Metadata supporting the article: Meta-analyses of visceral versus non-visceral metastases treated by first- and second-line endocrine monotherapies for hormone receptor-positive metastatic breast cancer
Creators: name: John FR Robertson
name: Leo, Angelo Di
name: Johnston, Stephen
name: Chia, Stephen
name: Bliss, Judith M
name: Paridaens, Robert J
name: Lichfield, Jasmine
name: Bradbury, Ian
name: Campbell, Christine
Publisher: name: figshare
Year: 2021
Subjects: subject: 69999 Biological Sciences not elsewhere classified
subject: FOS: Biological sciences
subject: FOS: Biological sciences
subject: Cancer
subject: Medicine
subject: 111204 Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine

description: Meta-analyses were conducted as part of the current study. These meta-analyses included available data from randomised controlled trials of first- and second line endocrine monotherapies for patients with HR+ advanced breast cancer (ABC). In one and two-stage meta-analyses, progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR) and duration of clinical benefit (DoCB) outcomes were analysed.<br><b>Patient consent:</b> Consent to use/analyse patients’ clinical data was obtained from the patients. <br><b>Data access</b>: The file names and sources for all the original clinical trial data used in the meta-analyses, are included in the file <b>Robertson JFR et al.xlsx</b>. The datasets that support the findings of this study are not publicly available, but will be made available upon reasonable request from the corresponding author, Prof John Robertson, email address: <b>John.Robertson@nottingham.ac.uk</b>. The data may be obtained upon request for specific use as long as the request is in keeping with the terms of the agreement under which the University of Nottingham received the data. In accordance with the agreement under which Nottingham University gained approval to use the data, permission for sharing the data beyond those permitted in the agreement is not approved. The SAS analysis file listed in Robertson JFR et al.xlsx, will not be made available, as a condition of the agreement to obtain the data was that they be encrypted during the work and removed completely from the encrypted workspace once the project was completed.<br><b>Study aims and methodology:</b> The majority of breast cancers (BCs) are hormone receptor-positive (HR+), and of those who develop metastatic disease, many develop visceral metastases (VM). In patients with HR+ advanced BC (ABC), those with VM are considered to have poorer prognosis than patients whose disease is limited to non-visceral metastases (non-VM).This meta-analysis aimed to ascertain where maximal benefit can be derived from endocrine monotherapy, by evaluating the clinical efficacy of different endocrine monotherapies in different patient subgroups; fulvestrant (a SERD), tamoxifen (a SERM) and aromatase inhibitors (AIs) in the first- and second-line treatment of patients with HR+ ABC with VM and with non-VM.The authors wanted to prospectively test the following: i) Whether, in both first- and second-line settings, endocrine therapy (ET) was more efficacious in patients whose disease involved non-VM sites, compared with those where VM sites were involved.ii) If a difference was observed in i), whether the response between patients with visceral non-liver metastases (VnLM) and patients with visceral liver metastases (VLM) was different.iii) If a difference was observed in ii), how does ET compare in non-VM and VnLM versus VLM?iv) Assess whether any differences in i) to iii) above were generic to all ETs or specific to a particular class(es) of ET (i.e. SERD, SERM or AI).Anonymised, individual patient data (IPD) or aggregated data were obtained from studies involving SERD, SERM and AI monotherapy in the first- and second-line settings in patients with HR+ ABC. Studies with available IPD or aggregated data were included. Seven randomised controlled trials (RCTs) were included in the first-line meta-analysis, including five double-blind, placebo-controlled RCTs. Postmenopausal women with HR+ (estrogen receptor [ER] or progesterone receptor-positive), locally advanced or metastatic BC were included.For more details on the first-line and second-line meta-analysis, the patients included, and the meta-analyses, please refer to the related article.Studies included in the first-line meta-analysis: EORTC, Study 0025, Study 0027, Study 0030, FIRST, FALCON and CONFIRM.Studies included in the second-line meta-analysis: Study 0020, Study 0021, EFECT, SoFEA, FINDER1, FINDER2 and CONFIRM.First-line meta-analysis included seven trials and 1988 patients, second-line meta-analysis included seven trials and 2324 patients.<br><b>Datasets supporting the findings of this study</b>: The file names and descriptions for all the original clinical trial data used in the analyses, are included in the file <b>Robertson JFR et al.xlsx.</b><br>