Metadata supporting the published article: Guidelines for managing patients with primary ER+HER2- breast cancer deferred from surgery due to the COVID-19 pandemic.
Creators: name: Dowsett, Mitch
name: Ellis, Matthew J.
name: Dixon, J. Michael
name: Gluz, Oleg
name: Robertson, John
name: Kates, Ronald
name: Suman, Vera J.
name: Turnbull, Arran K.
name: Nitz, Ulrike
name: Christgen, Matthias
name: Kreipe, Hans
name: Kuemmel, Sherko
name: Bliss, Judith M.
name: Barry, Peter
name: Johnston, Stephen R.
name: Jacobs, Samuel A.
name: Smith, Ian
name: Harbeck, Nadia
Publisher: name: figshare
Year: 2020
Subjects: subject: Biological Techniques
subject: Cancer
subject: Infectious Diseases
subject: FOS: Health sciences
subject: Medicine
subject: Cancer Diagnosis
subject: Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
subject: Health Care

description: In this study, the authors have collated data from multiple
international trials of presurgical endocrine therapy in order to provide guidance
on the identification of patients who may have insufficiently
endocrine-sensitive tumors and should be prioritised for early surgery or
neoadjuvant chemotherapy rather than neoadjuvant endocrine therapy (NeoET)
during or in the aftermath of the COVID-19 pandemic for safety or when surgical
activity needs to be prioritized.<br>

 

<b>Data access: </b>The majority of the datasets<b> </b>supporting the findings of this study<b> </b>are derived from clinical trials that
have not yet been published. Other datasets are yet to be published in association
with trial secondary endpoints. For these reasons, the data supporting the findings
of this study are not publicly available, but will be made available on
reasonable request from the corresponding author, Professor Mitch Dowsett,
email: mitchell.dowsett@icr.ac.uk.
Datasets that relate to the Z1031 clinical trial will be made available to researchers
on request, by contacting the ALLIANCE Operations office (email: concepts@allianceNCTN.org)
and completing an Alliance Data Sharing Request Form (https://www.allianceforclinicaltrialsinoncology.org/main/cmsfile?cmsPath=/Public/Datasharing/files/Alliance data sharing request form.pdf).<br>

 

<b>Study approval and patient
consent: </b>All patients
gave informed consent within each of the trials for the derivation of the data
sourced for this study.

The POETIC case-control study was approved by the London-South East Research Ethics Committee. The PALLET trial was
approved by the London-Fulham
Research Ethics Committee. The IL1839/223 trial was approved by the Royal
Marsden Hospital Ethics Committee. The ADAPT HR+/HER2 trial was approved by the
University of Cologne Institutional Review Board.
The Z1031and
ALTERNATE trials were approved by the NCI Central
Institutional Review Board.<br>

 

<b>Study aims and methodology: </b>In many countries severely affected by the COVID-19 pandemic the
surgical management of primary breast cancer is being confined to patients at
highest risk for early disease progression. Thus, surgery for ER+ HER2- tumors
(&gt;70% of the overall breast cancer population) is being frequently deferred
in favour of neoadjuvant endocrine therapy (NeoET) because of patient safety
concerns and resource availability. The accurate identification of patients
most likely to be poorly controlled by NeoET would allow their surgery or
systemic treatment to be prioritised during or in the aftermath of COVID19
according to local circumstances. Conversely, identification of those likely to
experience adequate tumor control by NeoET over a period of surgical deferment
would be reassuring. The immediate objective of this study, was to review the
published data that underpins the application of NeoET in more normal
circumstances and to collate this information with previously unpublished data
from many thousands of patients in ongoing studies to produce a simple
algorithm for patient management.

These are the number of patients that participated in each
trial: POETIC (n=339), PALLET (n=131), IL1839/223 (n= 176), ADAPT HR+/HER2 (n= 3 311), Z1031 (n= 214), ALTERNATE (n= 1299).

 

For
details on immunohistochemical scoring (Ki67, estrogen receptor (ER) and
progesterone receptor (PgR)) and data analyses, please read the related
article.<br>

 

<b>Data supporting the
findings of this study: </b>Dataset
names, formats and data access conditions are described in the data file<b> Dowsett et al.xlsx.</b><br><b>Software needed to access
data: </b>The file<b> </b>Z1031B_ki67.sas requires the SAS statistical
software to be accessed.<b></b><br>