{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T04:47:05Z","timestamp":1785732425164,"version":"3.56.0"},"reference-count":37,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T00:00:00Z","timestamp":1785283200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T00:00:00Z","timestamp":1785283200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>\n                    Pregnancy\u2010associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal\u2013fetal safety of systemic anticancer therapies is critical. We performed a case\/non\u2010case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal\u2013fetal 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\u2013fetal 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\u2010specific risks. Of 3310 pregnancy\u2010related reports, 1789 involved BC treatments. Median maternal age was 27.4\u2009years (SD 13.8) vs. 29.3 (SD 11.7) in the comparator group. Adverse maternal\u2013fetal 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\u2009=\u20091.7, 95% CI\u2009=\u20091.1\u20132.5) and intrauterine growth restriction (IUGR) (ROR\u2009=\u20092.1, 95% CI\u2009=\u20091.7\u20132.7). Paclitaxel was linked to sensory defects including congenital ear\/ocular anomalies (ROR\u2009=\u20095.2, 95% CI\u2009=\u20092.2\u201312.3); all 8 cases involved platinum co\u2010exposure (cisplatin:\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20095; carboplatin:\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20093), suggesting a platinum\u2010mediated mechanism; and to hyperbilirubinemia (ROR\u2009=\u20094.1, 95% CI\u2009=\u20092.0\u20138.4), and docetaxel to neonatal neurologic disorders (ROR\u2009=\u20093.6, 95% CI\u2009=\u20091.4\u20139.3). First\u2010trimester exposure (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200926) showed preliminary signals of increased congenital malformation risk, including face (ROR\u2009=\u200913, 95% CI\u2009=\u20092\u201379), and musculoskeletal malformation (ROR\u2009=\u20098, 95% CI\u2009=\u20091.1\u201360). This pharmacovigilance study identifies signals of disproportionate reporting of specific maternal and neonatal outcomes with BC treatments; these findings are hypothesis\u2010generating and require confirmation in prospective registries.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70404","type":"journal-article","created":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T09:43:52Z","timestamp":1785318232000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments\u2014A\n                    <scp>VigiBase<\/scp>\n                    Disproportionality Analysis Study"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5165-9743","authenticated-orcid":false,"given":"Rayan","family":"Kabirian","sequence":"first","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Institut Curie Women's Cancers Institute, Department of Medical Oncology  Paris and Saint\u2010Cloud France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5009-3936","authenticated-orcid":false,"given":"Floriane","family":"Jochum","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7877-719X","authenticated-orcid":false,"given":"Elise","family":"Dumas","sequence":"additional","affiliation":[{"name":"Institute of Mathematics, Ecole Polytechnique F\u00e9d\u00e9rale de Lausanne (EPFL)  Lausanne Switzerland"},{"name":"Residual Tumor &amp; Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer, Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6443-8883","authenticated-orcid":false,"given":"Florence","family":"Coussy","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Institut Curie Women's Cancers Institute, Department of Medical Oncology  Paris and Saint\u2010Cloud France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6797-0237","authenticated-orcid":false,"given":"Kevin","family":"Bihan","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance, Department of Medical Pharmacology, Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital, AP\u2010HP Sorbonne Universit\u00e9  Paris France"},{"name":"French Pharmacovigilance Network. Assistance Publique \u2010 H\u00f4pitaux de Paris (AP\u2010HP)  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6676-5063","authenticated-orcid":false,"given":"B\u00e9n\u00e9dicte","family":"Lebrun\u2010Vignes","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance, Department of Medical Pharmacology, Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital, AP\u2010HP Sorbonne Universit\u00e9  Paris France"},{"name":"French Pharmacovigilance Network. Assistance Publique \u2010 H\u00f4pitaux de Paris (AP\u2010HP)  Paris France"},{"name":"Clinical Investigation Center (CIC\u20101901) Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale (INSERM) and Epidemiology in Dermatology and Evaluation of therapeutics), Universit\u00e9 Paris Est Cr\u00e9teil (UPEC)  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9184-7199","authenticated-orcid":false,"given":"Barbara","family":"Pistilli","sequence":"additional","affiliation":[{"name":"Institut Gustave Roussy, Department of Medical Oncology  Villejuif France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc\u2010Antoine","family":"Benderra","sequence":"additional","affiliation":[{"name":"Institut Universitaire de Canc\u00e9rologie, Sorbonne