Metadata supporting the published article: Prognostic significance of residual nodal disease after neoadjuvant endocrine therapy for hormone receptor-positive breast cancer
Creators: name: Kantor, Olga
name: Wong, Stephanie
name: Weiss, Anna
name: Metzger, Otto
name: Mittendorf, Elizabeth A
name: Tari A King
Publisher: name: figshare
Year: 2020
Subjects: subject: Cancer
subject: Pathology
subject: 111204 Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: Medicine

description: Axillary management after neoadjuvant endocrine therapy (NET) has not been well studied and the significance of residual axillary node disease after NET remains uncertain. In this study, the authors used the National Cancer Data Base to examine the prognostic significance of residual nodal disease after NET.<br><b>Data access</b>: The data from the National Cancer Data Base used during the current study, are not publicly available. The data 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 <b>NCDB_PUF@facs.org</b> for data access requests. <br> <b>Study approval</b>: Data are compliant with the Health Insurance Portability and Accountability Act (HIPAA). As all data are de-identified, this study was deemed to be IRB exempt by the Brigham and Women’s Hospital Institutional Review Board.<br><b>Study aims and methodology</b>: Given that patients undergoing neoadjuvant chemotherapy (NAC) have received the majority of their systemic therapy prior to surgery, whereas those who receive NET have received only a short course of therapy (3-6 months) and continue to benefit from endocrine therapy in the adjuvant setting, the authors hypothesized that residual axillary node disease after NET would not carry the same prognostic implications as residual nodal disease after NAC. Here the authors used the National Cancer Data Base (NCDB) to explore the prognostic significance of residual nodal disease in both cN0 (No regional lymph node metastases) and cN1 (Metastases to movable ipsilateral Level I, II axillary lymph nodes(s).) patients selected for NET.<br>The NCDB is a joint project of the American Cancer Society and the American College of Surgeons Commission on Cancer, which captures approximately 70% of new cancer diagnoses in the United States. Variables include patient demographics (age, race, comorbidities), tumor characteristics (histology, grade, lymphovascular invasion, clinical and pathologic stage), treatment characteristics (surgery, radiation, systemic therapy, and timing of therapies), and overall survival. Breast cancer site-specific factors include estrogen receptor, progesterone receptor and HER2 receptor status.Selection criteria included female patients with minimal comorbidities (Charlson-Deyo index of &lt;2) who underwent NET for HR+HER2- clinical stage T1-3N0-1M0 breast cancer from 2010-2016 followed by breast and axillary surgery. Patients with missing information regarding systemic therapy or nodal pathology were excluded. Patients treated with concurrent or subsequent neoadjuvant chemotherapy were also excluded. NET was defined as endocrine therapy duration for at least 30 days and no longer than 1 year prior to the date of surgery. American Joint Committee on Cancer 7th edition staging was used for determination of clinical and pathologic stage groups.For more details on the methodology, please read the related article.<br><b>Data supporting the figures, tables and supplementary tables in the published article:</b> The file <b>NCDB Breast PUF 2016.sav</b> is in. sav file format, and contains the raw as well as the analysed data that support the findings of this study. The data file includes data on overall survival, clinical characteristics, and residual nodal disease burden after NET in HR+HER2- patients.<br><b>Software needed to access data:</b> The SPSS statistics software is required to access and analyse the data in NCDB Breast PUF 2016.sav.<br>