Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis.
Adult
Aged
Antineoplastic Agents, Immunological
/ therapeutic use
Breast Neoplasms
/ drug therapy
Chemotherapy, Adjuvant
/ methods
Disease-Free Survival
Equivalence Trials as Topic
Female
Humans
Middle Aged
Randomized Controlled Trials as Topic
Receptor, ErbB-2
/ metabolism
Time Factors
Trastuzumab
/ therapeutic use
Treatment Outcome
Adjuvant
Breast
HER2
Trastuzumab
Journal
Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
11
03
2020
revised:
07
10
2020
accepted:
12
10
2020
pubmed:
2
11
2020
medline:
12
8
2021
entrez:
1
11
2020
Statut:
ppublish
Résumé
One year of adjuvant trastuzumab is considered the standard treatment for patients with HER2 positive breast cancer. However, a shorter duration of trastuzumab may be associated with reduced costs and side effects. Results from randomized trials with diverse non-inferiority margins comparing one year to a shorter duration of adjuvant trastuzumab are not consistent and have not been systematically reviewed using a non-inferiority meta-analysis approach. We conducted a systematic review and meta-analysis of randomized trials to assess whether a shorter duration of adjuvant trastuzumab was non-inferior to one year of treatment or not. The non-inferiority margin for the meta-analysis was pre-defined as the median of the margins of all the trials included. Data of 11,376 patients from 5 trials were analyzed. Non-inferiority margins in included studies varied from 1.15 to 1.53 with median of 1.29 for HR of DFS. A shorter duration of trastuzumab was non-inferior to one year of therapy for DFS (HR 1.13, 95%CI 1.03-1.24) but inconclusive for OS (HR 1.14, 95%CI 1.00-1.30). In a subgroup analysis for DFS outcome, shorter therapy was non-inferior in patients with ER positive disease (HR 1.10, 95%CI 0.95-1.28) and those with sequential therapy (HR 0.97, 95%CI 0.75-1.27) and when the duration of treatment was 6 months (HR 1.09, 95%CI 0.98-1.22). Although a shorter duration of adjuvant trastuzumab was non-inferior to one year of therapy for DFS in patients with HER2 positive breast cancer based on our HR margin of 1.29, any benefit of a shorter duration comes at a loss of efficacy with an increase in absolute risk up to 3.9% for 5 year DFS. Whether the potential increased risk is clinically acceptable for the benefits of a shorter duration remains debatable.
Identifiants
pubmed: 33130486
pii: S0960-9776(20)30194-6
doi: 10.1016/j.breast.2020.10.003
pmc: PMC7599130
pii:
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
Receptor, ErbB-2
EC 2.7.10.1
Trastuzumab
P188ANX8CK
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
203-210Informations de copyright
Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Author RF has accepted honoraria from Bayer, Pzifer, BMS and Novartis as well as travel grant from Janssen. JR has accepted honorarium and was on advisory board for Roche and Lilly.
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