Department of Gynecologic Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands.
Breast Cancer Res Treat. 2019 May;175(1):17-25. doi: 10.1007/s10549-019-05154-7. Epub 2019 Feb 1.
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.
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.
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.
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.
乳腺癌是生育期年轻女性最常见的恶性肿瘤。辅助应用他莫昔芬可降低激素敏感性乳腺癌的复发风险。然而，由于少数病例报告显示其对胎儿可能存在潜在的不良影响，故他莫昔芬在孕期的应用被认为是禁忌。本报告的目的是更全面地概述孕期暴露于他莫昔芬的相关数据。
检索 PubMed 及荷兰药物警戒中心 Lareb 和国际癌症、不孕不育与妊娠网络数据库，进行文献回顾。
共发现 238 例孕期应用他莫昔芬的病例。在 167 例已知结局的妊娠中，21 例出现胎儿发育异常。所描述的畸形并不特异，且大多数病例尽管暴露于他莫昔芬，仍为健康婴儿。
孕期应用他莫昔芬似乎会增加胎儿畸形的风险（12.6%，而普通人群为 3.9%），但证据有限，且无法建立因果关系。推迟或停止他莫昔芬治疗对母体预后的可能不利影响尚不清楚。应告知患者孕期应用他莫昔芬的风险，而不是将其描述为绝对禁忌。
