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Population Pharmacokinetics of Docetaxel, Paclitaxel, Doxorubicin and Epirubicin in Pregnant Women with Cancer: A Study from the International Network of Cancer, Infertility and Pregnancy (INCIP)
JM. Janssen, K. Van Calsteren, TPC. Dorlo, MJ. Halaska, R. Fruscio, P. Ottevanger, CP. Schröder, I. Boere, PO. Witteveen, RC. Painter, R. Bekkers, V. Drochytek, JH. Beijnen, ADR. Huitema, FCH. Amant
Language English Country Switzerland
Document type Journal Article, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 2007-06-01 to 1 year ago
Health & Medicine (ProQuest)
from 2007-06-01 to 1 year ago
- MeSH
- Docetaxel therapeutic use MeSH
- Doxorubicin therapeutic use MeSH
- Epirubicin MeSH
- Infertility * MeSH
- Humans MeSH
- Breast Neoplasms * MeSH
- Neoplasms * drug therapy MeSH
- Paclitaxel MeSH
- Antineoplastic Combined Chemotherapy Protocols MeSH
- Taxoids MeSH
- Pregnancy MeSH
- Pregnant People MeSH
- Check Tag
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
BACKGROUND: Based on reassuring short-term foetal and maternal safety data, there is an increasing trend to administer chemotherapy during the second and third trimesters of pregnancy. The pharmacokinetics (PK) of drugs might change as a result of several physiological changes that occur during pregnancy, potentially affecting the efficacy and safety of chemotherapy. OBJECTIVE: With this analysis, we aimed to quantitatively describe the changes in the PK of docetaxel, paclitaxel, doxorubicin and epirubicin in pregnant women compared with non-pregnant women. METHODS: PK data from 9, 20, 22 and 16 pregnant cancer patients from the International Network of Cancer, Infertility and Pregnancy (INCIP) were available for docetaxel, paclitaxel, doxorubicin and epirubicin, respectively. These samples were combined with available PK data from non-pregnant patients. Empirical non-linear mixed-effects models were developed, evaluating fixed pregnancy effects and gestational age as covariates. RESULTS: Overall, 82, 189, 271, and 227 plasma samples were collected from pregnant patients treated with docetaxel, paclitaxel, doxorubicin and epirubicin, respectively. The plasma PK data were adequately described by the respective models for all cytotoxic drugs. Typical increases in central and peripheral volumes of distribution of pregnant women were identified for docetaxel, paclitaxel, doxorubicin and epirubicin. Additionally, docetaxel, doxorubicin and paclitaxel clearance were increased in pregnant patients, resulting in lower exposure in pregnant women compared with non-pregnant patients. CONCLUSION: Given the interpatient variability, the identified pregnancy-induced changes in PK do not directly warrant dose adjustments for the studied drugs. Nevertheless, these results underscore the need to investigate the efficacy of chemotherapy, when administered during pregnancy.
Department of Development and Regeneration Obstetrics and Gynaecology KU Leuven Leuven Belgium
Department of Medical Oncology Radboudumc Nijmegen The Netherlands
Department of Medical Oncology University Medical Center Groningen Groningen The Netherlands
Department of Medical Oncology University Medical Center Utrecht Utrecht The Netherlands
Department of Oncology Catholic University of Leuven Leuven Belgium
GROW School for Oncology and Developmental Biology Maastricht University Maastricht The Netherlands
Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands
References provided by Crossref.org
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- $a BACKGROUND: Based on reassuring short-term foetal and maternal safety data, there is an increasing trend to administer chemotherapy during the second and third trimesters of pregnancy. The pharmacokinetics (PK) of drugs might change as a result of several physiological changes that occur during pregnancy, potentially affecting the efficacy and safety of chemotherapy. OBJECTIVE: With this analysis, we aimed to quantitatively describe the changes in the PK of docetaxel, paclitaxel, doxorubicin and epirubicin in pregnant women compared with non-pregnant women. METHODS: PK data from 9, 20, 22 and 16 pregnant cancer patients from the International Network of Cancer, Infertility and Pregnancy (INCIP) were available for docetaxel, paclitaxel, doxorubicin and epirubicin, respectively. These samples were combined with available PK data from non-pregnant patients. Empirical non-linear mixed-effects models were developed, evaluating fixed pregnancy effects and gestational age as covariates. RESULTS: Overall, 82, 189, 271, and 227 plasma samples were collected from pregnant patients treated with docetaxel, paclitaxel, doxorubicin and epirubicin, respectively. The plasma PK data were adequately described by the respective models for all cytotoxic drugs. Typical increases in central and peripheral volumes of distribution of pregnant women were identified for docetaxel, paclitaxel, doxorubicin and epirubicin. Additionally, docetaxel, doxorubicin and paclitaxel clearance were increased in pregnant patients, resulting in lower exposure in pregnant women compared with non-pregnant patients. CONCLUSION: Given the interpatient variability, the identified pregnancy-induced changes in PK do not directly warrant dose adjustments for the studied drugs. Nevertheless, these results underscore the need to investigate the efficacy of chemotherapy, when administered during pregnancy.
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