a stem cell transplant prior to daratumumab initiation. The mean duration of follow-up was 10 months among 1 L patients and 19 months among 2 L and 3 L+ patients. Patients who initiated daratumumab in 1 L had a 100% ORR, while those initiating in 2 L and 3 L+ had an ORR of 78.8 and 65.2%, respectively. Among re-treated patients, ORR was 66.7% during the first treatment segment, and 52.9% during the second treatment segment. Kaplan-Meier rates of progression-free survival at 12 months were 89.9, 75.2, and 53.1% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Kaplan-Meier rates of time to next line of therapy at 12 months were 94.1, 73.4, and 50.0% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively.
These findings suggest that daratumumab-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1 L.
达雷妥尤单抗是一种针对 CD38 的单克隆抗体,已在多种适应症中证明了单药和联合治疗的疗效,包括新诊断和难治性多发性骨髓瘤(MM)患者。然而,在真实世界环境中,特别是在一线治疗(1L)中,关于达雷妥尤单抗的治疗模式和有效性的证据有限。本研究旨在描述在不同治疗线中开始使用达雷妥尤单抗的患者的真实世界治疗模式和临床结局。
在美国的两个临床地点,对 2015 年 11 月至 2021 年 3 月期间开始使用达雷妥尤单抗的成年 MM 患者进行了回顾性病历审查。从电子病历报告表中提取患者水平的匿名数据。描述患者特征和治疗模式。使用描述性统计和按治疗线(1L、二线[2L]或三线或以上[3L+])分层报告总体缓解率(ORR)、无进展生存期和下一线治疗时间的临床结局。亚组分析评估了重新接受达雷妥尤单抗治疗的患者的治疗模式和 ORR。
本研究共纳入 299 例患者(平均年龄:68 岁;55%为男性)。其中,26 例为 1L 患者,66 例为 2L 患者,207 例为 3L+患者;110 例(36.8%)在开始使用达雷妥尤单抗前接受了干细胞移植。1L 患者的中位随访时间为 10 个月,2L 和 3L+患者的中位随访时间为 19 个月。在 1L 中开始使用达雷妥尤单抗的患者的 ORR 为 100%,而在 2L 和 3L+中开始使用达雷妥尤单抗的患者的 ORR 分别为 78.8%和 65.2%。在重新治疗的患者中,第一个治疗阶段的 ORR 为 66.7%,第二个治疗阶段的 ORR 为 52.9%。在开始使用达雷妥尤单抗的 1L、2L 和 3L+患者中,12 个月时无进展生存期的 Kaplan-Meier 率分别为 89.9%、75.2%和 53.1%。在开始使用达雷妥尤单抗的 1L、2L 和 3L+患者中,12 个月时下一线治疗时间的 Kaplan-Meier 率分别为 94.1%、73.4%和 50.0%。
这些发现表明,达雷妥尤单抗为基础的治疗方案在所有治疗线中均为有效治疗选择,在 1L 中具有最高的缓解率。