Metadata supporting the article: Immune microenvironment and intrinsic subtyping in hormone receptor-positive/ HER2-negative breast cancer
Creators: name: Griguolo, Gaia
name: Dieci, Maria Vittoria
name: Paré, Laia
name: Miglietta, Federica
name: Generali, Daniele Giulio
name: Frassoldati, Antonio
name: Cavanna, Luigi
name: Bisagni, Giancarlo
name: Piacentini, Federico
name: Tagliafico, Enrico
name: Cagossi, Katia
name: Ficarra, Guido
name: Aleix Prat
name: Conte, Pierfranco
name: Guarneri, Valentina
Publisher: name: figshare
Year: 2021
Subjects: subject: Biological Techniques
subject: 69999 Biological Sciences not elsewhere classified
subject: FOS: Biological sciences
subject: FOS: Biological sciences
subject: Cancer
subject: 111201 Cancer Cell Biology
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: 111203 Cancer Genetics
subject: Medicine

description: Little is known regarding the interaction between immune microenvironment and tumor biology in hormone-receptor (HR)+/HER2- breast cancer (BC). In this study, the authors assessed pre-treatment gene-expression data from 66 HR+/HER2- early BCs from the LETLOB trial (NCT00422903). The gene expression data analyzed during this study, were generated during the LETLOB trial.<br> <b>Data access</b>: The datasets that support the findings of this study are not publicly available in order to protect patient privacy. The data will be available on reasonable request from the corresponding author, Dr. Maria Vittoria Dieci, email address: mariavittoria.dieci@unipd.it. <br> <b>Study approval and patient consent: </b>All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Patients provided written informed consent.<br> <b>Study aims and methodology: </b>Hormone receptor positive/HER2-negative (HR+/HER2-) breast cancers (BC) account for almost two-thirds of BC diagnoses1 and are well-known to be a clinically heterogenous subgroup of BCs. Two methodologies, gene-expression profiling and assessment of immune microenvironment, have significantly impacted our understanding of biological heterogeneity in HR+/HER2- BC. In this study, the authors assessed TIL levels and immune infiltrate composition according to intrinsic subtyping in post-menopausal HR+/HER2- BC patients enrolled in a phase-II randomized neoadjuvant trial of letrozole+/-lapatinib (LETLOB trial). The LETLOB trial (NCT00422903, first posted on clinicaltrials.gov January 17, 2007) is a multicenter, phase II trial which randomized 92 HR+/HER2- postmenopausal BC patients (stage II-IIIA; T&gt;2 cm, N0-1, M0) to receive letrozole 2.5 mg daily plus lapatinib 1500 mg daily (arm A) or placebo (arm B) for 6 months. Previously published study results have shown that the combination of letrozole-lapatinib is feasible and results in similar overall clinical response rate and effect on Ki67 as compared to letrozole-placebo. As part of the original study protocol, pre-treatment frozen core-biopsies and FFPE tumor samples from both diagnostic core-biopsies and surgical samples were collected. TIL levels were centrally evaluated following consensus guidelines on H&amp;E stained slides from both diagnostic core biopsies and surgical, as previously published. As part of the original study protocol, RNA was extracted from pretreatment frozen core biopsies and assessed using a Affymetrix GeneChip 3′, as previously reported. Adequate gene-expression data was available for 66 out of 92 patients enrolled. For more details on the methodology, please refer to the original article.<br> <b>Data supporting the related article: </b> Data supporting figures 1, 2, supplementary figure 1 and supplementary tables 1, 2, 4, 5, 6: <b>LETLOB_CIBERSORT_PAM50_22062020.txt</b>, in .txt file format. Data supporting supplementary figure 2: <b>LETLOB_CIBERSORT_PAM50_22062020_TGFbetasig.txt</b>, in .txt file format. Data supporting supplementary figure 3 and supplementary table 3: <b>LETLOB_Surv062020_PEPI.txt</b>, in .txt file format.