Real-world evidence analysis of palbociclib prescribing patterns for patients with advanced/metastatic breast cancer treated in community oncology practice in the USA one year post approval.
Real-world evidence analysis of palbociclib prescribing patterns for patients with advanced/metastatic breast cancer treated in community oncology practice in the USA one year post approval.
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DOI：
10.1186/s13058-018-0958-2
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发表时间：
2018-05-02
期刊：
影响因子：
--
通讯作者：
Feinberg BA
中科院分区：
文献类型：
--
作者：
Kish JK;Ward MA;Garofalo D;Ahmed HV;McRoy L;Laney J;Zanotti G;Braverman J;Yu H;Feinberg BA
对癌症生物学快速发展的理解为将这种理解转化为临床相关治疗提供了新的机会。Palbociclib是一种新型的、同类第一的细胞周期蛋白依赖性激酶（CDK） 4/6抑制剂，于2015年2月在美国被批准用于治疗晚期/转移性乳腺癌。我们在批准后的第一年检查了真实世界的证据，以了解社区肿瘤实践中接受palbociclib治疗的患者的临床和人口学特征以及剂量、治疗和全血细胞计数（CBC）监测模式。这是一项来自美国电子病历（EMR）数据库的结构化数据的回顾性观察研究。2015年1月31日之后接受帕博西尼治疗的女性患者随访至2016年3月31日。我们的方法学规则是根据给药的顺序来汇总收到的药物，即，使用EMR中的治疗顺序和疗程描述字段，确定治疗线为一线、二线或三线等。有763例患者开始使用帕博西尼，符合选择标准。其中612例（80.2%）接受帕博西尼联合来曲唑治疗。平均随访6.4个月，帕博西尼起始时的平均年龄为64岁。在已知起始剂量的患者中（n = 417）， 79.9%的患者开始使用帕博西尼125mg。20.1%的患者出现剂量减少。在帕博西尼开始治疗时，根据一线治疗的患者百分比为39.5%；二线,15.7%;线,13.1%;第四线或更晚的治疗，31.7%。在帕博西尼治疗的第一个周期中，平均进行两次CBC检测。总体而言，74.6%的患者在随访期间发生中性粒细胞减少事件，其中3级和4级分别为47.3%和8.0%。美国批准帕博西尼一年后的实际使用表明，患者群体比临床试验中研究的更加异质性，超过一半的患者在后期治疗中接受帕博西尼加来曲唑。CBC检测率表明良好的提供者遵守美国处方信息的监测指南。3级和4级中性粒细胞减少的发生率（基于实验室结果）与两项iii期研究中的3级和4级中性粒细胞减少率一致（PALOMA-2分别为56%和10%；PALOMA-3分别为55%和11%）。了解palbociclib在现实世界患者中的使用情况，以及如何给药和监测，有助于了解该药物的安全有效使用。本文的在线版本（10.1186/s13058-018-0958-2）包含补充资料，仅供授权用户使用。
Rapidly evolving understanding of cancer biology has presented novel opportunities to translate that understanding into clinically relevant therapy. Palbociclib, a novel, first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor was approved in the USA in February 2015 for the treatment of advanced/metastatic breast cancer. We examined real-world evidence in the first year post approval to understand the clinical and demographic characteristics of patients treated with palbociclib in community oncology practices and the dosing, treatment, and complete blood count (CBC) monitoring patterns. This was a retrospective observational study of structured data from a US electronic medical record (EMR) database. Female patients receiving palbociclib after 31 January 2015 were followed through 31 March 2016. Our methodological rules were constructed to aggregate drugs received according to the order in which they are given, i.e., identify the line of therapy as first, second, or third line, etc., using treatment order and course description fields from the EMR. There were 763 patients initiating palbociclib who met the selection criteria. Of those, 612 (80.2%) received palbociclib concomitantly with letrozole. Mean follow up was 6.4 months and mean age at palbociclib initiation was 64 years. Of patients with a known starting dose (n = 417), 79.9% started on palbociclib 125 mg. Dose reductions were observed in 20.1% of patients. Percentages of patients according to line of therapy at initiation of palbociclib were first-line, 39.5%; second-line, 15.7%; third-line, 13.1%; and fourth-line therapy or later, 31.7%. On average, two CBC tests were conducted during the first cycle of palbociclib treatment. Overall, 74.6% of patients had a neutropenic event during follow up including 47.3% and 8.0% of patients with a grade 3 or 4 occurrence, respectively. Real-world palbociclib use one year post US approval demonstrates a more heterogeneous patient population than that studied in the clinical trials with more than half of the patients receiving palbociclib plus letrozole in later lines of therapy. CBC testing rates suggested good provider compliance with monitoring guidelines in the USA prescribing information. The occurrence of grade 3 and 4 neutropenia (based on laboratory results) was consistent with the rates of grade 3 and 4 neutropenia in two phase-III studies (PALOMA-2, 56% and 10%; PALOMA-3, 55% and 11%, respectively). Understanding palbociclib utilization in real-world patients and how drug dosing and monitoring are performed aids in the understanding of safe and effective use of the drug. The online version of this article (10.1186/s13058-018-0958-2) contains supplementary material, which is available to authorized users.
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影响因子：
254.7
作者：
Siegel, Rebecca;Ma, Jiemin;Jemal, Ahmedin
通讯作者：
Jemal, Ahmedin
影响因子：
51.1
作者：
Finn, Richard S.;Crown, John P.;Slamon, Dennis J.
通讯作者：
Slamon, Dennis J.
DOI：
10.1186/s13058-015-0661-5
发表时间：
2016-02-09
期刊：
Breast cancer research : BCR
影响因子：
--
作者：
Finn RS;Aleshin A;Slamon DJ
通讯作者：
Slamon DJ
影响因子：
51.1
作者：
Cristofanilli, Massimo;Turner, Nicholas C.;Slamon, Dennis
通讯作者：
Slamon, Dennis
影响因子：
158.5
作者：
Finn, Richard S.;Martin, Miguel;Slamon, Dennis J.
通讯作者：
Slamon, Dennis J.