TY - JOUR
T1 - The impact of dasatinib on pregnancy outcomes
AU - Cortes, Jorge E.
AU - Abruzzese, Elisabetta
AU - Chelysheva, Ekaterina
AU - Guha, Mausumee
AU - Wallis, Nicola
AU - Apperley, Jane F.
N1 - Funding Information:
The authors would like to thank all participating study sites and the patients and physicians who reported the spontaneous cases used in this BMS-sponsored analysis. J.F.A. is grateful for the support of the NIHR Biomedical Research Centre. Thank you to Kary Thompson for assistance with the preclinical studies. Professional medical writing and editorial assistance was provided by Samantha L. Dwyer, PhD, and Rebecca A. Rozich, PhD, of StemScientific, an Ashfield Company, part of UDG Healthcare plc, funded by BMS. The authors did not receive financial compensation from BMS for authoring this manuscript.
Publisher Copyright:
© 2015 Wiley Periodicals, Inc.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2015/12/1
Y1 - 2015/12/1
N2 - Prolonged survival in patients with chronic myeloid leukemia treated with BCR-ABL1-targeted tyrosine kinase inhibitors allows consideration of parenthood for patients on chronic therapy, but there are limited data about the effects of dasatinib on pregnancy. Pregnancy-related outcomes in dasatinib-treated patients or their partners reported to Bristol-Myers Squibb from clinical trials or healthcare providers through December 2013 were reviewed. Outcomes were available in 46/78 dasatinib-treated women (59%) and 33/69 partners of dasatinib-treated men (48%). Fifteen women (33%) delivered a normal infant; 18 (39%) and 8 (17%) had an elective or spontaneous abortion; and 5 (11%) had an abnormal pregnancy. There were 7 reports of fetal/infant abnormalities (encephalocele, renal tract abnormalities, and hydrops fetalis). Thirty of 33 (91%) infants fathered by dasatinib-treated men were reported normal at birth. Also, animal studies evaluated the impact of dasatinib on fertility, embryo-fetal toxicity, and development, suggesting that dasatinib may be a selective developmental toxicant. The outcomes of most pregnancies conceived by men treated with dasatinib were normal, but due to the small number of cases, further monitoring is required. Significant effects on pregnancy outcomes in women treated with dasatinib were found, supporting current recommendations that women avoid becoming pregnant during dasatinib treatment and be informed of fetal risks.
AB - Prolonged survival in patients with chronic myeloid leukemia treated with BCR-ABL1-targeted tyrosine kinase inhibitors allows consideration of parenthood for patients on chronic therapy, but there are limited data about the effects of dasatinib on pregnancy. Pregnancy-related outcomes in dasatinib-treated patients or their partners reported to Bristol-Myers Squibb from clinical trials or healthcare providers through December 2013 were reviewed. Outcomes were available in 46/78 dasatinib-treated women (59%) and 33/69 partners of dasatinib-treated men (48%). Fifteen women (33%) delivered a normal infant; 18 (39%) and 8 (17%) had an elective or spontaneous abortion; and 5 (11%) had an abnormal pregnancy. There were 7 reports of fetal/infant abnormalities (encephalocele, renal tract abnormalities, and hydrops fetalis). Thirty of 33 (91%) infants fathered by dasatinib-treated men were reported normal at birth. Also, animal studies evaluated the impact of dasatinib on fertility, embryo-fetal toxicity, and development, suggesting that dasatinib may be a selective developmental toxicant. The outcomes of most pregnancies conceived by men treated with dasatinib were normal, but due to the small number of cases, further monitoring is required. Significant effects on pregnancy outcomes in women treated with dasatinib were found, supporting current recommendations that women avoid becoming pregnant during dasatinib treatment and be informed of fetal risks.
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U2 - 10.1002/ajh.24186
DO - 10.1002/ajh.24186
M3 - Article
C2 - 26348106
AN - SCOPUS:84954220288
VL - 90
SP - 1111
EP - 1115
JO - American Journal of Hematology
JF - American Journal of Hematology
SN - 0361-8609
IS - 12
ER -