uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials
2011 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 378, 771-784 p.Article in journal (Refereed) Published
Abstract [en]

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=21457) 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.

Place, publisher, year, edition, pages
2011. Vol. 378, 771-784 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-206213DOI: 10.1016/S0140- 6736(11)60993-8ISI: 000294585300033OAI: oai:DiVA.org:uu-206213DiVA: diva2:644102

Lars Holmberg, Uppsala University, is a member of this collaboration.  A full list of collaborators is listed at the end of this article.

Available from: 2013-08-29 Created: 2013-08-29 Last updated: 2013-08-29Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textLink to EBCTCG

Search in DiVA

By author/editor
Early Breast Cancer Trialists’ Collaborative Group, EBCTCG
In the same journal
The Lancet
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar

Altmetric score

Total: 190 hits
ReferencesLink to record
Permanent link

Direct link