Patel Jai N, Robinson Myra, Jagosky Megan, Slaughter Daniel, Arnall Justin, Jandrisevits Elizabeth, Matusz-Fisher Ashley, Atrash Shebli, Paul Barry, Bhutani Manisha, Voorhees Peter, Usmani Saad Z
Department of Cancer Pharmacology, Levine Cancer Institute/Atrium Health, Charlotte, NC.
Department of Biostatistics, Levine Cancer Institute/Atrium Health, Charlotte, NC.
Clin Lymphoma Myeloma Leuk. 2021 Mar;21(3):188-198.e2. doi: 10.1016/j.clml.2020.11.015. Epub 2020 Nov 28.
We evaluated time to thromboembolism (TE) and risk factors in multiple myeloma (MM) patients after first exposure to immunomodulatory therapy, stratified by thromboprophylaxis.
We retrospectively analyzed adult MM patients who received immunomodulatory therapy with or without dexamethasone between February 2012 and October 2017. Thromboprophylaxis included aspirin, anticoagulants (low-molecular-weight heparin, direct oral anticoagulants, or warfarin), or none. Primary endpoint was time to on-treatment TE by thromboprophylaxis type. Time to TE using death as a competing risk censored at 12 months was used in univariate and multivariable analyses to identify risk factors.
Of 485 evaluable patients, 57% were white and 36% African American; median age was 66. Most received lenalidomide (97.5%) and dexamethasone (90%). Half presented with ≥ 1 comorbidities. Sixty-nine had no documented receipt of prophylaxis, 357 aspirin, and 59 anticoagulation. More patients receiving anticoagulants had ≥ 1 comorbidities compared to aspirin or no-prophylaxis groups (P < .001). There was no difference in 12-month estimated cumulative incidence of TE (7.3%; 95% confidence interval, 5.2-9.9) between thromboprophylaxis groups (none 4.4%, aspirin 8.5%, anticoagulant 3.4%) (P = .24). In multivariable analyses, male sex (hazard ratio, 2.50; 95% confidence interval, 1.21-5.17; P = .014) and presence of any comorbidity (hazard ratio, 2.35; 95% confidence interval, 1.17-4.73; P = .016) were associated with TE incidence; thromboprophylaxis type was not (P = .12).
Male sex and presence of any comorbidity were associated with time to TE. There were no differences in TE incidence between thromboprophylaxis groups despite a higher proportion of those in the anticoagulant group having ≥ 1 comorbidities.
我们评估了接受首次免疫调节治疗的多发性骨髓瘤（MM）患者发生血栓栓塞（TE）的时间及危险因素，并根据血栓预防措施进行分层。
我们回顾性分析了2012年2月至2017年10月期间接受免疫调节治疗（联合或不联合地塞米松）的成年MM患者。血栓预防措施包括阿司匹林、抗凝剂（低分子量肝素、直接口服抗凝剂或华法林）或不采取任何措施。主要终点是根据血栓预防类型确定的治疗期间发生TE的时间。在单变量和多变量分析中，采用将死亡作为12个月时竞争风险进行截尾的TE发生时间来确定危险因素。
在485例可评估患者中，57%为白人，36%为非裔美国人；中位年龄为66岁。大多数患者接受来那度胺（97.5%）和地塞米松（90%）治疗。半数患者伴有≥1种合并症。69例患者未记录接受预防措施，357例接受阿司匹林预防，59例接受抗凝治疗。与阿司匹林或未预防组相比，接受抗凝治疗的患者中伴有≥1种合并症的更多（P <.001）。血栓预防组之间12个月时TE的估计累积发生率无差异（7.3%；95%置信区间，5.2 - 9.9）（未采取措施组为4.4%，阿司匹林组为8.5%，抗凝剂组为3.4%）（P =.24）。在多变量分析中，男性（风险比，2.50；95%置信区间，1.21 - 5.17；P =.014）和存在任何合并症（风险比，2.35；95%置信区间，1.17 - 4.73；P =.016）与TE发生率相关；血栓预防类型与TE发生率无关（P =.12）。
男性和存在任何合并症与发生TE的时间相关。尽管抗凝剂组中伴有≥1种合并症的患者比例较高，但血栓预防组之间的TE发生率无差异。
