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/api/ratingtype/10002 sjr true true ClassificationExternal 2730 /api/classificationexternal/2730 true 2730 true Q1 DIRECT true true /api/publication/35159096 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Fekete Bertalan </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10053048"><a href="/gui2/?type=authors&mode=browse&sel=10053048" target="_blank">Biró Krisztina (<span class="authorship-author-name">Bíró Krisztina</span> <span class="authorAux-mtmt"> Orvostudomány</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10006848"><a href="/gui2/?type=authors&mode=browse&sel=10006848" 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target="_blank">Géczi Lajos (<span class="authorship-author-name">Géczi Lajos</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10001006"><a href="/gui2/?type=authors&mode=browse&sel=10001006" target="_blank">Patócs Attila (<span class="authorship-author-name">Patócs Attila Balázs</span> <span class="authorAux-mtmt"> Orvostudomány</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet; <span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Intézet">I</span>/Laboratóriumi Medicina Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10038262"><a href="/gui2/?type=authors&mode=browse&sel=10038262" target="_blank">Budai Barna ✉ (<span class="authorship-author-name">Budai Barna</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;35159096" target="_blank">Prediction of PSA Response after Dexamethasone Switch during Abiraterone Acetate + Prednisolone Treatment of Metastatic Castration-Resistant Prostate Cancer Patients</a></div> <div> <span class="journal-title">CANCERS</span> <span class="journal-issn">( <a target="_blank" href="https://portal.issn.org/resource/ISSN/2072-6694">2072-6694</a>)</span>: <span class="journal-volume">16</span> <span class="journal-issue">15</span> <span class="page"> Paper 2760. 13 p. </span> <span class="year">(2024)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.3390/cancers16152760" target="_blank" href="https://doi.org/10.3390/cancers16152760"> DOI </a> </span> <span 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class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;35159096&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 35159096</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="funder"> (National Tumor Biology Laboratory (2022–2.1.1-NL-2022-00010))), Hungarian Thematic Excellence Program((TKP2021-EGA-44)) </div> <div class="lastModified">Utolsó módosítás: 2024.08.26. 10:03 Szalóky-Siki Ágnes (SE_KK_Admin5_SZSA, admin) </div> </div></div> JournalArticle 35499700 VALIDATED true Department of Medical Oncology, Centre Léon Bérard, Lyon, France Vall d’Hebron Institute of Oncology, Vall d´Hebron University Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain Barts Cancer Centre, St Bartholomew’s Hospital, London, United Kingdom Barts Cancer Institute, Barts Health NHS Trust, Queen Mary University of London, London, United Kingdom University of Michigan Health System, Ann Arbor, MI, United States Division of Medical Oncology, Department of Internal Medicine, Cerrahpaşa School of Medicine, Istanbul University-Cerrahpaşa, Istanbul, Turkey County Oncology Centre, Hetényi Géza Hospital, Szolnok, Hungary Institut Gustave Roussy, Université Paris-Saclay, Villejuif, France Medical Oncology Department, Hospital del Mar Research Institute, Barcelona, Spain Medical Oncology Center, The National Tumor Biology Laboratory, National Institute of Oncology, Budapest, Hungary Sunnybrook Health Sciences Centre, Odette Cancer Centre, Toronto, Canada CHU de Québec-Université Laval, Quebec City, Canada Georges Pompidou European Hospital, University Paris Cité, Paris, France Department of Medical Oncology, Maria Middelares Hospital, Gent, Belgium Center for Oncological Research (CORE), University of Antwerp, Antwerp, Belgium Istinye University Liv Hospital, Istanbul, Turkey Minimally Invasive Therapeutics Laboratory, Mayo Clinic, Scottsdale, AZ, United States Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States Division of Hematology and Oncology, Department of Medicine, University of Washington, Seattle, WA, United States Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, United States UGC Medical Oncology, Hospital Regional Universitario de Málaga, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain Department of Medical Oncology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain Department of Medical Oncology, Ankara Yıldırım Beyazıt University Faculty of Medicine, Ankara Bilkent City Hospital, Ankara, Turkey Department of Medical Oncology, Paoli-Calmettes Institute, Marseille, France Institute of Radiotherapy and Clinical Oncology, Borsod-Abaúj-Zemplén