T N Schuurman1, P O Witteveen2, E van der Wall2, J L M Passier3, A D R Huitema4,5, F Amant1,6,7, C A R Lok8. 1. Department of Gynecologic Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. 2. Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands. 3. Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands. 4. Department of Pharmacy & Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, The Netherlands. 5. Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. 6. Department of Gynecologic Oncology, Amsterdam University Medical Center, Amsterdam, The Netherlands. 7. Department of Oncology, Catholic University of Leuven, Leuven, Belgium. 8. Department of Gynecologic Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. c.lok@nki.nl.
Abstract
PURPOSE: Breast cancer is the most common malignancy among young women of reproductive age. Adjuvant treatment with tamoxifen reduces the risk of recurrence in hormone-sensitive breast cancer. However, the use of tamoxifen is considered contraindicated during pregnancy, because of a limited number of case reports demonstrating potential adverse effects on the fetus. The objective of this report is to give a more broad overview of the available data on the effect of tamoxifen exposure during pregnancy. METHODS: A literature review was performed using PubMed and the databases of the Netherlands Pharmacovigilance Centre Lareb and of the International Network on Cancer, Infertility, and Pregnancy. RESULTS: A total of 238 cases of tamoxifen use during pregnancy were found. Of the 167 pregnancies with known outcome, 21 were complicated by an abnormal fetal development. The malformations described were non-specific and the majority of cases concerned healthy infants despite exposure to tamoxifen. CONCLUSION: There seems to be an increased risk of fetal abnormalities when taking tamoxifen during pregnancy (12.6% in contrast to 3.9% in the general population), but the evidence is limited and no causal relationship could be established. The possible disadvantage of postponing or discontinuing tamoxifen for the maternal prognosis is unclear. Patients should be counseled about the use of tamoxifen during pregnancy instead of presenting it as being absolutely contraindicated.
PURPOSE:Breast cancer is the most common malignancy among young women of reproductive age. Adjuvant treatment with tamoxifen reduces the risk of recurrence in hormone-sensitive breast cancer. However, the use of tamoxifen is considered contraindicated during pregnancy, because of a limited number of case reports demonstrating potential adverse effects on the fetus. The objective of this report is to give a more broad overview of the available data on the effect of tamoxifen exposure during pregnancy. METHODS: A literature review was performed using PubMed and the databases of the Netherlands Pharmacovigilance Centre Lareb and of the International Network on Cancer, Infertility, and Pregnancy. RESULTS: A total of 238 cases of tamoxifen use during pregnancy were found. Of the 167 pregnancies with known outcome, 21 were complicated by an abnormal fetal development. The malformations described were non-specific and the majority of cases concerned healthy infants despite exposure to tamoxifen. CONCLUSION: There seems to be an increased risk of fetal abnormalities when taking tamoxifen during pregnancy (12.6% in contrast to 3.9% in the general population), but the evidence is limited and no causal relationship could be established. The possible disadvantage of postponing or discontinuing tamoxifen for the maternal prognosis is unclear. Patients should be counseled about the use of tamoxifen during pregnancy instead of presenting it as being absolutely contraindicated.
Entities:
Keywords:
Breast cancer; Fetal toxicity; Pregnancy; Tamoxifen; Teratogenicity
Authors: Fedro Alessandro Peccatori; Giovanni Codacci-Pisanelli; Gunnar Mellgren; Barbara Buonomo; Eleonora Baldassarre; Ernst Asbjorn Lien; Ersilia Bifulco; Steinar Hustad; Emil Zachariassen; Harriet Johansson; Thomas Helland Journal: ESMO Open Date: 2020-10