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
ECIBC (European Commission) · 2021 · Europe
Source and licence
- Authors
- Paolo Giorgi Rossi, Annette Lebeau, Carlos Canelo-Aybar et al.
- 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
- Journal
- British Journal of Cancer, 2021
- Licence
- CC BY 4.0
- Changes
- Verbatim excerpts; formatting adapted
Full text retrieved 2026-10-27 from Europe PMC · PMC8076250
Licence statement of the original publication
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Recommendations
Verbatim, with grade of recommendation or strength of consensus where given.
Unanswered questions and future research
- The GDG recommends research on exploring in what subgroups the use of 21-RS would have larger anticipated benefits as well as carrying out longer follow-up studies for 70-GS. The recommendations will be updated according to the ECIBC monitoring strategy in placehttps://healthcare-quality.jrc.ec.europa.eu/discover-ecibc/methodologies/guidelines-updating
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).
Contents of the original publication
The section headings of the original.
- Background
- Methods
- Structured question and outcome prioritisation
- Systematic review
- Comparison scenarios and modelling
- Evidence to decision and recommendation formulation
- Results
- Included studies
- 21 gene recurrence score
- 70-GS
- Modelling for predicting impact of testing on patient’s outcomes
- Results from the systematic review of economic evidence
- Certainty of evidence
- Evidence to decision frameworks
- Discussion
- Statement of principal findings
- Strengths and weaknesses of the study
- Relation to other guidelines
- Meaning of the study
- Unanswered questions and future research
- Consent to publish
- Dissemination declaration
- Contributor Information
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