Metadata supporting data files in the published article: Ten-year clinical outcomes in N0 ER+ breast cancer patients with Recurrence Score-guided therapy
Creators: name: Stemmer, Salomon M.
name: Steiner, Mariana
name: Rizel, Shulamith
name: Ben-Baruch, Noa
name: Uziely, Beatrice
name: Jakubowsk, Debbie M.
name: Baron, Julie
name: Shak, Steven
name: Soussan-Gutman, Lior
name: Bareket-Samish, Avital
name: Fried, Georgeta
name: Rosengarten, Ora
name: Itay, Amit
name: Nisenbaum, Bella
name: Katz, Daniela
name: Leviov, Michelle
name: Tokar, Margarita
name: Liebermann, Nicky
name: Geffen, David B.
Publisher: name: figshare
Year: 2019
Subjects: subject: Cancer
subject: Medicine
subject: 111205 Chemotherapy
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: 111299 Oncology and Carcinogenesis not elsewhere classified

description: The authors performed exploratory analysis of the Clalit Health Services (CHS) registry which included all CHS patients with node-negative estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) who underwent Recurrence Score (RS) testing between 1/2006 and 12/2009, to determine 10-year Kaplan-Meier estimates for distant recurrence/BC specific mortality (BCSM) in this cohort. The analysis included 1365 patients.<br><b>Data access:</b> Dataset <b>Stemmer Ms dataset.xlsx</b> supporting all the figures, tables and supplementary files in the published article, is not publicly available in order to protect patient privacy, but can be accessed from the corresponding author on request, upon the completion of a Data Usage Agreement. Requests should be addressed to Prof. Salomon M. Stemmer, Head of the Research Unit at Davidoff Center, Rabin Medical Center, 39 Jabotinski St., Petah Tikva, 49414, Israel. Phone: +972-3-9378005; Fax: +972-3-9378045; <b>stemmer@post.tau.ac.il</b>.<br><b>Study approval: </b>The study was approved by the institutional review boards of the CHS Community Division and participating medical centers, and was granted a waiver for obtaining patient consent. The study was conducted in accordance with the Declaration of Helsinki.<br><b>Study aims and methodology:</b> It is well established that ER+ BC patients, have a protracted recurrence risk with approximately half of all distant recurrences occurring after 5 years and a continuum of relapse until 20 years. The 21-gene Oncotype DX Breast Recurrence Score® assay is a validated prognostic/predictive tool used to guide adjuvant treatment decisions in estrogen receptor (ER)+ HER2-negative early breast cancer (BC). The assay has been further validated with data from 2 phase 3 trials (TAILORx, WSG-PlanB). Clalit Health Services (CHS), the largest health maintenance organisation (HMO) in Israel, started reimbursing the assay in 2006. The goal of this study was to analyse the maturing data from the CHS registry, and to investigate 10-year distant recurrence/BCSM rates using the TAILORx RS categorization.<br>The following data sources were used for the study: The Teva Pharmaceutical Industries database (for RS results and patient/tumor characteristics); medical records and CHS claims information (for treatments received and recurrence/death). Those extracting the clinical information were unaware of the RS result.The log-rank test was used to compare 10-year Kaplan Meier estimates for distant recurrence rates (primary endpoint) and 10-year BCSM (secondary endpoint) between RS groups. Hazard ratios (HR) and 95% confidence intervals (CI) values were calculated using Cox regression models to evaluate the association of RS group, age, tumor size, and grade with distant recurrence.For more details on the methodology and statistical analyses, please read the published article.<br><b>Dataset description:</b> Dataset <b>Stemmer Ms dataset.xlsx</b> is in <b>Excel</b> file format and supports figures 1-4, table 1, all the supplementary figures and supplementary table 1 in the published article. This dataset includes treatment, distant recurrence, and BCSM data, as well as baseline patient and tumour characteristics<br><br> <br>