Pregnancy outcomes in women exposed to cancer chemotherapy

Pharmacoepidemiol Drug Saf. 2018 Dec;27(12):1302-1308. doi: 10.1002/pds.4689. Epub 2018 Oct 31.


Purpose: There is little data on the effects of cancer chemotherapy in pregnant women. The objective of this study was to describe pregnancy outcomes of women exposed to cancer chemotherapy, recorded in the French Terappel database.

Methods: We performed a descriptive, prospective study of the pregnancies of women exposed to cancer chemotherapy recorded in Terappel between June 1984 and December 2016. Terappel is a French database that has recorded questions of health professionals and/or individuals at the Regional Pharmacovigilance Centres about drugs and pregnancy. For each question, pregnancies are monitored and the outcome is recorded in the database.

Results: In total, 75 questions about "anti-cancer drugs and pregnancy" received by 16 Regional Pharmacovigilance Centres between 1997 and 2016 were recorded in Terappel. Breast cancer accounted for 62.7% of the cases, followed by leukaemia (13.3%) and lymphoma (9.3%). Cyclophosphamide is the leading anti-cancer drug with 40.0% of exposed pregnant women, followed by 5-fluorouracil (34.7%), epirubicin (32.0%), tamoxifen (26.7%), and doxorubicin (16.0%). Among the 75 pregnancies, we observed 55 births with 57 children (73.3%) (two cases of twins), nine medical terminations of pregnancy (12.0%), six voluntary terminations of pregnancy (8.0%), three intrauterine foetal deaths (4.0%), and two miscarriages (2.7%). We found a malformation rate of 7.8%. Sixteen of 57 (28.1%) newborns developed one or more neonatal pathologies.

Conclusion: Pregnancy of women taking anti-cancer drugs resulted in birth in 73% of cases. Nevertheless, pregnant women exposed to cancer chemotherapy remains at risk of malformations and neonatal conditions related to prematurity and drugs.

Keywords: cancer; chemotherapy; malformation; neonatal pathology; pharmacoepidemiology; pregnancy.

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology*
  • Abnormalities, Drug-Induced / etiology
  • Adult
  • Antineoplastic Agents / adverse effects*
  • Databases, Factual / statistics & numerical data
  • Female
  • France / epidemiology
  • Humans
  • Infant, Newborn
  • Middle Aged
  • Neoplasms / drug therapy*
  • Pharmacovigilance
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Pregnancy Outcome*
  • Prospective Studies
  • Young Adult


  • Antineoplastic Agents