Tamoxifen and pregnancy: an absolute contraindication?

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.

Systematic lymphadenectomy in patients with clinical stage II endometrial carcinoma: a case report and review of the literature.

OBJECTIVE: The aim of this case report and review of the literature was to evaluate the effect of adding pelvic and/or para-aortic lymphadenectomy to hysterectomy and bilateral salpingo-oophorectomy (BSO) on the five year recurrence-free survival in patients with clinical Stage II endometrial carcinoma. MATERIALS AND METHODS: A Pubmed, Embase, and Cochrane library search was performed to identify relevant articles. After screening, using predetermined exclusion and inclusion criteria, and critical appraisal, a final of four articles remained. RESULTS: This search only revealed studies with a retrospective design. Two articles showed a significant disease-specific survival benefit in patients undergoing systematic lymphadenectomy for Stage II endometrial carcinoma. In multivariate analyses, conducted in both studies, this improvement in survival was also evident (HR 0.75, 95% CI 0.69 - 0.81, p < 0.001 and HR 0.74, 95% CI 0.58 - 0.93, p = 0.0096). The remaining studies revealed a non-significant ten-year recurrence-free survival (77% vs 65%) and five-year overall survival (72% vs 70%) in favour of patients undergoing systematic lymphadenectomy. CONCLUSION: The practise of performing a systematic lymphadenectomy in patients with clinical Stage II endometrial carcinoma as advocated in guidelines, is not based on evidence from randomised clinical trials. However, lymph node dissection seems to improve the five-year disease-specific survival in retrospective studies.