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Side effects of low...
Side effects of low-dose tamoxifen : results from a six-armed randomised controlled trial in healthy women
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- Hammarström, Mattias (author)
- Karolinska Institutet,Karolinska Institute
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- Gabrielson, Marike (author)
- Karolinska Institutet,Karolinska Institute
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- Crippa, Alessio (author)
- Karolinska Institutet,Karolinska Institute
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- Discacciati, Andrea (author)
- Karolinska Institutet,Karolinska Institute
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- Eklund, Martin (author)
- Karolinska Institutet,Karolinska Institute
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- Lundholm, Cecilia (author)
- Karolinska Institutet,Karolinska Institute
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- Bäcklund, Magnus (author)
- Karolinska Institutet,Karolinska Institute
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- Wengström, Yvonne (author)
- Karolinska Institutet,Karolinska University Hospital
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- Borgquist, Signe (author)
- Lund University,Lunds universitet,Bröstcancer - prevention & intervention,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Bröstcancer,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Breast cancer prevention & intervention,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Breastcancer,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Aarhus University Hospital
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- Bergqvist, Jenny (author)
- Karolinska Institutet,Karolinska Institute,Capio St. Görans Sjukhus
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- Eriksson, Mikael (author)
- Karolinska Institutet,Karolinska Institute
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- Tapia, José (author)
- Karolinska Institute
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- Czene, Kamila (author)
- Karolinska Institutet,Karolinska Institute
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- Hall, Per (author)
- Karolinska Institutet,Karolinska Institute,Stockholm South General Hospital
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(creator_code:org_t)
- 2023
- 2023
- English 11 s.
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In: British Journal of Cancer. - 0007-0920 .- 1532-1827. ; 129:1, s. 61-71
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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- ref (subject category)
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- By the author/editor
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Hammarström, Mat ...
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Gabrielson, Mari ...
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Crippa, Alessio
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Discacciati, And ...
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Eklund, Martin
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Lundholm, Cecili ...
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show more...
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Bäcklund, Magnus
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Wengström, Yvonn ...
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Borgquist, Signe
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Bergqvist, Jenny
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Eriksson, Mikael
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Tapia, José
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Czene, Kamila
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Hall, Per
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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British Journal ...
- By the university
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Lund University
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Karolinska Institutet