{"?xml":{"@version":"1.0"},"edm:RDF":{"@xmlns:dc":"http://purl.org/dc/elements/1.1/","@xmlns:edm":"http://www.europeana.eu/schemas/edm/","@xmlns:wgs84_pos":"http://www.w3.org/2003/01/geo/wgs84_pos","@xmlns:foaf":"http://xmlns.com/foaf/0.1/","@xmlns:rdaGr2":"http://rdvocab.info/ElementsGr2","@xmlns:oai":"http://www.openarchives.org/OAI/2.0/","@xmlns:owl":"http://www.w3.org/2002/07/owl#","@xmlns:rdf":"http://www.w3.org/1999/02/22-rdf-syntax-ns#","@xmlns:ore":"http://www.openarchives.org/ore/terms/","@xmlns:skos":"http://www.w3.org/2004/02/skos/core#","@xmlns:dcterms":"http://purl.org/dc/terms/","edm:WebResource":[{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-5E1FZ0DF/b97fafe0-68e7-49b3-a3db-0c276381f00a/PDF","dcterms:extent":"461 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-5E1FZ0DF/b7bfd97d-1083-4b85-953f-d9a1f2854215/TEXT","dcterms:extent":"46 KB"}],"edm:TimeSpan":{"@rdf:about":"1992-2025","edm:begin":{"@xml:lang":"en","#text":"1992"},"edm:end":{"@xml:lang":"en","#text":"2025"}},"edm:ProvidedCHO":{"@rdf:about":"URN:NBN:SI:doc-5E1FZ0DF","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-FNIFVE9S"},{"@xml:lang":"sl","#text":"Radiology and oncology (Ljubljana)"}],"dcterms:issued":"2022","dc:creator":["Beniak, Juraj","Borštnar, Simona","Gal-Yam, Einav Nili","Kudela, Pavol","Łacko, Aleksandra","Palacova, Marketa","Papazisis, Konstantinos","Rubovszky, Gábor","Timcheva, Constanta"],"dc:format":[{"@xml:lang":"sl","#text":"številka:2"},{"@xml:lang":"sl","#text":"letnik:56"},{"@xml:lang":"sl","#text":"str. 238-247"}],"dc:identifier":["DOI:10.2478/raon-2022-0020","COBISSID_HOST:108184835","ISSN:1318-2099","URN:URN:NBN:SI:doc-5E1FZ0DF"],"dc:language":"en","dc:publisher":{"@xml:lang":"sl","#text":"Association of Radiology and Oncology"},"dc:subject":[{"@xml:lang":"en","#text":"advanced breast cancer"},{"@xml:lang":"en","#text":"CDK4/6 inhibitor"},{"@xml:lang":"en","#text":"HER2-"},{"@xml:lang":"en","#text":"HR+"},{"@xml:lang":"sl","#text":"inhibitor CDK4/6"},{"@xml:lang":"sl","#text":"napredovali rak dojke"},{"@xml:lang":"en","#text":"ribociclib"}],"dcterms:temporal":{"@rdf:resource":"1992-2025"},"dc:title":{"@xml:lang":"sl","#text":"Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy| subgroup safety analysis from the phase 3b CompLEEment-1 trial|"},"dc:description":{"@xml:lang":"sl","#text":"The CDK4/6 inhibitor, ribociclib in combination with endocrine therapy significantly improved progression-free survival in the first line setting in post-menopausal patients with HR+/HER2- advanced breast cancer (ABC) in a pivotal phase 3, placebo-controlled trial (MONALEESA-2) and demonstrated superior overall survival in premenopausal patients with HR+/HER2- ABC (MONALEESA-7). The multinational, phase 3b, CompLEEment-1 trial, which assessed the safety and efficacy of ribociclib plus letrozole in a broader population of patients who have not received prior endocrine therapy for advanced disease, is the largest phase 3 clinical trial to date to evaluate the safety and efficacy of a CDK4/6 inhibitor. We report a subanalysis of data from patients (N = 339) enrolled in the central and south European countries of the SERCE (Southern Europe, RUC, Central Europe) cluster of CompLEEment-1. Patients and methods: Men and women of any menopausal status with HR+/HER2- ABC received once-daily oral ribociclib 600 mg (3-weeks on/1-week-off), plus letrozole 2.5 mg continuously. Men/premenopausal women also received a GnRH-agonist. The primary outcome was the number of patients with adverse events (AEs) over a timeframe of approximately 36 months. Time-to-progression, overall response rate, and clinical benefit rate were also measured. Results: Safety results in the SERCE subgroup were consistent with those in the pivotal clinical trials of ribociclib in combination with endocrine therapy. Treatment-related AEs leading to dose adjustments/interruption occurred in 63.1% of patients but led to treatment discontinuation in only 10.6%. The most common treatment-related AEs of grade ? 3 were neutropenia and transaminase elevations. There were no fatal treatment-related events. Conclusions: These findings from the SERCE subgroup support the safety and manageable tolerability of ribociclib in a broad range of patients with HR+/HER2- ABC more representative of patients in real-world clinical practice"},"edm:type":"TEXT","dc:type":[{"@xml:lang":"sl","#text":"znanstveno časopisje"},{"@xml:lang":"en","#text":"journals"},{"@rdf:resource":"http://www.wikidata.org/entity/Q361785"}]},"ore:Aggregation":{"@rdf:about":"http://www.dlib.si/?URN=URN:NBN:SI:doc-5E1FZ0DF","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:doc-5E1FZ0DF"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:doc-5E1FZ0DF/b97fafe0-68e7-49b3-a3db-0c276381f00a/PDF"},"edm:rights":{"@rdf:resource":"http://creativecommons.org/licenses/by/4.0/"},"edm:provider":"Slovenian National E-content Aggregator","edm:intermediateProvider":{"@xml:lang":"en","#text":"National and University Library of Slovenia"},"edm:dataProvider":{"@xml:lang":"sl","#text":"Društvo radiologije in onkologije"},"edm:object":{"@rdf:resource":"http://www.dlib.si/streamdb/URN:NBN:SI:doc-5E1FZ0DF/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:doc-5E1FZ0DF"}}}}