County Hospital, University Teaching Hospital, Miskolc, Hungary Leningrad Regional Oncology Dispensary, Ulitsa Savushkina, Saint Petersburg, Russian Federation Department of Medical Oncology, Hopital Cochin, Institut du Cancer Paris, Cancer Research for Personalized Medicine (CARPEM), AP-HP Centre, Université de Paris Cité, Paris, France Merck & Co., Inc., Rahway, NJ, United States National Cancer Center Hospital East, Chiba, Japan Centre Léon Bérard, 28 rue Laennec, Lyon, 69008, France Export Date: 15 January 2025 CODEN: CCREF Chemicals/CAS: pembrolizumab, 1374853-91-4; platinum, 7440-06-4; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunological; B7-H1 Antigen; Biomarkers, Tumor; CD274 protein, human; pembrolizumab Tradenames: Chemagic STAR DNA Blood Kit, Perkin Elmer; FoundationOne CDx; QIAamp DNA FFPE Tissue Kit, Qiagen; Quantidex qPCR DNA QC Assay, Asuragen; Qubit assay, Invitrogen; R version 4.0.5 Manufacturers: Asuragen; Invitrogen; Merck, United States; Perkin Elmer; Qiagen 0 false 2026-01-02T09:49:53.561+0000 2025-01-21T10:21:56.213+0000 2024-11-05T07:25:55.102+0000 true 10081340 Pirmann Tamás /api/admin/10081340 Admin true 2025-01-21T10:21:52.393+0000 2025-01-21T10:21:52.393+0000 2025-01-21T10:21:56.361+0000 true 10083379 Belházyné Szombathelyi Ágnes /api/admin/10083379 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Fléchon, Aude Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma. true true /api/journal/1405637 REVIEWED true false 1405637 false 1405637 true 1078-0432 1557-3265 Journal FOREIGN 30 23 5353 5364 5353 12 2024 The three-arm, phase III KEYNOTE-361 study did not meet its dual primary endpoints of progression-free survival (PFS) or overall survival (OS) with first-line pembrolizumab plus chemotherapy versus chemotherapy in advanced urothelial carcinoma. This prespecified exploratory analysis assessed the association of tumor mutational burden (TMB) and PD-L1 combined positive score (CPS) with clinical outcomes.TMB and PD-L1 CPS were determined via whole-exome sequencing and PD-L1 IHC 22C3 pharmDx, respectively. The association was evaluated in each treatment arm using logistic regression [objective response rate (ORR)] and Cox proportional hazards regression models (PFS and OS); one-sided (pembrolizumab monotherapy; pembrolizumab plus chemotherapy) and two-sided (chemotherapy) nominal P values were calculated. Significance was prespecified at α = 0.05 without multiplicity adjustment. Efficacy was evaluated by prespecified cutoffs of 175 mutations/exome (TMB) and CPS 10 (PD-L1).Of the 993 treated patients, 820 (82.6%) and 993 (100%) had evaluable TMB and CPS data, respectively. Continuous TMB was positively associated with ORR, PFS, and OS for pembrolizumab monotherapy (one-sided P < 0.001, P < 0.001, and P = 0.007, respectively); PFS and OS for pembrolizumab plus chemotherapy (one-sided P = 0.007 and P = 0.010, respectively); and OS for chemotherapy alone (two-sided P = 0.040). Continuous PD-L1 CPS showed evidence of anticipated association with ORR and PFS for pembrolizumab monotherapy. The subgroup with TMB ≥175 mutations/exome and PD-L1 CPS ≥10 had the highest PFS and OS improvements with pembrolizumab alone or with chemotherapy versus chemotherapy alone.These data suggest that TMB may be predictive of the response to pembrolizumab alone or with chemotherapy in advanced urothelial carcinoma. true INTERNATIONAL 2024 true true true false true false NONE 2026-01-02 false 4 0 4 4 0 4 4 4 3 4 4 4 4 4 0 0 4 4 4 4 0 1 1 D1 false 10034949 false false false 2025-01-20T10:21:56.111+0000 Országos Onkológiai Intézet 1 5 1 31 0 true Language 10002 /api/language/10002 Angol English true 2 true PersonAuthorship 121162838 /api/authorship/121162838 1 0.0 true false true Fléchon Aude true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 121162839 /api/authorship/121162839 2 0.0 false false false Morales-Barrera Rafael true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 121162840 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(31) </div> <div><a target="_blank" href="/api/publication/35499700?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;35499700" target="_blank">Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma.