Metadata supporting the article: De-Escalation of Radiation Therapy in Patients with Stage I, Node-Negative, HER2- Positive Breast Cancer
Creators: name: Bazan, Jose G.
name: Jhawar, Sachin R.
name: Stover, Daniel
name: Park, Ko Un
name: Beyer, Sasha
name: Healy, Erin
name: White, Julia R.
Publisher: name: figshare
Year: 2021
Subjects: subject: 69999 Biological Sciences not elsewhere classified
subject: FOS: Biological sciences
subject: FOS: Biological sciences
subject: Cancer
subject: 111208 Radiation Therapy
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: Medicine

description: In the modern era, highly effective anti-HER2 therapy is associated with low local-regional recurrence (LRR) rates for early-stage HER2+ breast cancer raising the question of whether local therapy de-escalation by radiation omission is possible in patients with small-node negative tumors treated with lumpectomy. In this study, the authors sought to identify whether radiation omission has a measurable effect on overall survival in patients with T1N0 HER2+ breast cancer (BC) treated with lumpectomy, adjuvant chemotherapy, and anti-HER2 therapy.<br> <b>Data access</b>: The data that support the findings of this study are available from the National Cancer Database, but restrictions apply to the availability of these data, which are not publicly available. The original data from the National Cancer Data Base, as well as the derived analysis dataset, will be made available to researchers at the Commission on Cancer (CoC) centres, who have completed an application form and a Data Usage Agreement. Please contact NCDB_PUF@facs.org for data access requests.<br> <b>Study approval</b>: Since all data are de-identified, this retrospective study was deemed exempt by the Ohio State University Medical Center’s Cancer Institutional Review Board.<br> <b>Study aims and methodology</b>: In this study, the authors evaluated the existing data on radiation omission in HER2+ BC by using the National Cancer Database (NCDB) to test that hypothesis that RT omission results in equivalent overall survival (OS) in stage I (T1N0) HER2+ BC treated with lumpectomy and adjuvant trastuzumab-based systemic therapy. The authors retrospectively reviewed the NCDB, which is a combined effort of the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society. The NCDB is a nationwide hospital-based database that contains de-identified hospital registry data from more than 1,500 accredited facilities and represents more than 70% of newly diagnosed cancer cases in the United States. The NCDB collects data on patient demographics and comorbidities, tumor characteristics and staging details, primary therapies administered, and overall survival. Patients diagnosed with T1N0 HER2+ BC from 2013-2015 were collected from the NCDB participant user file (2013 was the first year in which anti-HER2 therapies were classified as “Immunotherapy” and not “Chemotherapy” in the NCDB). The study included patients treated with lumpectomy, adjuvant chemotherapy and anti-HER2 therapy. Mastectomy patients and those undergoing preoperative systemic therapy were excluded. The authors defined 2 cohorts of patients: radiation omission and radiation received. The entire cohort consisted of 6 897 patients. For more details on the study variables and statistical analysis, please refer to the related article.<br> <b>Data supporting the findings of the study: </b>Dataset <b>her2.sas7bdat</b>.is a <b>SAS data file</b>, and supports all the figures, tables and supplementary tables in the article. This file was derived from statistical analysis (performed using SAS, version 9.4) of the original NCDB data.<b></b>