Pharmacokinetic study of erlotinib in a pregnant woman with advanced non‐small cell lung cancer and observation of the effects on the child growth

Author:

Aida Yuka12ORCID,Ohgami Masahiro3,Mukai Yuji4ORCID,Matsuyama Masashi1,Obata‐Yasuoka Mana5,Satoh Toyomi5,Homma Masato46,Sekine Ikuo2,Hizawa Nobuyuki1

Affiliation:

1. Department of Respiratory Medicine University of Tsukuba Hospital Tsukuba Japan

2. Department of Medical Oncology University of Tsukuba Hospital Tsukuba Japan

3. Department of Pharmacy Ibaraki Prefectural Central Hospital Kasama Japan

4. Department of Pharmacy University of Tsukuba Hospital Tsukuba Japan

5. Department of Obstetrics and Gynecology, Institute of medicine University of Tsukuba Tsukuba Japan

6. Department of Pharmaceutical Sciences, Graduate School of Comprehensive Human Sciences University of Tsukuba Tsukuba Japan

Abstract

AbstractAimsThe aim of the study is to report the clinical and pharmacological observations from a pregnant patient treated with erlotinib in the second and third trimesters of pregnancy.MethodsMaternal and neonatal blood levels and safety of erlotinib and its metabolites were evaluated. Child development was monitored for 6 years.ResultsA 31‐year‐old woman with stage IV lung adenocarcinoma with EGFR exon19 deletion began treatment with erlotinib 150 mg/day at 17 weeks of gestation. Although foetal growth retardation and oligohydramnios were observed at several times during the pregnancy, treatment was continued due to the severity of the maternal presentation, with ongoing foetal monitoring. The foetus seemed to tolerate and recover well without specific interventions. A healthy baby boy was delivered at 37 weeks gestation. The child grew and developed without any obvious issues. At last follow‐up, at age 6 years, he was attending school at a grade appropriate for his age without health or developmental problems. Blood levels of erlotinib were 397–856 ng/mL at 18–37 weeks of gestation and 1190 ng/mL at 8 weeks postpartum. The blood concentration ratios of OSI‐413‐to‐erlotinib ranged from 0.167 to 0.253 at 18–37 weeks of gestation, excluding 24 weeks, and 0.131 at 8 weeks postpartum. The maternal‐to‐foetal transfer rate of erlotinib, OSI‐420 and OSI‐413 were 24.5, 34.8 and 20.3%, respectively.ConclusionErlotinib use during the second and third trimester of pregnancy did not seem to cause any untoward effects on the developing foetus, or any long‐lasting effects that could be detected during 6 years of follow‐up of the child.

Publisher

Wiley

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