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Use of tamoxifen before and during pregnancy

Geert Braems UGent, Hannelore Denys UGent, Olivier De Wever UGent, Veronique Cocquyt UGent and Rudy Van den Broecke UGent (2011) ONCOLOGIST. 16(11). p.1547-1551
abstract
For premenopausal patients with receptor-positive early breast cancer, administration of tamoxifen for 5 years constitutes the main adjuvant endocrine therapy. During pregnancy, tamoxifen and its metabolites interact with rapidly growing and developing embryonic or fetal tissues. Information about tamoxifen and pregnancy was gathered by searching PubMed. In addition, we had access to the records of the pharmaceutical company AstraZeneca. Because these observations are retrospective and other therapies and diagnostic measures are possible confounders, a causal relationship was not established between tamoxifen treatment and pregnancy outcome. The records from AstraZeneca documented three live births with congenital anomalies and four live births without congenital anomalies related to tamoxifen treatment before pregnancy. Tamoxifen therapy during pregnancy resulted in 16 live births with congenital malformations and a total of 122 live births without malformations. The 122 live births without malformations included 85 patients from a prevention trial that did not record a single anomaly, whereas the AstraZeneca Safety Database alone reported 11 babies with congenital malformations of 44 live births. Additionally, there were: 12 spontaneous abortions, 17 terminations of pregnancy without known fetal defects, six terminations of pregnancy with fetal defects, one stillbirth without fetal defects, two stillbirths with fetal defects, and 57 unknown outcomes. The relatively high frequency of severe congenital abnormalities indicates that reliable birth control during tamoxifen treatment is mandatory. After tamoxifen use, a washout period of 2 months is advisable based on the known half-life of tamoxifen. In case of an inadvertent pregnancy, risks and options should be discussed.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
BREAST-CANCER, WOMEN, THERAPY
journal title
ONCOLOGIST
Oncologist
volume
16
issue
11
pages
1547 - 1551
Web of Science type
Article
Web of Science id
000297860900009
JCR category
ONCOLOGY
JCR impact factor
3.91 (2011)
JCR rank
50/190 (2011)
JCR quartile
2 (2011)
ISSN
1083-7159
DOI
10.1634/theoncologist.2011-0121
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1980686
handle
http://hdl.handle.net/1854/LU-1980686
date created
2012-01-09 13:19:45
date last changed
2012-01-11 14:32:54
@article{1980686,
  abstract     = {For premenopausal patients with receptor-positive early breast cancer, administration of tamoxifen for 5 years constitutes the main adjuvant endocrine therapy. During pregnancy, tamoxifen and its metabolites interact with rapidly growing and developing embryonic or fetal tissues. 
Information about tamoxifen and pregnancy was gathered by searching PubMed. In addition, we had access to the records of the pharmaceutical company AstraZeneca. Because these observations are retrospective and other therapies and diagnostic measures are possible confounders, a causal relationship was not established between tamoxifen treatment and pregnancy outcome. 
The records from AstraZeneca documented three live births with congenital anomalies and four live births without congenital anomalies related to tamoxifen treatment before pregnancy. Tamoxifen therapy during pregnancy resulted in 16 live births with congenital malformations and a total of 122 live births without malformations. The 122 live births without malformations included 85 patients from a prevention trial that did not record a single anomaly, whereas the AstraZeneca Safety Database alone reported 11 babies with congenital malformations of 44 live births. Additionally, there were: 12 spontaneous abortions, 17 terminations of pregnancy without known fetal defects, six terminations of pregnancy with fetal defects, one stillbirth without fetal defects, two stillbirths with fetal defects, and 57 unknown outcomes. 
The relatively high frequency of severe congenital abnormalities indicates that reliable birth control during tamoxifen treatment is mandatory. After tamoxifen use, a washout period of 2 months is advisable based on the known half-life of tamoxifen. In case of an inadvertent pregnancy, risks and options should be discussed.},
  author       = {Braems, Geert and Denys, Hannelore and De Wever, Olivier and Cocquyt, Veronique and Van den Broecke, Rudy},
  issn         = {1083-7159},
  journal      = {ONCOLOGIST},
  keyword      = {BREAST-CANCER,WOMEN,THERAPY},
  language     = {eng},
  number       = {11},
  pages        = {1547--1551},
  title        = {Use of tamoxifen before and during pregnancy},
  url          = {http://dx.doi.org/10.1634/theoncologist.2011-0121},
  volume       = {16},
  year         = {2011},
}

Chicago
Braems, Geert, Hannelore Denys, Olivier De Wever, Veronique Cocquyt, and Rudy Van den Broecke. 2011. “Use of Tamoxifen Before and During Pregnancy.” Oncologist 16 (11): 1547–1551.
APA
Braems, G., Denys, H., De Wever, O., Cocquyt, V., & Van den Broecke, R. (2011). Use of tamoxifen before and during pregnancy. ONCOLOGIST, 16(11), 1547–1551.
Vancouver
1.
Braems G, Denys H, De Wever O, Cocquyt V, Van den Broecke R. Use of tamoxifen before and during pregnancy. ONCOLOGIST. 2011;16(11):1547–51.
MLA
Braems, Geert, Hannelore Denys, Olivier De Wever, et al. “Use of Tamoxifen Before and During Pregnancy.” ONCOLOGIST 16.11 (2011): 1547–1551. Print.