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在开始新疗法的复发/难治性多发性骨髓瘤患者中,血清 B 细胞成熟抗原水平的基线和变化迅速表明临床状况的变化。

Baseline and Changes in Serum B-Cell Maturation Antigen Levels Rapidly Indicate Changes in Clinical Status Among Patients with Relapsed/Refractory Multiple Myeloma Starting New Therapy.

机构信息

Institute for Myeloma and Bone Cancer Research, 9201 W. Sunset Blvd., Ste. 300, West Hollywood, CA, 90069, USA.

James R Berenson MD, Inc., West Hollywood, CA, USA.

出版信息

Target Oncol. 2021 Jul;16(4):503-515. doi: 10.1007/s11523-021-00821-6. Epub 2021 Jun 7.

DOI:10.1007/s11523-021-00821-6
PMID:34097243
Abstract

BACKGROUND

B-cell maturation antigen (BCMA) is expressed on malignant plasma cells from patients with multiple myeloma (MM). These patients have higher levels of serum (s)BCMA than healthy subjects, and levels correlate with disease status. The half-life of sBCMA is only 24-36 h, and levels are independent of renal function.

OBJECTIVE

We determined whether baseline sBCMA values, a ≥ 25% increase, and a ≥ 50% decrease during treatment predicted progression-free survival (PFS) and overall survival (OS) among 81 patients with relapsed/refractory MM (RRMM) starting new treatments.

METHODS

Serum was obtained on day 22 of each patient's 28-day cycle of new therapy. Kaplan-Meier survival analysis and log-rank comparison tests were used to determine the effect of baseline sBCMA. The effect of percentage change in sBCMA was investigated using time-dependent Cox proportional hazard models.

RESULTS

Patients with baseline sBCMA levels above the median had a shorter PFS (p = 0.0077), and those in the highest quartile had a shorter PFS (p = 0.0012) and OS (p = 0.0022). A ≥ 25% increase at week 4, week 8, and anytime through week 12 predicted a shorter PFS (p = 0.0011, p = 0.0005, and p < 0.0001, respectively). A ≥ 50% decrease at week 4, week 8, and anytime through week 12 predicted a longer PFS (p = 0.0045, p = 0.029, p = 0.0055, respectively). A ≥ 25% increase in sBCMA occurred before progression according to International Myeloma Working Group criteria in 67.5% of patients.

CONCLUSIONS

Our results indicate the potential for the use of sBCMA as a new biomarker for monitoring patients with RRMM.

摘要

背景

B 细胞成熟抗原 (BCMA) 表达于多发性骨髓瘤 (MM) 患者的恶性浆细胞上。这些患者的血清 (s)BCMA 水平高于健康受试者,且水平与疾病状态相关。sBCMA 的半衰期仅为 24-36 小时,且水平与肾功能无关。

目的

我们在 81 名开始新治疗的复发/难治性 MM (RRMM) 患者中,确定基线 sBCMA 值、治疗期间 sBCMA 值增加≥25%和减少≥50%是否可预测无进展生存期 (PFS) 和总生存期 (OS)。

方法

在新治疗的每个患者 28 天周期的第 22 天采集血清。Kaplan-Meier 生存分析和对数秩检验用于确定基线 sBCMA 的影响。使用时间依赖性 Cox 比例风险模型研究 sBCMA 百分比变化的影响。

结果

基线 sBCMA 水平高于中位数的患者 PFS 更短 (p=0.0077),四分位最高的患者 PFS 更短 (p=0.0012) 和 OS 更短 (p=0.0022)。第 4 周、第 8 周和第 12 周的任何时间点 sBCMA 增加≥25%预测 PFS 更短 (p=0.0011、p=0.0005 和 p<0.0001)。第 4 周、第 8 周和第 12 周的任何时间点 sBCMA 减少≥50%预测 PFS 更长 (p=0.0045、p=0.029 和 p=0.0055)。根据国际骨髓瘤工作组标准,在 67.5%的患者中,sBCMA 增加先于进展。

结论

我们的结果表明,sBCMA 有可能作为监测 RRMM 患者的新生物标志物。

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