| アブストラクト | Pregnancy-associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal-fetal safety of systemic anticancer therapies is critical. We performed a case/non-case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal-fetal outcomes associated with breast cancer (BC) systemic treatments. The exposure group consisted of reports mentioning a BC treatment at any time during pregnancy. The primary outcome was the reporting odds ratio (ROR) of maternal-fetal complications with the two cornerstone cytotoxic classes, anthracyclines (doxorubicin, epirubicin) and taxanes (docetaxel, paclitaxel), assessed individually vs. other anticancer treatments. Secondary analyses assessed all BC treatments and trimester-specific risks. Of 3310 pregnancy-related reports, 1789 involved BC treatments. Median maternal age was 27.4 years (SD 13.8) vs. 29.3 (SD 11.7) in the comparator group. Adverse maternal-fetal outcomes were reported in 998 (55.8%) BC treatment reports vs. 470 (30.9%) in other anticancer treatments. Anthracyclines were associated with neonatal hematologic disorders (ROR = 1.7, 95% CI = 1.1-2.5) and intrauterine growth restriction (IUGR) (ROR = 2.1, 95% CI = 1.7-2.7). Paclitaxel was linked to sensory defects including congenital ear/ocular anomalies (ROR = 5.2, 95% CI = 2.2-12.3); all 8 cases involved platinum co-exposure (cisplatin: n = 5; carboplatin: n = 3), suggesting a platinum-mediated mechanism; and to hyperbilirubinemia (ROR = 4.1, 95% CI = 2.0-8.4), and docetaxel to neonatal neurologic disorders (ROR = 3.6, 95% CI = 1.4-9.3). First-trimester exposure (n = 26) showed preliminary signals of increased congenital malformation risk, including face (ROR = 13, 95% CI = 2-79), and musculoskeletal malformation (ROR = 8, 95% CI = 1.1-60). This pharmacovigilance study identifies signals of disproportionate reporting of specific maternal and neonatal outcomes with BC treatments; these findings are hypothesis-generating and require confirmation in prospective registries. |
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| 投稿者 | Kabirian, Rayan; Jochum, Floriane; Dumas, Elise; Coussy, Florence; Bihan, Kevin; Lebrun-Vignes, Benedicte; Pistilli, Barbara; Benderra, Marc-Antoine; Selleret, Lise; Chouchana, Laurent; Reyal, Fabien; Hamy, Anne-Sophie; Gougis, Paul |
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| 組織名 | Residual Tumor & Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity;and Cancer, Institut Curie, Universite Paris Cite, Paris, France.;Institut Curie Women's Cancers Institute, Department of Medical Oncology, Paris;and Saint-Cloud, France.;Institute of Mathematics, Ecole Polytechnique Federale de Lausanne (EPFL),;Lausanne, Switzerland.;Regional Center of Pharmacovigilance, Department of Medical Pharmacology,;Pitie-Salpetriere Hospital, AP-HP Sorbonne Universite, Paris, France.;French Pharmacovigilance Network. Assistance Publique - Hopitaux de Paris;(AP-HP), Paris, France.;Clinical Investigation Center (CIC-1901), Institut National de la Sante et de la;Recherche Medicale (INSERM) and Epidemiology in Dermatology and Evaluation of;therapeutics), Universite Paris Est Creteil (UPEC), Paris, France.;Institut Gustave Roussy, Department of Medical Oncology, Villejuif, France.;Institut Universitaire de Cancerologie, Sorbonne University, AP-HP, Tenon;Hospital, Department of Medical Oncology, Paris, France.;Department of Obstetrics, Gynecology, and Reproductive Medicine, Tenon Hospital,;AP-HP, Sorbonne Universite, Paris, France.;Universite Paris Cite, Inserm UMR-S 1343, Pharmacologie et evaluations des;therapeutiques chez l'enfant et la femme enceinte, Paris, France.;Department of Breast, Gynecological and Reconstructive Surgery, Institut Curie,;Universite Paris, Paris, France.;Sorbonne Universite, Institut national de la sante et de la recherche medicale;(INSERM), Assistance Publique - Hopitaux de Paris (AP-HP), Clinical Investigation;Center (CIC-1901), Department of Pharmacology, Pitie-Salpetriere Hospital, Paris,;France.;Sorbonne Universite, Department of Medical Oncology, Assistance Publique -;Hopitaux de Paris (AP-HP), Pitie-Salpetriere Hospital, Institut Universitaire de;Cancerologie, Paris, France. |
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