TY - JOUR
T1 - 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
AU - the ECIBC Contributor Group
AU - Giorgi Rossi, Paolo
AU - Lebeau, Annette
AU - Canelo-Aybar, Carlos
AU - Saz-Parkinson, Zuleika
AU - Quinn, Cecily
AU - Langendam, Miranda
AU - Mcgarrigle, Helen
AU - Warman, Sue
AU - Rigau, David
AU - Alonso-Coello, Pablo
AU - Broeders, Mireille
AU - Graewingholt, Axel
AU - Posso, Margarita
AU - Duffy, Stephen
AU - Schünemann, Holger J.
AU - Autelitano, Mariangela
AU - Borisch, Bettina
AU - Castells, Xavier
AU - Colzani, Edoardo
AU - Daneš, Jan
AU - Fitzpatrick, Patricia
AU - Giordano, Livia
AU - Hofvind, Solveig
AU - Ioannidou-Mouzaka, Lydia
AU - Knox, Susan
AU - Nystrom, Lennarth
AU - Parmelli, Elena
AU - Perez, Elsa
AU - Torresin, Alberto
AU - Van Engen, Ruben
AU - Van Landsveld-Verhoeven, Cary
AU - Young, Ken
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/4/27
Y1 - 2021/4/27
N2 - 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).
AB - 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).
UR - https://www.scopus.com/pages/publications/85101181473
U2 - 10.1038/s41416-020-01247-z
DO - 10.1038/s41416-020-01247-z
M3 - Review article
C2 - 33597715
AN - SCOPUS:85101181473
SN - 0007-0920
VL - 124
SP - 1503
EP - 1512
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 9
ER -