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在美国,硼替佐米联合来那度胺和地塞米松作为一线治疗方案治疗多发性骨髓瘤且未接受移植的患者的真实世界患者特征和治疗结局。

Real-world patient characteristics and treatment outcomes among nontransplanted multiple myeloma patients who received Bortezomib in combination with Lenalidomide and Dexamethasone as first line of therapy in the United States.

机构信息

Janssen Scientific Affairs, LLC, 800 Ridgeview Drive, Horsham, PA, 19044, USA.

Georgetown University Medical Center, 37th and O Street, NW, Washington, DC, 20057, USA.

出版信息

BMC Cancer. 2022 Aug 18;22(1):901. doi: 10.1186/s12885-022-09980-9.

Abstract

BACKGROUND

There is limited real-world evidence that describes patients with newly diagnosed multiple myeloma (NDMM) treated with the bortezomib, lenalidomide, and dexamethasone (VRd) triplet regimen. We evaluated patient characteristics and treatment outcomes among nontransplanted NDMM patients who received VRd as their first line of therapy (LOT) in US oncology practice settings.

METHODS

This retrospective observational cohort study evaluated patients from the Flatiron MM Core Registry who received VRd as first LOT between November 1, 2015, and February 28, 2021. Progression-free survival (PFS) was analyzed using the Kaplan-Meier method. Associations between patient demographic and clinical characteristics and PFS were evaluated using a multivariable Cox proportional hazards model.

RESULTS

A total of 2342 eligible patients with VRd as first LOT were identified (mean age, 67.0 years). Among all identified patients, 64.3% were ≥ 65 years of age, 25.5% were elderly (≥75 years), and 47.9% were frail. Among patients with available data, 21.2% had high-risk cytogenetics, and the majority had International Staging System (ISS) stage I/II disease (71.8%), and Eastern Cooperative Oncology Group performance status (ECOG PS) score 0/1 (81.2%). Median duration of therapy was 5.5 months. With median follow-up of 21.0 months, median PFS and time-to-next-treatment were 26.5 and 16.1 months, respectively. Higher risk of disease progression or death was seen in patients categorized as elderly (hazard ratio [HR] = 1.37; 95% confidence interval [CI]: 1.13-1.66 vs patients < 65 years), having high-risk cytogenetics (HR = 1.44; 95% CI: 1.19-1.75 vs standard risk), having ISS disease stages II and III (HR = 1.31; 95% CI: 1.06-1.63 and HR = 1.37; 95% CI: 1.10-1.70 versus stage I, respectively), and having worse ECOG PS score (≥2) (HR = 1.49; 95% CI: 1.22-1.81 versus functionally active patients).

CONCLUSIONS

The majority of patients treated with VRd in this study were ≥ 65 years of age, were ISS stage I/II, had an ECOG PS score of 0/1, and had standard cytogenetic risk. Median PFS observed in real-world practice was notably shorter than that observed in the SWOG S0777 clinical trial. In nontransplanted patients treated with VRd as first LOT, a higher risk of disease progression or death was associated with older age, having high-risk cytogenetics, worse disease stage, and worse ECOG PS score.

摘要

背景

目前仅有有限的真实世界证据描述了新诊断多发性骨髓瘤(NDMM)患者接受硼替佐米、来那度胺和地塞米松(VRd)三联方案治疗的情况。我们评估了在美国肿瘤学实践环境中接受 VRd 作为一线治疗(LOT)的未接受移植的 NDMM 患者的患者特征和治疗结局。

方法

本回顾性观察队列研究评估了 2015 年 11 月 1 日至 2021 年 2 月 28 日期间从 Flatiron MM Core Registry 中接受 VRd 作为一线 LOT 的患者。采用 Kaplan-Meier 法分析无进展生存期(PFS)。使用多变量 Cox 比例风险模型评估患者人口统计学和临床特征与 PFS 之间的关联。

结果

共确定了 2342 例符合条件的 VRd 一线 LOT 患者(平均年龄为 67.0 岁)。所有患者中,64.3%的患者年龄≥65 岁,25.5%的患者年龄较大(≥75 岁),47.9%的患者身体虚弱。在有可用数据的患者中,21.2%的患者具有高危细胞遗传学特征,大多数患者具有国际分期系统(ISS)Ⅰ/Ⅱ期疾病(71.8%)和东部肿瘤协作组表现状态(ECOG PS)评分 0/1(81.2%)。中位治疗持续时间为 5.5 个月。中位随访 21.0 个月时,中位 PFS 和下一次治疗时间分别为 26.5 个月和 16.1 个月。在被归类为老年患者(危险比 [HR] = 1.37;95%置信区间 [CI]:1.13-1.66 与<65 岁的患者相比)、具有高危细胞遗传学特征(HR = 1.44;95%CI:1.19-1.75 与标准风险相比)、具有 ISS 疾病分期 II 和 III(HR = 1.31;95%CI:1.06-1.63 和 HR = 1.37;95%CI:1.10-1.70 与 I 期相比)和 ECOG PS 评分较差(≥2)(HR = 1.49;95%CI:1.22-1.81 与功能活跃的患者相比)的患者中,疾病进展或死亡的风险更高。

结论

在这项研究中,接受 VRd 治疗的大多数患者年龄≥65 岁,ISS 分期为Ⅰ/Ⅱ期,ECOG PS 评分为 0/1,细胞遗传学风险标准。在真实世界实践中观察到的中位 PFS 明显短于 SWOG S0777 临床试验中的中位 PFS。在接受 VRd 作为一线 LOT 治疗的未接受移植的患者中,疾病进展或死亡的风险较高与年龄较大、具有高危细胞遗传学特征、疾病分期较差和 ECOG PS 评分较差有关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcee/9386920/a385ea5254e9/12885_2022_9980_Fig1_HTML.jpg

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