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Breast cancer hormone receptor levels and benefit from adjuvant tamoxifen in a randomized trial with long-term follow-up

Fohlin, Helena ; Nordenskjöld, Anna ; Rosell, Johan ; Fernö, Mårten LU ; Fornander, Tommy ; Rydén, Lisa LU orcid ; Skoog, Lambert ; Nordenskjöld, Bo and Stål, Olle (2024) In Acta oncologica (Stockholm, Sweden) 63(1). p.535-541
Abstract

BACKGROUND: Hormone receptor positivity predicts benefit from endocrine therapy but the knowledge about the long-term survival of patients with different tumor receptor levels is limited. In this study, we describe the 25 years outcome of tamoxifen (TAM) treated patients.

PATIENTS AND METHODS: Between 1983 and 1992, a total of 4,610 postmenopausal patients with early-stage breast cancer were randomized to receive totally 2 or 5 years of TAM therapy. After 2 years, 4,124 were alive and free of breast cancer recurrence. Among these, 2,481 had demonstrated estrogen receptor positive (ER+) disease. From 1988, the Abbot enzyme immunoassay became available and provided quantitative receptor levels for 1,210 patients, for which our... (More)

BACKGROUND: Hormone receptor positivity predicts benefit from endocrine therapy but the knowledge about the long-term survival of patients with different tumor receptor levels is limited. In this study, we describe the 25 years outcome of tamoxifen (TAM) treated patients.

PATIENTS AND METHODS: Between 1983 and 1992, a total of 4,610 postmenopausal patients with early-stage breast cancer were randomized to receive totally 2 or 5 years of TAM therapy. After 2 years, 4,124 were alive and free of breast cancer recurrence. Among these, 2,481 had demonstrated estrogen receptor positive (ER+) disease. From 1988, the Abbot enzyme immunoassay became available and provided quantitative receptor levels for 1,210 patients, for which our analyses were done.

RESULTS: After 5 years of follow-up, when all TAM treatment was finished, until 15 years of follow-up, breast cancer mortality for patients with ER+ disease was significantly reduced in the 5-year group as compared with the 2-year group (hazard ratios [HR] 0.67, 95% confidence intervals [CI] 0.55-0.83, p < 0.001). After 15 years, the difference between the groups remained but did not increase further. A substantial benefit from prolonged TAM therapy was only observed for the subgroup of patients with ER levels below the median (HR = 0.62, 95% CI 0.46-0.84, p = 0.002). Similarly, patients with progesterone receptor negative (PR-) disease did benefit from prolonged TAM treatment. For patients with progesterone receptor positive (PR+) disease, there was no statistically significant benefit from more than 2 years of TAM. Interpretation: As compared with 2 years of adjuvant TAM, 5 years significantly prolonged breast cancer-specific survival. The benefit from prolonged TAM therapy was statistically significant for patients with ER levels below median or PR-negative disease. There was no evident benefit from prolonged TAM for patients with high ER levels or with PR+ tumors.

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; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Humans, Tamoxifen/therapeutic use, Breast Neoplasms/drug therapy, Female, Receptors, Estrogen/metabolism, Follow-Up Studies, Middle Aged, Antineoplastic Agents, Hormonal/therapeutic use, Receptors, Progesterone/metabolism, Chemotherapy, Adjuvant/methods, Aged, Postmenopause, Adult, Treatment Outcome
in
Acta oncologica (Stockholm, Sweden)
volume
63
issue
1
pages
535 - 541
publisher
Taylor & Francis
external identifiers
  • pmid:38967128
  • scopus:85197780234
ISSN
1651-226X
DOI
10.2340/1651-226X.2024.40493
language
English
LU publication?
yes
id
3318a408-a8ba-4f4c-bb0c-2a8c999bf016
date added to LUP
2024-11-18 10:43:44
date last changed
2025-07-15 23:44:02
@article{3318a408-a8ba-4f4c-bb0c-2a8c999bf016,
  abstract     = {{<p>BACKGROUND: Hormone receptor positivity predicts benefit from endocrine therapy but the knowledge about the long-term survival of patients with different tumor receptor levels is limited. In this study, we describe the 25 years outcome of tamoxifen (TAM) treated patients.</p><p>PATIENTS AND METHODS: Between 1983 and 1992, a total of 4,610 postmenopausal patients with early-stage breast cancer were randomized to receive totally 2 or 5 years of TAM therapy. After 2 years, 4,124 were alive and free of breast cancer recurrence. Among these, 2,481 had demonstrated estrogen receptor positive (ER+) disease. From 1988, the Abbot enzyme immunoassay became available and provided quantitative receptor levels for 1,210 patients, for which our analyses were done.</p><p>RESULTS: After 5 years of follow-up, when all TAM treatment was finished, until 15 years of follow-up, breast cancer mortality for patients with ER+ disease was significantly reduced in the 5-year group as compared with the 2-year group (hazard ratios [HR] 0.67, 95% confidence intervals [CI] 0.55-0.83, p &lt; 0.001). After 15 years, the difference between the groups remained but did not increase further. A substantial benefit from prolonged TAM therapy was only observed for the subgroup of patients with ER levels below the median (HR = 0.62, 95% CI 0.46-0.84, p = 0.002). Similarly, patients with progesterone receptor negative (PR-) disease did benefit from prolonged TAM treatment. For patients with progesterone receptor positive (PR+) disease, there was no statistically significant benefit from more than 2 years of TAM. Interpretation: As compared with 2 years of adjuvant TAM, 5 years significantly prolonged breast cancer-specific survival. The benefit from prolonged TAM therapy was statistically significant for patients with ER levels below median or PR-negative disease. There was no evident benefit from prolonged TAM for patients with high ER levels or with PR+ tumors.</p>}},
  author       = {{Fohlin, Helena and Nordenskjöld, Anna and Rosell, Johan and Fernö, Mårten and Fornander, Tommy and Rydén, Lisa and Skoog, Lambert and Nordenskjöld, Bo and Stål, Olle}},
  issn         = {{1651-226X}},
  keywords     = {{Humans; Tamoxifen/therapeutic use; Breast Neoplasms/drug therapy; Female; Receptors, Estrogen/metabolism; Follow-Up Studies; Middle Aged; Antineoplastic Agents, Hormonal/therapeutic use; Receptors, Progesterone/metabolism; Chemotherapy, Adjuvant/methods; Aged; Postmenopause; Adult; Treatment Outcome}},
  language     = {{eng}},
  month        = {{07}},
  number       = {{1}},
  pages        = {{535--541}},
  publisher    = {{Taylor & Francis}},
  series       = {{Acta oncologica (Stockholm, Sweden)}},
  title        = {{Breast cancer hormone receptor levels and benefit from adjuvant tamoxifen in a randomized trial with long-term follow-up}},
  url          = {{http://dx.doi.org/10.2340/1651-226X.2024.40493}},
  doi          = {{10.2340/1651-226X.2024.40493}},
  volume       = {{63}},
  year         = {{2024}},
}