Tamoxifen related side effects and their impact on breast cancer incidence: A retrospective analysis of the randomised IBIS-I trial.
Antineoplastic Agents, Hormonal
/ adverse effects
Breast Neoplasms
/ chemically induced
Drug-Related Side Effects and Adverse Reactions
/ complications
Female
Follow-Up Studies
Hot Flashes
/ chemically induced
Humans
Incidence
Middle Aged
Postmenopause
Proportional Hazards Models
Randomized Controlled Trials as Topic
Receptors, Estrogen
/ metabolism
Retrospective Studies
Tamoxifen
/ adverse effects
Treatment Outcome
Vaginal Discharge
/ chemically induced
Vaginal Diseases
/ chemically induced
Breast cancer
Gynaecological symptoms
Hot flushes
Prevention
Tamoxifen
Journal
Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
20
10
2020
accepted:
29
10
2020
pubmed:
8
11
2020
medline:
12
8
2021
entrez:
7
11
2020
Statut:
ppublish
Résumé
Studies in the adjuvant setting have shown that endocrine therapy related side effects predict breast cancer recurrence risk. Here, we assess the relationship between early reported side effects and incidence of breast cancer in women randomised to tamoxifen for cancer prevention in the International Breast Intervention Study (IBIS)-I trial. Women randomised to tamoxifen in the IBIS-I trial and for whom side effect status was known at the 6-month follow-up visit were included in this analysis. Side effects included in this analysis were hot flushes, vaginal discharge, and vaginal dryness. The primary endpoint was all breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer. Cox proportional hazard models were used to investigate breast cancer incidence in the tamoxifen group with and without side effects reported within 6 months of randomisation. Women randomised to tamoxifen and reporting hot flushes at the 6-month follow-up visit had a non-statistically significant increase in breast cancer compared to those without hot flushes (HR = 1.26 (0.98-1.62), P = 0.08). A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01). A higher risk was observed for ER-positive breast cancer in postmenopausal women (HR = 1.81 (1.19-2.74), P = 0.01). No significant associations between gynaecological side effects and breast cancer occurrence was observed. Overall, no association between side effects reported at 6 months and subsequent breast cancer occurrence was observed. Some side effects might be useful markers for breast cancer occurrence in postmenopausal women.
Sections du résumé
BACKGROUND
BACKGROUND
Studies in the adjuvant setting have shown that endocrine therapy related side effects predict breast cancer recurrence risk. Here, we assess the relationship between early reported side effects and incidence of breast cancer in women randomised to tamoxifen for cancer prevention in the International Breast Intervention Study (IBIS)-I trial.
METHODS
METHODS
Women randomised to tamoxifen in the IBIS-I trial and for whom side effect status was known at the 6-month follow-up visit were included in this analysis. Side effects included in this analysis were hot flushes, vaginal discharge, and vaginal dryness. The primary endpoint was all breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer. Cox proportional hazard models were used to investigate breast cancer incidence in the tamoxifen group with and without side effects reported within 6 months of randomisation.
RESULTS
RESULTS
Women randomised to tamoxifen and reporting hot flushes at the 6-month follow-up visit had a non-statistically significant increase in breast cancer compared to those without hot flushes (HR = 1.26 (0.98-1.62), P = 0.08). A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01). A higher risk was observed for ER-positive breast cancer in postmenopausal women (HR = 1.81 (1.19-2.74), P = 0.01). No significant associations between gynaecological side effects and breast cancer occurrence was observed.
CONCLUSIONS
CONCLUSIONS
Overall, no association between side effects reported at 6 months and subsequent breast cancer occurrence was observed. Some side effects might be useful markers for breast cancer occurrence in postmenopausal women.
Identifiants
pubmed: 33160147
pii: S0960-9776(20)30206-X
doi: 10.1016/j.breast.2020.10.015
pmc: PMC7649356
pii:
doi:
Substances chimiques
Antineoplastic Agents, Hormonal
0
Receptors, Estrogen
0
Tamoxifen
094ZI81Y45
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
216-221Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest JC has received research grants from AstraZeneca, all other authors declare no conflict of interest.
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