Title
Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative
Date Issued
27 April 2021
Access level
open access
Resource Type
review
Author(s)
Giorgi Rossi P.
Lebeau A.
Saz-Parkinson Z.
Quinn C.
Langendam M.
Mcgarrigle H.
Warman S.
Rigau D.
Alonso-Coello P.
Broeders M.
Graewingholt A.
Posso M.
Duffy S.
Schünemann H.J.
Autelitano M.
Borisch B.
Castells X.
Colzani E.
Daneš J.
Fitzpatrick P.
Giordano L.
Hofvind S.
Ioannidou-Mouzaka L.
Knox S.
Nystrom L.
Parmelli E.
Perez E.
Torresin A.
Van Engen R.
Van Landsveld-Verhoeven C.
Young K.
Biomedical Research Institute
Publisher(s)
Springer Nature
Abstract
Background: Predicting the risk of recurrence and response to chemotherapy in women with early breast cancer is crucial to optimise adjuvant treatment. Despite the common practice of using multigene tests to predict recurrence, existing recommendations are inconsistent. Our aim was to formulate healthcare recommendations for the question “Should multigene tests be used in women who have early invasive breast cancer, hormone receptor-positive, HER2-negative, to guide the use of adjuvant chemotherapy?” Methods: The European Commission Initiative on Breast Cancer (ECIBC) Guidelines Development Group (GDG), a multidisciplinary guideline panel including experts and three patients, developed recommendations informed by systematic reviews of the evidence. Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Four multigene tests were evaluated: the 21-gene recurrence score (21-RS), the 70-gene signature (70-GS), the PAM50 risk of recurrence score (PAM50-RORS), and the 12-gene molecular score (12-MS). Results: Five studies (2 marker-based design RCTs, two treatment interaction design RCTs and 1 pooled individual data analysis from observational studies) were included; no eligible studies on PAM50-RORS or 12-MS were identified and the GDG did not formulate recommendations for these tests. Conclusions: The ECIBC GDG suggests the use of the 21-RS for lymph node-negative women (conditional recommendation, very low certainty of evidence), recognising that benefits are probably larger in women at high risk of recurrence based on clinical characteristics. The ECIBC GDG suggests the use of the 70-GS for women at high clinical risk (conditional recommendation, low certainty of evidence), and recommends not using 70-GS in women at low clinical risk (strong recommendation, low certainty of evidence).
Start page
1503
End page
1512
Volume
124
Issue
9
Language
English
OCDE Knowledge area
Medicina clínica
Oncología
Scopus EID
2-s2.0-85101181473
PubMed ID
Source
British Journal of Cancer
ISSN of the container
00070920
Sponsor(s)
Funding information This work was supported by the European Commission. The E.C. did not have any role in the study design, collection, analysis and interpretation of the data. The researchers were independent of the funders and all authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.Dissemination declarationResults will be disseminated through the ECIBC webpage (https://healthcare-quality.jrc.ec.europa.eu/european-breast-cancer-guidelines) and specific women versions of these recommendations will also be made available to facilitate access to lay people.
Sources of information:
Directorio de Producción Científica
Scopus