</a></div> <div> <span class="journal-title">CLINICAL CANCER RESEARCH</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/1078-0432">1078-0432</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1557-3265">1557-3265</a>)</span>: <span class="journal-volume">30</span> <span class="journal-issue">23</span> <span class="page"> pp 5353-5364 </span> <span class="year">(2024)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1158/1078-0432.CCR-23-3518" target="_blank" href="https://doi.org/10.1158/1078-0432.CCR-23-3518"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="001369693000025" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/001369693000025"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85210932518" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85210932518"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="39475359" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=39475359&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Cancer Research&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 4</span> | Független: 4 | Függő: 0 | Nem jelölt: 0 | WoS jelölt: 4 | Scopus jelölt:&nbsp;3 | WoS/Scopus jelölt:&nbsp;4 | DOI jelölt:&nbsp;4 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;35499700&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 35499700</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2025.01.21. 11:21 Belházyné Szombathelyi Ágnes (SZTE admin5) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Department of Medical Oncology, Centre Léon Bérard, Lyon, France Vall d’Hebron Institute of Oncology, Vall d´Hebron University Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain Barts Cancer Centre, St Bartholomew’s Hospital, London, United Kingdom Barts Cancer Institute, Barts Health NHS Trust, Queen Mary Univer...</pre> </div></div> JournalArticle 34971900 VALIDATED true Export Date: 14 January 2025 Correspondence Address: Sternberg, C.N.; Englander Institute for Precision Medicine, 413 East 69th Street, United States; email: cns9006@med.cornell.edu 0 false 2026-03-10T06:54:16.013+0000 2025-04-07T10:12:04.549+0000 2024-06-10T12:56:53.573+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true 2025-03-17T09:32:52.404+0000 2025-03-17T09:32:52.404+0000 2025-04-07T10:12:01.327+0000 true 10051300 Háromszéki-Virág Fruzsina /api/admin/10051300 Admin true 10051300 2025-04-07T10:12:04.766+0000 true 10051300 Háromszéki-Virág Fruzsina /api/admin/10051300 Admin true 10051300 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Sternberg, Cora N Final Results from SAUL, a Single-arm International Study of Atezolizumab in Unselected Patients with Pretreated Locally Advanced/Metastatic Urinary Tract Carcinoma true true /api/journal/10050020 REVIEWED true false 10050020 false 10050020 true 2405-4569 Journal FOREIGN 10 6 938 946 938 9 2024 We assessed the safety of atezolizumab in unselected patients (including understudied populations typically excluded from clinical trials) with pretreated urinary tract carcinoma (UTC). The prespecified final analysis updates previously reported safety and efficacy data.The single-arm prospective SAUL study (NCT02928406) enrolled 1004 patients with locally advanced/metastatic urothelial/non-urothelial UTC that had progressed during/after one to three prior treatment lines for advanced UTC (or <12 mo after [neo]adjuvant therapy). Broad eligibility criteria allowed enrollment of patients with complex comorbidities approximating the real-world setting. Patients received atezolizumab 1200 mg every 3 wk until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included duration of response and overall survival (OS).The treated cohort included 10% of patients with poor performance status, 5% with creatinine clearance <30 ml/min, and 4% with autoimmune disease. At median follow-up of 55 mo, median atezolizumab duration was 2.8 mo (range 0-62); 68 patients (7%) continued atezolizumab for >4 yr. Treatment-related grade ≥3 adverse events occurred in 16% of patients (death in 1%); 8% discontinued atezolizumab for adverse events. Median OS was 8.6 mo (95% confidence interval 7.8-9.7) and 136 patients (14%) had OS longer than 4 yr. Limitations include the small sample size for some subgroups of special interest.Long-term safety and efficacy data continue to show a benefit of atezolizumab in unselected patients with UTC. Remarkably, 14% of patients lived for >4 yr after starting atezolizumab. These results can inform multidisciplinary team discussions and treatment decision-making for patients with UTC with complex comorbidities.The SAUL study looked at how well tolerated a drug called atezolizumab was in patients with urinary tract cancer who had already received up to three previous treatments for their cancer, including people who are usually not included in clinical trials because of other medical conditions. The length of survival after starting treatment was also assessed. Overall, the results show that atezolizumab was well tolerated. 