{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T11:06:16Z","timestamp":1789815976792,"version":"4.0.1"},"reference-count":35,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T00:00:00Z","timestamp":1771891200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Fundaci\u00f3n Andaluza de Farmacia Hospitalaria","award":["3000 EUROS"],"award-info":[{"award-number":["3000 EUROS"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Sacituzumab govitecan (SG) releases SN-38, the same active metabolite as irinotecan, thereby sharing key metabolic pathways and toxicity mechanisms. The clearance of SN-38 is strongly influenced by UGT1A1 polymorphisms, particularly the UGT1A1*28 allele. While UGT1A1*28 genotyping routinely guides irinotecan dosing, no such recommendations exist for SG. This study describes the relationship between UGT1A1*28 and severe SG-related toxicity in real-world practice, identifying early safety signals and exploring the clinical and economic impact. Methods: This retrospective observational study (2021\u20132025) included patients with metastatic breast cancer treated with SG and patients with advanced gastrointestinal malignancies treated with irinotecan at a tertiary hospital. In the SG cohort, genotyping followed grade \u22653 toxicity; in the irinotecan cohort, it was performed prospectively. Toxicity (Common Terminology Criteria for Adverse Events version 5.0) and healthcare costs related to hospitalizations were estimated using official institutional tariffs. Results: All nine SG patients with severe toxicity (100%) carried the UGT1A1*28 allele. In the irinotecan cohort (n = 74), which was managed with genotype-guided dosing, severe toxicity and hospitalization were less frequent. SG was associated with higher mean costs per treated patient (\u20ac2817.01 vs. \u20ac1233.63), driven by toxicity-related admissions (33.3% vs. 10.8%). Genotyping costs (\u20ac10.51) were negligible compared to daily hospitalization expenses (up to \u20ac1984.90). Conclusions: Severe SG-related toxicity reveals a consistent UGT1A1*28-associated vulnerability. Given the drug\u2019s recent approval in Spain, these data represent an urgent real-world safety signal. The marked disparity between low genotyping costs and high hospitalization expenses supports implementing preventive UGT1A1 testing to optimize the safety and sustainability of sacituzumab govitecan therapy.<\/jats:p>","DOI":"10.3390\/jcm15051715","type":"journal-article","created":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T16:58:18Z","timestamp":1771952298000},"page":"1715","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["The Early Safety Signal of Sacituzumab Govitecan-Related Toxicity and the UGT1A1*28 Genotype in Metastatic Breast Cancer: A Real-World Preliminary Report"],"prefix":"10.3390","volume":"15","author":[{"given":"Mar\u00eda","family":"Mart\u00ednez-P\u00e9rez","sequence":"first","affiliation":[{"name":"Hospital Pharmacy, Hospital Universitario San Cecilio, 18016 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2240-5015","authenticated-orcid":false,"given":"Mar\u00eda Teresa","family":"Nieto-S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy, Hospital Universitario San Cecilio, 18016 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0849-9902","authenticated-orcid":false,"given":"Xando","family":"D\u00edaz-Villamar\u00edn","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"},{"name":"Department of Pharmacology and Therapeutics, Faculty of Medicine, Autonomous University of Madrid, 28029 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-6132-6228","authenticated-orcid":false,"given":"Alicia","family":"Torres-Garc\u00eda","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8253-6252","authenticated-orcid":false,"given":"Emilio","family":"Fern\u00e1ndez-Var\u00f3n","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"},{"name":"Department of Pharmacology, Center for Biomedical Research (CIBM), University of Granada, 18016 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6799-3727","authenticated-orcid":false,"given":"Alvaro","family":"Prados-Carmona","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"},{"name":"Department of Dermatology, Hospital Universitario San Cecilio, 18016 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8862-6267","authenticated-orcid":false,"given":"Marta","family":"Leger\u00e9n","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"},{"name":"Medical Oncology, Hospital Universitario San Cecilio, 18016 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2161-930X","authenticated-orcid":false,"given":"Jos\u00e9","family":"Cabeza-Barrera","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy, Hospital Universitario San Cecilio, 18016 Granada, Spain"},{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5867-6615","authenticated-orcid":false,"given":"Isabel","family":"Blancas","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"},{"name":"Medical Oncology, Hospital Universitario San Cecilio, 18016 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4461-2247","authenticated-orcid":false,"given":"Roc\u00edo","family":"Mor\u00f3n","sequence":"additional","affiliation":[{"name":"Hospital Pharmacy, Hospital Universitario San Cecilio, 18016 Granada, Spain"},{"name":"Instituto de Investigaci\u00f3n Biosanitaria de Granada (Ibs.Granada), 18012 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"746","DOI":"10.1016\/j.annonc.2021.03.005","article-title":"Sacituzumab govitecan, a Trop-2-directed antibody\u2013drug conjugate, for patients with epithelial cancer: Final safety and efficacy results from the phase I\/II IMMU-132-01 basket trial","volume":"32","author":"Bardia","year":"2021","journal-title":"Ann. 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