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Cited by 3,075Breast Cancer Treatment StudiesEstrogen and related hormone effectsEndometrial and Cervical Cancer Treatments

Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials

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Early Breast Cancer Trialists' Collaborative Group (EBCTCG)·2011·The Lancet
DOI 10.1016/s0140-6736(11)60993-8PMC PMC3163848
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Abstract

Background As trials of 5 years of tamoxifen in early breast cancer mature, the relevance of hormone receptor measurements (and other patient characteristics) to long-term outcome can be assessed increasingly reliably. We report updated meta-analyses of the trials of 5 years of adjuvant tamoxifen.Methods We undertook a collaborative meta-analysis of individual patient data from 20 trials (n=21,457) in early breast cancer of about 5 years of tamoxifen versus no adjuvant tamoxifen, with about 80% compliance. Recurrence and death rate ratios (RRs) were from log-rank analyses by allocated treatment.Findings In oestrogen receptor (ER)-positive disease (n=10,645), allocation to about 5 years of tamoxifen substantially reduced recurrence rates throughout the first 10 years (RR 0·53 [SE 0·03] during years 0-4 and RR 0·68 [0·06] during years 5-9 [both 2p<0·00001]; but RR 0·97 [0·10] during years 10-14, suggesting no further gain or loss after year 10). Even in marginally ER-positive disease (10-19 fmol/mg cytosol protein) the recurrence reduction was substantial (RR 0·67 [0·08]). In ER-positive disease, the RR was approximately independent of progesterone receptor status (or level), age, nodal status, or use of chemotherapy. Breast cancer mortality was reduced by about a third throughout the first 15 years (RR 0·71 [0·05] during years 0-4, 0·66 [0·05] during years 5-9, and 0·68 [0·08] during years 10-14; p<0·0001 for extra mortality reduction during each separate time period). Overall non-breast-cancer mortality was little affected, despite small absolute increases in thromboembolic and uterine cancer mortality (both only in women older than 55 years), so all-cause mortality was substantially reduced. In ER-negative disease, tamoxifen had little or no effect on breast cancer recurrence or mortality.Interpretation 5 years of adjuvant tamoxifen safely reduces 15-year risks of breast cancer recurrence and death. ER status was the only recorded factor importantly predictive of the proportional reductions. Hence, the absolute risk reductions produced by tamoxifen depend on the absolute breast cancer risks (after any chemotherapy) without tamoxifen.Funding Cancer Research UK, British Heart Foundation, and Medical Research Council.

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  1. [18]Ayme Y, Spitalier JM, Amalric R, et al. Preliminary results of a three-arm randomized trial of adjuvant chemo- and/or hormone-therapy for high-risk breast cancer. Fourth EORTC breast cancer working conference 1987; June 30–July 3, 1987; Imperial College, London, UK; C2A.1.
  2. [19]Martin PM Romain S Spyratos F Reevaluation of the indications of adjuvant hormonotherapy in high risk primary breast cancer patients Bull Cancer 78 1991 709 723 1932838

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Authors
Early Breast Cancer Trialists' Collaborative Group (EBCTCG)
Affiliations
University of Oxford (GB)
Corresponding author
Early Breast Cancer Trialists' Collaborative Group (EBCTCG)
Venue
The Lancet
Publisher
Elsevier BV
Published
2011-08
Volume
378
Issue
9793
Pages
771-784
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(11)60993-8
PMC
PMC3163848
OpenAlex
W2118728607
Cited by
3,075
References
34
Citations by year
2026: 123 · 2025: 175 · 2024: 187 · 2023: 226 · 2022: 233 · 2021: 246 · 2020: 272 · 2019: 189 · 2018: 232 · 2017: 216 · 2016: 239 · 2015: 226 · 2014: 188 · 2013: 177 · 2012: 122
FWCI
11.82
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Research Publications (Maastricht University) (publishedVersion, other-oa)
  • Research Portal (King's College London) (publishedVersion)
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  • University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
  • ResearchOnline (Glasgow Caledonian University) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
  • ArTS Archivio della ricerca di Trieste (University of Trieste https://www.units.it/) (submittedVersion)
  • Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
  • The HKU Scholars Hub (University of Hong Kong) (submittedVersion)
  • CINECA IRIS Institutial Research Information System (University of Genoa) (submittedVersion)
  • Lund University Publications (Lund University) (submittedVersion)
  • Research Portal (Queen's University Belfast) (submittedVersion)
  • ResearchOnline (submittedVersion)
  • Research Publications (Maastricht University) (submittedVersion)
Funders
  • AstraZeneca
  • Cancer Research UK (10588)
  • British Heart Foundation
  • University of Oxford
  • Tel Aviv University
  • Tays
  • Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung
  • Medical Research Council
  • National Cancer Institute (P30CA008748)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
  • Health Sciences › Medicine › Obstetrics and Gynecology › Endometrial and Cervical Cancer Treatments
Keywords
early breast cancer, oestrogen receptor, progesterone receptor, breast cancer recurrence, breast cancer mortality, long-term survival, estrogen receptor-negative breast cancer, thromboembolic events, uterine cancer, prognostic factors, lymph node status, age
MeSH terms
Breast Neoplasms, Female, Humans, Neoplasm Recurrence, Local, Receptors, Estrogen, Receptors, Progesterone, Tamoxifen, Randomized Controlled Trials as Topic, Neoplasms, Second Primary, Chemotherapy, Adjuvant, Antineoplastic Agents, Hormonal, Selective Estrogen Receptor Modulators

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