Utilization and impact of 21-gene recurrence score assay for breast cancer in clinical practice across the United States: lessons learned from the 2010 to 2012 National Cancer Data Base analysis.
Utilization and impact of 21-gene recurrence score assay for breast cancer in clinical practice across the United States: lessons learned from the 2010 to 2012 National Cancer Data Base analysis.
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在美国临床实践中，对乳腺癌的21基因复发评分测定法的利用和影响：从2010年到2012年的国家癌症数据库分析中学到的经验教训。
DOI：
10.1007/s10549-016-3833-9
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发表时间：
2016-06
影响因子：
3.8
通讯作者：
Bell JL
中科院分区：
文献类型：
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作者：
Orucevic A;Heidel RE;Bell JL
我们的研究目的是通过对2010 - 2012年美国国家癌症数据库（NCDB）患者的回顾性观察研究，探讨乳腺癌（BC） 21基因复发评分法（RS）的患者选择以及RS对临床实践中化疗给药（Chemo）的影响。在美国，ndb每年捕获约70%的新诊断恶性肿瘤。2010-2012年期间描述的数据是从NCDB开始需要记录分子分析及其数据于2015年4月发布的数据。分析有RS结果的患者的去识别的人口学和临床变量。513,080例患者患有BC；雌激素受体阳性（ER+） 406525例。74,334/91,651例RS记录为数值（0-100）进行分析（占ER+的18.2%）。患者年龄18 ~ 90岁（平均58.8岁，中位数59岁）；99.1%为女性。来自未接受过高中教育的地区的白种人患者（低于7%）和家庭收入中位数低于63,000美元的患者比其他种族、教育程度或收入的患者更有可能接受检测（p < 0.001）。58.1%的检查是在ER+/淋巴结阴性/> 1cm肿瘤中进行的；≥N1病占16.4%；9.9%为T1a、T3、III期和IV期或her2阳性癌症。低危RS结果阴性预测值为92.2%。中危RS阳性预测值（PPV）为40.1%；高危RS化疗组PPV为81.2%。在美国，约1/5的ER + BC患者出现RS。有必要进一步研究最新循证管理指南对患者RS检测选择和获得检测结果后化疗给药的影响和实施情况。
The aim of our study is to investigate patient selection for the 21-gene recurrence score assay (RS) for breast cancer (BC) and the RS impact on chemotherapy administration (Chemo) in clinical practice across the United States through the retrospective observational study of National Cancer Data Base (NCDB) patients from 2010 to 2012. NCDB captures ~70 % of all newly diagnosed malignancies in the USA annually. The 2010–2012 period depicts data from the beginning of the NCDB that required recording of molecular assays and their data release in April 2015. De-identified demographic and clinical variables of patients that had RS results were analyzed. 513,080 patients had BC; 406,525 were estrogen receptor-positive (ER+). 74,334/91,651 patients with RS recorded as a numerical value (0–100) were analyzed (18.2 % of ER+). Patients’ ages ranged from 18 to 90 (mean = 58.8, median = 59); 99.1 % were females. Patients of Caucasian race, from regions with <7 % having no high school education, and >$63,000 median household income were more likely to be tested than patients of other races, education, or income (p < 0.001). 58.1 % of tests were performed in ER+/lymph node-negative/>1 cm tumors; 16.4 % included ≥N1 disease; 9.9 % included T1a, T3, Stage III and IV, or HER2-positive cancers. Low-risk RS result had 92.2 % negative predictive value for no Chemo. Intermediate-risk RS result had 40.1 % positive predictive value (PPV); high-risk RS had 81.2 % PPV for Chemo. RS is obtained in ~1/5 of ER + BC patients across the USA. Further studies investigating influence and implementation of the newest evidence-based management guidelines regarding patients’ selection for RS test and chemotherapy administration upon obtaining of test results are warranted.