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This study evaluates real-world evidence of avelumab as first-line maintenance therapy in patients with locally advanced or metastatic urothelial carcinoma (la\/mUC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/Patients<\/jats:title>\n                    <jats:p>This was a multicenter, observational, retrospective and prospective study conducted in 22 Spanish centers. Patients were selected based on existing medical records of those treated with avelumab as first-line maintenance therapy before initiating the study (retrospective data), and those who continued to receive avelumab until the end of treatment or end of study (prospective data). Endpoints included median progression-free survival (mPFS), median overall survival (mOS) when available, PFS rate at 12\u00a0months (PFS12) and safety profile.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 125 patients enrolled, 113 were evaluable. The median follow-up of avelumab treatment was 10.7\u00a0months. Disease progression was the main reason for discontinuation in 70 (61.9%) patients, with a median time to progression disease of 6.8\u00a0months. The survival probability was 21.4% for mPFS, with progression disease or death in 67.3% of patients; 44.9% for PFS12, with progression disease or death in 52.2% of patients; and 92.2% for mOS, with death in 2.6% of patients. Adverse events (AEs) were reported in 12.4% of patients; 65.0% of AEs not related to avelumab, and 35.0% were serious (SAEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The real-world results support the effectiveness and manageable safety profile of avelumab as first-line in stage IV urothelial carcinoma. Further prospective studies with longer follow-up are warranted to confirm these findings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s12094-025-03978-y","type":"journal-article","created":{"date-parts":[[2025,7,10]],"date-time":"2025-07-10T09:31:00Z","timestamp":1752139860000},"page":"254-264","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Real-world data on avelumab in first-line maintenance therapy for advanced or metastatic urothelial carcinoma: the SOGUG-AVELUMAB RWD study"],"prefix":"10.1007","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5283-9754","authenticated-orcid":false,"given":"Ovidio","family":"Fern\u00e1ndez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurea","family":"Molina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Urbano","family":"Anido-Herranz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Alvarez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regina","family":"Giron\u00e9s","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"Gajate","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roc\u00edo Garc\u00eda","family":"Dom\u00ednguez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silverio","family":"Ros","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Puente","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Blasco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mart\u00edn","family":"Or\u00e9-Arce","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther Noguer\u00f3n","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Fern\u00e1ndez-Freire","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nieves","family":"del Pozo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Cassinello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mart\u00edn","family":"L\u00e1zaro-Quintela","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Arranz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Crespo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Teresa","family":"Abad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar","family":"Llorente","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"S\u00e1nchez-Hern\u00e1ndez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Jos\u00e9","family":"Juan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,7,9]]},"reference":[{"issue":"22","key":"3978_CR1","doi-asserted-by":"publisher","first-page":"11536","DOI":"10.26355\/eurrev_202011_23795","volume":"24","author":"G Facchini","year":"2020","unstructured":"Facchini G, Cavaliere C, Romis L, et al. 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Aurea Molina has received honoraria from BMS, Eisai, Gr\u00fcnenthal Pharma, Ipsen, Kyowa Kirirn, Merck, Pharmamar, and Roche; travel support from Astellas, Astra Zeneca, BMS, Eisai, Kyowa Kirirn, Lilly, Merck, MSD, Pfizer, Pharmamar, Pierre Fabre, Roche, Sanofi, and Takeda; participation on Advisory Boards from Bayer, Eisai, Pfizer, Pharmamar, and Pierre Fabre. Urbano Anido-Herranz has received fees for consultant or advisory board from Advanced Accelerator Applications, Astellas, Astra Zeneca, Bayer, BMS, GSK, Ipsen, Merck, MSD, and Pfizer; travel support from Advanced Accelerator Applications, Bayer, Ipsen, Merck, Pfizer, Roche, and Sanofi; and honoraria from Advanced Accelerator Applications, Astra Zeneca, BMS, Eisai, Gr\u00fcnenthal Pharma, Ipsen, Leo Pharma (an immediate family member), Merck, and Rovi. Carlos Alvarez has received honoraria from Astra Zeneca, Bayer, and Pfizer; travel support from Ipsen, Pfizer, and Roche. Regina Giron\u00e9s has received fees for speaker or expert testimony from Astellas, Astra Zeneca, Bayer, BMS, Ipsen, Janssen, Merck, MSD, Noartis, Novocure, Pfizer, and Roche; travel support from Astra Zeneca, Bayer, Novartis, and Pfizer. Pablo Gajate has received fees for advisory\/consultancy roles or speaker from AAA, Astellas, Bayer, Bristol-Myers-Squibb, Eisai, Ipsen, Janssen, Merck, MSD, Pfizer, Roche, and Sanofi. Silverio Ros has received honoraria from Bayern, Bristol Mayer, and Roche; fees for expert testimony from Bristol Mayer, Roche, and Sanofi; travel support from Ipsen, Merck, and Pierre Fabre; participation on Advisory Boards from Bristol Mayer, and Roche. Javier Puente has received fees for consultancy from Gilead, Pfizer and Roche; honoraria for lectures from Astra Zeneca, BMS, Eisai, Janssen, Merck, MSD, and Pfizer; travel support from Janssen, Merck, and Pfizer; participation on Advisory Boards from Astra Zeneca, BMS, Gilead, Janssen, Merck, MSD, and Pfizer. Sara Blasco has received grants or honoraria from Merck; travel support from BMS. Nieves del Pozo has received travel support from posESMO GU. Mart\u00edn L\u00e1zaro Quintela has received fees for speaker or expert testimony from Amgen, Astellas, Astra Zeneca, Bayer, BMS, Ipsen, Merck, MSD, Olpsen, Pfizer, and Roche; travel support from Ipsen, MSD, Roche and Takeda. Guillermo Crespo has received fees for consultancy and honoraria from Astellas, BMS, Esteve, Ipsen, Janssen, Merck, MSD, Novartis, and Sanofi; travel support from BMS, Esteve, Ipsen, Janssen, Merck, MSD, and Novartis. Alfredo S\u00e1nchez-Hern\u00e1ndez has received honoraria from Astra Zeneca, BMS, Janssen, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, and Takeda; travel support from BMS, Janssen, MSD, Pfizer, Roche, Sanofi, and Takeda. Mar\u00eda Jos\u00e9 Juan has received support for the present manuscript from Merck; fees for consultancy or honoraria from Astellas, Astra Zeneca, Bayer, Johnson and Johnson, Ipsen, MSD, and Pfizer; travel support from Bayer, Johnson and Johnson, Ipsen, and MSD; participation on Advisory Boards from Bayer, Ipsen, and MSD. Roc\u00edo Garc\u00eda Dom\u00ednguez, Mart\u00edn Or\u00e9-Arce, Esther Noguer\u00f3n Mart\u00ednez, Ana Fern\u00e1ndez-Freire, Javier Casinello, Fernando Arranz, Mar\u00eda Teresa Abad, and Mar Llorente have declared no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Research approval was obtained from the corresponding Research Ethic Committee for medicinal products (CEIm) where centers are located.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"The informed consent was obtained from all patients.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}