Meta-analysisBreast cancer

20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years

N Engl J Med · 201762,923 women
Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, et al. N Engl J Med. 2017. 377:1836-1846
Study type
Meta-analysis
Study name
EBCTCG
Design
Meta-analysis of the results of 88 trials (Kaplan–Meier and Cox regression analyses, stratified by trial and treatment)
Sample size
62,923 women
Source
N Engl J Med · 2017

In plain words

This large study showed that women who have had hormone-sensitive breast cancer and took hormone therapy for 5 years remain at risk of the cancer coming back at a steady rate for up to 20 years afterwards. The size of this risk depends on the size of the tumour and the number of lymph nodes involved at diagnosis, and ranges from 10% to 41%. This information helps you and your doctor make better decisions about continuing hormone therapy.

Key results

13%
Risk of distant recurrence, T1N0
Years 5 to 20
20%
Risk of distant recurrence, T1N1-3
34%
Risk of distant recurrence, T1N4-9
19%
Risk of distant recurrence, T2N0
26%
Risk of distant recurrence, T2N1-3
41%
Risk of distant recurrence, T2N4-9
10%, 13% and 17%
Absolute risk of distant recurrence in T1N0 by tumour grade (low, intermediate, high)
17%, 22% and 26%
Risk of any recurrence or contralateral breast cancer in T1N0 by tumour grade (low, intermediate, high)

Treatment arms and regimens

1All patients (endocrine therapy stopped at year 5)

5 years of scheduled endocrine therapy; then follow-up from year 5 to 20.

Meta-analysis of multiple trials; dose and schedule varied between trials and no single dose is reported.

Source of the regimen details: Abstract of the paper

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Women with ER-positive breast cancer who were disease-free after 5 years of scheduled endocrine therapy.

Endpoints

Assessment of the association of tumour diameter and nodal status (TN), tumour grade and other factors with patient outcomes from year 5 to 20 (distant recurrence, breast cancer death, contralateral breast cancer).

Safety and side effects

This study is a meta-analysis of recurrence outcomes, and treatment adverse event data are not reported in the abstract.

Clinical significance and place in guidelines

This meta-analysis provides absolute estimates of the risk of distant recurrence after stopping endocrine therapy at year 5 by TN status and tumour grade, and can help in decisions about extending endocrine therapy (taking the additional adverse effects into account). Progesterone receptor and HER2 status were not predictive. The status of adoption in clinical guidelines should be checked separately.

Limitations

Tumour grade data were available for only 43,590 patients, Ki-67 for 7692 patients and HER2 for 15,418 patients (in trials without trastuzumab). Other limitations should be checked in the full text.

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.