University, AP\u2010HP, Tenon Hospital, Department of Medical Oncology  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lise","family":"Selleret","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology, and Reproductive Medicine Tenon Hospital, AP\u2010HP, Sorbonne Universit\u00e9  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9626-3571","authenticated-orcid":false,"given":"Laurent","family":"Chouchana","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9, Inserm UMR\u2010S 1343, Pharmacologie et \u00e9valuations des th\u00e9rapeutiques chez l'enfant et la femme enceinte  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabien","family":"Reyal","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Department of Breast, Gynecological and Reconstructive Surgery, Institut Curie Universit\u00e9 Paris  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4430-3022","authenticated-orcid":false,"given":"Anne\u2010Sophie","family":"Hamy","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Institut Curie Women's Cancers Institute, Department of Medical Oncology  Paris and Saint\u2010Cloud France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3064-7043","authenticated-orcid":false,"given":"Paul","family":"Gougis","sequence":"additional","affiliation":[{"name":"Residual Tumor &amp; Response to Treatment Laboratory, RT2Lab, INSERM, U932 Immunity and Cancer Institut Curie, Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Sorbonne Universit\u00e9, Institut national de la sant\u00e9 et de la recherche m\u00e9dicale (INSERM), Assistance Publique \u2010 H\u00f4pitaux de Paris (AP\u2010HP), Clinical Investigation Center (CIC\u20101901), Department of Pharmacology Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital  Paris France"},{"name":"Sorbonne Universit\u00e9, Department of Medical Oncology, Assistance Publique \u2010 H\u00f4pitaux de Paris (AP\u2010HP) Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital, Institut Universitaire de Canc\u00e9rologie  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,29]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"publisher","DOI":"10.1067\/S0002-9378(03)00537-4"},{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.23.2801"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/00130404-200503000-00001"},{"key":"e_1_2_12_4_1","first-page":"70","article-title":"Breast cancer in pregnancy\u2013a diagnostic and therapeutic challenge","volume":"163","author":"Pommier R.F.","year":"1995","journal-title":"West. J. 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J. Gynecol. Cancer"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/CAD.0000000000000093"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.39934"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.5625"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3730"},{"key":"e_1_2_12_19_1","unstructured":"Uppsala Monitoring Centre (UMC) on behalf of the WHO Programme for International Drug Monitoring.About VigiBase<https:\/\/who\u2010umc.org\/vigibase\u2010data\u2010access\/about\u2010vigibase\/> Accessed March 11 2026."},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-024-01421-9"},{"key":"e_1_2_12_21_1","unstructured":"EQUATOR Network.The strengthening the Reporting of Observational studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies<https:\/\/www.equator\u2010network.org\/reporting\u2010guidelines\/strobe\/> Accessed March 11 2026."},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.69.9439"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/tbj.13156"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-017-3772-9"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(04)01466-4"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.2174\/1568011043482205"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00262774"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.1998.375"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.breast.2011.12.012"},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2012.10.007"},{"key":"e_1_2_12_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.nano.2020.102354"},{"key":"e_1_2_12_32_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mds170"},{"key":"e_1_2_12_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clbc.2023.11.007"},{"key":"e_1_2_12_34_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-021-06113-8"},{"key":"e_1_2_12_35_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2015.2413"},{"key":"e_1_2_12_36_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.03.038"},{"key":"e_1_2_12_37_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers12123616"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70404","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70404","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70404","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T04:37:32Z","timestamp":1785731852000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70404"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,29]]},"references-count":37,"alternative-id":["10.1002\/cpt.70404"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70404","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,29]]},"assertion":[{"value":"2026-03-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"cpt.70404"}}