Prospective, observational registry of branded imatinib and nilotinib exposure in pregnant women: Voluntary postauthorization safety study.

Abstract

TPS205 Background: Family planning decisions for patients of child-bearing age are impacted by their cancer diagnosis. Imatinib and nilotinib are category D drugs (ie, demonstrated risk to the fetus; however, the benefits of therapy may outweigh the potential risk to the fetus). Limited data exist concerning the safety of these drugs during pregnancy and the consequences of interrupting treatment. The Registry does not recommend patients receiving imatinib or nilotinib become pregnant, but serves only to document exposures that occur, and to collect information on the pregnancy outcome, maternal course of disease, and infant follow-up. Methods: The registry intends to enroll 225 women (≥18 years) treated with branded-only imatinib and nilotinib within 6 months prior to or during pregnancy (generic imatinib and nilotinib reports are excluded). The schedule of visits and treatment are according to local standard of care. Women are divided into two cohorts: 1) pregnancy/fetal: received tyrosine kinase inhibitors (TKIs) within 14 days of conception or at any time during pregnancy; 2) interrupted TKI: received TKIs within 6 months prior to conception but interrupted TKIs in preparation for/as a result of pregnancy. To identify signals of teratogenicity, the registry uses a general population baseline rate of birth defects, and the prevalence of defects in cohorts 1 and 2 may be compared. Cases will be quantitatively analyzed for the emergence of unique or patterns of defects. The primary objective is to monitor TKI-exposed pregnancies to estimate the prevalence of birth defects (calculated by dividing number of birth defects by total number of exposed live births from cohort 1. The secondary objectives are to: 1) determine the impact of treatment interruption on maternal disease status; 2) to assess and estimate the prevalence of serious adverse pregnancy outcomes; 3) and to assess and estimate the prevalence of developmental delays and functional deficits among infants during the first year of life. Maternal disease status is analyzed comparing disease status at registration, pregnancy outcome, and 1-year after birth, stratified by length of TKI interruption.