1. 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
- Author
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Lambertini, Matteo, Martel, Samuel, Campbell, Christine, Guillaume, Sébastien, Hilbers, Florentine, Schuehly, Uwe, Korde, Larissa, Azim, Hatem, Di Cosimo, Serena, Tenglin, Richard, Huober, Jens, Baselga, José, Moreno-Aspitia, Alvaro, Piccart-Gebhart, Martine, Gelber, Richard, De Azambuja, Evandro, Ignatiadis, Michail, Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Université libre de Bruxelles (ULB), Université de Sherbrooke (UdeS), Neuropsychiatrie : recherche épidémiologique et clinique (PSNREC), Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Novartis Pharma AG, National Cancer Institute [Bethesda] (NCI-NIH), National Institutes of Health [Bethesda] (NIH), American University of Beirut [Beyrouth] (AUB), Human Tumor Immunobiology Unit [Fondazione IRCCS Istituto Nazionale dei Tumori, Milan], Fondazione IRCCS Istituto Nazionale Tumori - National Cancer Institute [Milan], Universitätsklinikum Ulm - University Hospital of Ulm, Memorial Sloane Kettering Cancer Center [New York], Mayo Clinic [Jacksonville], Dana-Farber Cancer Institute [Boston], Harvard Medical School [Boston] (HMS), Harvard T.H. Chan School of Public Health, Michel-Avella, Amandine, and Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Cancer Research ,[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology ,breast cancer, human epidermal growth factor receptor 2 (HER2)–positive, lapatinib, pregnancy, survivorship, trastuzumab, young patients, Oncology, Cancer Research ,human epidermal growth factor receptor 2 (HER2)–positive ,young patients ,trastuzumab ,breast cancer ,Oncology ,pregnancy ,lapatinib ,skin and connective tissue diseases ,survivorship ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,human epidermal growth factor receptor 2 (HER2)-positive - Abstract
International audience; 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 the prognosis of patients with a pregnancy after prior early breast cancer, with no data in HER2-positive patients.METHODS:The Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization (NeoALTTO) trial and the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) trial were randomized phase 3 trials for patients with HER2-positive early breast cancer. In both trials, pregnancy information was prospectively collected. Pregnancy outcomes were compared between patients unintentionally exposed to trastuzumab and/or lapatinib during gestation (the exposed group) and those who became pregnant after trastuzumab and/or lapatinib completion (the unexposed group). In the ALTTO trial, disease-free survival (DFS) was compared between pregnant patients and those aged 40 years or younger without a subsequent pregnancy via an extended Cox model with time-varying covariates to account for a guarantee-time bias.RESULTS:Ninety-two patients (12 in the exposed group and 80 in the unexposed group) had a pregnancy: 7 in the NeoALTTO trial and 85 in the ALTTO trial. Seven patients (58.3%) in the exposed group and 10 patients (12.5%) in the unexposed group opted for an induced abortion; in the unexposed group, 10 patients (12.5%) had a spontaneous abortion. No pregnancy/delivery complications were reported for the remaining cases, who successfully completed their pregnancy, with the exception of 1 fetus with trisomy 21 (Down syndrome). No significant difference in DFS (adjusted hazard ratio, 1.12; 95% confidence interval, 0.52-2.42) was observed between young patients with a pregnancy (n = 85) and young patients without a pregnancy (n = 1307).CONCLUSIONS:For patients with HER2-positive early breast cancer, having a pregnancy after treatment completion appears to be safe without compromising fetal outcome or maternal prognosis.
- Published
- 2019