| アブストラクト | Tyrosine kinase inhibitors (TKIs) targeting BCR: :ABL1 have greatly improved the survival of patients with chronic myeloid leukemia (CML), and their teratogenicity appears as an important factor for individuals of childbearing potential. This study aims to investigate pregnancy and fetal/newborn adverse outcomes resulting from exposure to BCR: :ABL1-TKIs during pregnancy. For this disproportionality analysis, we used the WHO's global VigiBase up to January 2024, and included reports involving pregnancy, antineoplastic treatment during pregnancy, and cancer. The exposure group consisted of reports mentioning BCR: BCR: :ABL1-TKIs group compared to other anticancer treatments. The analysis included 3,389 reports (TKI = 969; other = 2,420). :ABL1-TKI-exposed group, the mean age was 28.9 years, and 724 patients (92.2%) were treated for CML. BCR: :ABL1-TKIs were mainly imatinib (n = 642, 66.3%), nilotinib (n = 218, 22.5%), and dasatinib (n = 127, 13.1%) reported without other non-TKI anticancer agents(92.3%). Compared to other anticancer drugs, overreported outcomes with TKIs included hydrops fetalis (ROR = 13 [95%CI = 1.5-110], P = 0.009), polyhydramnios (ROR = 5 [1.3-20], P = 0.02), and threatened preterm labor (ROR = 10 [1.1-90], P = 0.03). When analyzing specific molecule effects, hydrops fetalis (ROR = 27 [5.4-130], P = 0.001) and polyhydramnios (ROR = 13 [3.3-54], P = 0.004) were overreported with dasatinib. In this large cohort of 969 individuals exposed to TKIs during pregnancy, dasatinib use was associated with most BCR: :ABL1-TKI-specific toxicities and should be avoided during pregnancy. Fewer or no adverse events were overreported with imatinib and nilotinib. |
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| 投稿者 | Cabannes-Hamy, Aurelie; Kabirian, Rayan; Jochum, Floriane; Bihan, Kevin; Dumas, Elise; Coussy, Florence; Laas, Enora; Rousselot, Philippe; Choquet, Sylvain; Uzunov, Madalina; Salomon, Laurent; Reyal, Fabien; Hamy, Anne-Sophie; Gougis, Paul |
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| 組織名 | Hematology, Centre Hospitalier de Versailles Site Andre Mignot, Le;Chesnay-Rocquencourt, France.;Residual Tumor & Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity;and Cancer, Institut Curie, Universite Paris Cite, Paris, France.;Department of Gynecology, Strasbourg University Hospital, Strasbourg, France.;Department of Pharmacology, Institut National de la Sante et de la Recherche;Medicale (INSERM), Assistance Publique - Hopitaux de Paris (AP-HP), Clinical;Investigation Center (CIC-1901), Sorbonne Universite, Pitie-Salpetriere Hospital,;Paris, France.;Paris Pitie-St Antoine Regional Pharmacovigilance Center, Medical Pharmacology;Department, APHP Sorbonne University Hospital Group, Paris, France.;Department of Mathematics, Ecole Polytechnique Federale de Lausanne, Lausanne,;Switzerland.;Department of Medical Oncology, Institut Curie, Universite Paris Cite, Paris,;France.;Department of Breast, Gynecological and Reconstructive Surgery, Institut Curie,;Universite Paris Cite, Paris, France.;University of Versailles Paris-Saclay, Versailles, France.;Department of Hematology, Assistance Publique - Hopitaux de Paris (AP-HP),;Sorbonne Universite, Pitie-Salpetriere Hospital, Paris, France.;Department of Obstetrics, Surgery, Fetal Medicine and Imaging, Hopital;Necker-Enfants Malades, Paris, France.;Department of Surgical Oncology, Institut Godinot, Reims, France.;Department of Medical Oncology, Sorbonne Universite, Assistance Publique -;Hopitaux de Paris (AP-HP), Pitie-Salpetriere Hospital, Institut Universitaire de;Cancerologie, Paris, France. |
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