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In this study, we investigated the effectiveness of pembrolizumab as first-line treatment for cisplatin-ineligible UC.<h4>Methods</h4>Data from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study.<h4>Results</h4>Our analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD.<h4>Conclusions</h4>Our data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.","is_dataset_classified":null,"base_score":2.5649493574615367,"endowment":2.5649493574615367,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"37248424","pmcid":"PMC10991859","openalex_id":"https://openalex.org/W4378649910","authors":[],"funders":[],"total_grants":0,"fwci":3.0503,"citation_percentile":0.91874142,"influential_citations":0,"citation_trend":[{"year":2024,"count":7},{"year":2025,"count":5}],"oa_status":"green","license":"other-oa","oa_locations":[{"url":"https://cris.unibo.it/bitstream/11585/927473/3/Santoni_2023.pdf","host_type":"repository"},{"url":"https://cris.unibo.it/bitstream/11585/927473/3/Santoni_2023.pdf","host_type":"repository"},{"url":"https://link.springer.com/content/pdf/10.1007/s00262-023-03469-5.pdf","host_type":"publisher"},{"url":"https://link.springer.com/article/10.1007/s00262-023-03469-5/fulltext.html","host_type":"publisher"},{"url":"https://hdl.handle.net/11585/927473","host_type":"repository"},{"url":"https://doi.org/10.1007/s00262-023-03469-5","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/37248424","host_type":"repository"},{"url":"https://eprints.soton.ac.uk/479883/1/ARON_2_First_line_pembro_PG.docx","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/10991859","host_type":"repository"},{"url":"https://hdl.handle.net/11572/478179","host_type":"repository"},{"url":"https://link.springer.com/article/10.1007/s00262-023-03469-5","host_type":"repository"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10991859/pdf/262_2023_Article_3469.pdf","host_type":"repository"}],"fields_of_study":["Bladder and Urothelial Cancer Treatments","Cancer Immunotherapy and Biomarkers","Ferroptosis and cancer prognosis"],"mesh_terms":["Antineoplastic Combined Chemotherapy Protocols","Urinary Bladder Neoplasms","Carcinoma, Transitional Cell","Cisplatin","Female","Humans","Male","Antibodies, Monoclonal, Humanized"],"keywords":["Pembrolizumab","Medicine","Cisplatin","Internal medicine","Oncology","Metastatic Urothelial Carcinoma","Urothelial carcinoma","Immunotherapy","Chemotherapy","Cancer","Bladder cancer","Urothelial Cancer","Real-world Data","Aron-2 Study","Nct05290038"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[{"name":"nct"}],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-03T11:15:07.937521Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}