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在监管和报销政策变化的背景下,癌症患者促红细胞生成素刺激剂(ESAs)和红细胞输血使用情况的变化。

Changes in the use of erythropoiesis-stimulating agents (ESAs) and red blood cell transfusion in patients with cancer amidst regulatory and reimbursement changes.

作者信息

Gawade Prasad L, Berlin Jesse A, Henry David H, Tomita Dianne, Brooks Barry D, Franklin Janet, Bradbury Brian D, Critchlow Cathy W

机构信息

Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.

Epidemiology, Johnson & Johnson, New Brunswick, NJ, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1357-1366. doi: 10.1002/pds.4293. Epub 2017 Aug 14.

Abstract

PURPOSE

Evaluate changes in use of erythropoiesis-stimulating agents (ESAs) and red blood cell transfusion in cancer patients receiving myelosuppressive chemotherapy following regulatory and reimbursement actions.

METHODS

Calendar year patient cohorts (2005-2013) with breast, colorectal, lung, multiple myeloma, non-Hodgkin lymphoma, ovarian, or prostate cancer and receiving myelosuppressive chemotherapy were identified within the Marketscan database. Incidence of ESA treatment and transfusion were estimated in each year, as was median number of ESA administrations. Clinical characteristics associated with ESA administration and transfusions were evaluated by using multivariable logistic regression. Additionally, annual new ESA user cohorts within the Oncology Services Comprehensive Electronic Records database (2011-2014) were examined to assess hemoglobin levels at ESA initiation.

RESULTS

Across all tumor types, ESA use decreased substantially (breast cancer: 53.7 to 3.2%; lung cancer: 66.0 to 13.3%, non-Hodgkin lymphoma: 39.8 to 3.8%), transfusion use increased (2 to 5.5%, 5.5 to 18.2%, and 4.5 to 9.1%, respectively), and median number of ESA administrations declined. Across all tumor types, proportion of patients initiating an ESA with hemoglobin >10 g/dL was <10% from 2011 onward. In recent years, cancer patients who are older, female, and have chronic kidney disease or moderate or severe liver disease were most likely to receive ESAs.

CONCLUSION

Subsequent to important regulatory and reimbursement ESA-related actions, total ESA exposure among cancer patients receiving myelosuppressive chemotherapy declined substantially. Today, fewer patients receive ESA therapy, and among those treated, more are initiated at hemoglobin levels <10 g/dL and are exposed for a shorter duration, consistent with current product labeling.

摘要

目的

评估在监管和报销措施实施后,接受骨髓抑制性化疗的癌症患者使用促红细胞生成素(ESA)和红细胞输血的情况变化。

方法

在Marketscan数据库中确定2005 - 2013年接受骨髓抑制性化疗的乳腺癌、结直肠癌、肺癌、多发性骨髓瘤、非霍奇金淋巴瘤、卵巢癌或前列腺癌患者队列。估计每年ESA治疗和输血的发生率以及ESA给药的中位数。通过多变量逻辑回归评估与ESA给药和输血相关的临床特征。此外,对肿瘤服务综合电子记录数据库(2011 - 2014年)中的年度新ESA用户队列进行检查,以评估开始使用ESA时的血红蛋白水平。

结果

在所有肿瘤类型中,ESA的使用大幅下降(乳腺癌:从53.7%降至3.2%;肺癌:从66.0%降至13.3%,非霍奇金淋巴瘤:从39.8%降至3.8%),输血使用增加(分别从2%增至5.5%、从5.5%增至18.2%和从4.5%增至9.1%),且ESA给药的中位数下降。从2011年起,在所有肿瘤类型中,血红蛋白>10 g/dL时开始使用ESA的患者比例<10%。近年来,年龄较大、女性、患有慢性肾病或中度或重度肝病的癌症患者最有可能接受ESA治疗。

结论

在与ESA相关的重要监管和报销措施实施后,接受骨髓抑制性化疗的癌症患者的总ESA暴露量大幅下降。如今,接受ESA治疗的患者减少,且在接受治疗的患者中,更多患者开始使用ESA时的血红蛋白水平<10 g/dL,暴露时间更短,这与当前的产品标签一致。

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