Pregnancies during and after trastuzumab and/or lapatinib in patients with human epidermal growth factor receptor 2–positive early breast cancer: Analysis from the NeoALTTO (BIG 1-06) and ALTTO (BIG 2-06) trials

摘要: BACKGROUND: Limited data exist on the safety of using anti-human epidermal growth factor receptor 2 (HER2) targeted agents during pregnancy. To date, only retrospective studies have assessed prognosis patients with a pregnancy after prior early breast cancer, no in HER2-positive patients. METHODS: The Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization (NeoALTTO) trial and Adjuvant (ALTTO) were randomized phase 3 trials for cancer. In both trials, information was prospectively collected. Pregnancy outcomes compared between unintentionally exposed to trastuzumab lapatinib gestation (the group) those who became pregnant completion unexposed group). ALTTO trial, disease-free survival (DFS) aged 40 years or younger without subsequent via an extended Cox model time-varying covariates account guarantee-time bias. RESULTS: Ninety-two (12 group 80 had pregnancy: 7 NeoALTTO 85 trial. Seven (58.3%) 10 (12.5%) opted induced abortion; group, spontaneous abortion. No pregnancy/delivery complications reported remaining cases, successfully completed their pregnancy, exception 1 fetus trisomy 21 (Down syndrome). significant difference DFS (adjusted hazard ratio, 1.12; 95% confidence interval, 0.52-2.42) observed young (n = 85) 1307). CONCLUSIONS: For having treatment appears be safe compromising fetal outcome maternal prognosis.