Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Side effects of low-dose tamoxifen : results from a six-armed randomised controlled trial in healthy women

Hammarström, Mattias ; Gabrielson, Marike ; Crippa, Alessio ; Discacciati, Andrea ; Eklund, Martin ; Lundholm, Cecilia ; Bäcklund, Magnus ; Wengström, Yvonne ; Borgquist, Signe LU and Bergqvist, Jenny , et al. (2023) In British Journal of Cancer 129(1). p.61-71
Abstract

Background: Adherence to adjuvant tamoxifen therapy is suboptimal, and acceptance of tamoxifen for primary prevention is poor. Published results indicate effect of low-dose tamoxifen therapy. Using questionnaire data from a randomised controlled trial, we describe side effects of standard and low-dose tamoxifen in healthy women. Methods: In the KARISMA trial, 1440 healthy women were randomised to 6 months of daily intake of 20, 10, 5, 2.5, 1 mg of tamoxifen or placebo. Participants completed a 48-item, five-graded Likert score symptom questionnaire at baseline and follow-up. Linear regression models were used to identify significant changes in severity levels across doses and by menopausal status. Results: Out of 48 predefined symptoms,... (More)

Background: Adherence to adjuvant tamoxifen therapy is suboptimal, and acceptance of tamoxifen for primary prevention is poor. Published results indicate effect of low-dose tamoxifen therapy. Using questionnaire data from a randomised controlled trial, we describe side effects of standard and low-dose tamoxifen in healthy women. Methods: In the KARISMA trial, 1440 healthy women were randomised to 6 months of daily intake of 20, 10, 5, 2.5, 1 mg of tamoxifen or placebo. Participants completed a 48-item, five-graded Likert score symptom questionnaire at baseline and follow-up. Linear regression models were used to identify significant changes in severity levels across doses and by menopausal status. Results: Out of 48 predefined symptoms, five were associated with tamoxifen exposure (hot flashes, night sweats, cold sweats, vaginal discharge and muscle cramps). When comparing these side effects in premenopausal women randomised to low doses (2.5, 5 mg) versus high doses (10, 20 mg), the mean change was 34% lower in the low-dose group. No dose-dependent difference was seen in postmenopausal women. Conclusions: Symptoms related to tamoxifen therapy are influenced by menopausal status. Low-dose tamoxifen, in contrast to high-dose, was associated with less pronounced side effects, a finding restricted to premenopausal women. Our findings give new insights which may influence future dosing strategies of tamoxifen in both the adjuvant and preventive settings. Trial registration: ClinicalTrials.gov ID: NCT03346200.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
British Journal of Cancer
volume
129
issue
1
pages
11 pages
publisher
Nature Publishing Group
external identifiers
  • scopus:85158111717
  • pmid:37149701
ISSN
0007-0920
DOI
10.1038/s41416-023-02293-z
language
English
LU publication?
yes
id
d6316ab1-a23d-44e3-a788-5cd21f81dc40
date added to LUP
2023-08-16 09:10:25
date last changed
2024-06-15 05:53:41
@article{d6316ab1-a23d-44e3-a788-5cd21f81dc40,
  abstract     = {{<p>Background: Adherence to adjuvant tamoxifen therapy is suboptimal, and acceptance of tamoxifen for primary prevention is poor. Published results indicate effect of low-dose tamoxifen therapy. Using questionnaire data from a randomised controlled trial, we describe side effects of standard and low-dose tamoxifen in healthy women. Methods: In the KARISMA trial, 1440 healthy women were randomised to 6 months of daily intake of 20, 10, 5, 2.5, 1 mg of tamoxifen or placebo. Participants completed a 48-item, five-graded Likert score symptom questionnaire at baseline and follow-up. Linear regression models were used to identify significant changes in severity levels across doses and by menopausal status. Results: Out of 48 predefined symptoms, five were associated with tamoxifen exposure (hot flashes, night sweats, cold sweats, vaginal discharge and muscle cramps). When comparing these side effects in premenopausal women randomised to low doses (2.5, 5 mg) versus high doses (10, 20 mg), the mean change was 34% lower in the low-dose group. No dose-dependent difference was seen in postmenopausal women. Conclusions: Symptoms related to tamoxifen therapy are influenced by menopausal status. Low-dose tamoxifen, in contrast to high-dose, was associated with less pronounced side effects, a finding restricted to premenopausal women. Our findings give new insights which may influence future dosing strategies of tamoxifen in both the adjuvant and preventive settings. Trial registration: ClinicalTrials.gov ID: NCT03346200.</p>}},
  author       = {{Hammarström, Mattias and Gabrielson, Marike and Crippa, Alessio and Discacciati, Andrea and Eklund, Martin and Lundholm, Cecilia and Bäcklund, Magnus and Wengström, Yvonne and Borgquist, Signe and Bergqvist, Jenny and Eriksson, Mikael and Tapia, José and Czene, Kamila and Hall, Per}},
  issn         = {{0007-0920}},
  language     = {{eng}},
  month        = {{07}},
  number       = {{1}},
  pages        = {{61--71}},
  publisher    = {{Nature Publishing Group}},
  series       = {{British Journal of Cancer}},
  title        = {{Side effects of low-dose tamoxifen : results from a six-armed randomised controlled trial in healthy women}},
  url          = {{http://dx.doi.org/10.1038/s41416-023-02293-z}},
  doi          = {{10.1038/s41416-023-02293-z}},
  volume       = {{129}},
  year         = {{2023}},
}