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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=38839505&dopt=Abstract false true Keyword 20121 /api/keyword/20121 true 20121 true Keyword 1153089 /api/keyword/1153089 true 1153089 true Keyword 1453506 /api/keyword/1453506 true 1453506 true Keyword 1655239 /api/keyword/1655239 true true SjrRating 11505753 /api/sjrrating/11505753 6 0.1 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2748 /api/classificationexternal/2748 true 2748 true D1 DIRECT true true /api/publication/34971900 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Sternberg Cora N </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Loriot Yohann </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Choy Ernest </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Castellano Daniel </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lopez-Rios Fernando </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Banna Giuseppe Luigi </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Zengerling Friedemann </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >De Giorgi Ugo </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Gedye Craig </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Masini Cristina </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Bamias Aristotelis </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Garcia Del Muro Xavier </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Duran Ignacio </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Powles Thomas </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Retz Margitta </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Gamulin Marija </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10034949"><a href="/gui2/?type=authors&mode=browse&sel=10034949" target="_blank">Geczi Lajos (<span class="authorship-author-name">Géczi Lajos</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Huddart Robert A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Calabrò Fabio </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kandula Geetha </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Skamnioti Pari </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Merseburger Axel S </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;34971900" target="_blank">Final Results from SAUL, a Single-arm International Study of Atezolizumab in Unselected Patients with Pretreated Locally Advanced/Metastatic Urinary Tract Carcinoma</a></div> <div> <span class="journal-title">EUROPEAN UROLOGY FOCUS</span> <span class="journal-issn">( <a target="_blank" href="https://portal.issn.org/resource/ISSN/2405-4569">2405-4569</a>)</span>: <span class="journal-volume">10</span> <span class="journal-issue">6</span> <span class="page"> pp 938-946 </span> <span class="year">(2024)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1016/j.euf.2024.05.007" target="_blank" href="https://doi.org/10.1016/j.euf.2024.05.007"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="001430411200001" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/001430411200001"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85195024302" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85195024302"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="38839505" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=38839505&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Urology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 2</span> | Független: 2 | Függő: 0 | Nem jelölt: 0 | WoS jelölt: 2 | Scopus jelölt:&nbsp;1 | WoS/Scopus jelölt:&nbsp;2 | DOI jelölt:&nbsp;2 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;34971900&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 2 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 34971900</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2025.04.07. 12:12 Háromszéki-Virág Fruzsina (MTMT Központi admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Export Date: 14 January 2025 Correspondence Address: Sternberg, C.N.; Englander Institute for Precision Medicine, 413 East 69th Street, United States; email: cns9006@med.cornell.edu</pre> </div></div> JournalArticle 34827132 VALIDATED true Royal Cornwall Hospital, Treliske, Truro, United Kingdom AOU delle Marche, Università Politecnica delle Marche, Ancona, Italy Instituto Valenciano de Oncología, Valencia, Spain Kingston Health Sciences Centre, Kingston, ON, Canada NU Cancer, Newcastle University, Newcastle upon Tyne, United Kingdom St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia Sarah Cannon Research Institute, HCA Healthcare, London, United Kingdom National Institute of Oncology, Budapest, Hungary Clinic Institute of Hematological and Oncological Diseases, Hospital Clinic, Barcelona, Spain Hospital Universitario 12 de Octubre, Madrid, Spain Weston Park Hospital, University of Sheffield, Sheffield, United Kingdom General University Hospital in Prague, Prague, Czech Republic IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori,”, Meldola, Italy Pfizer, San Francisco, CA, United States Pfizer, San Diego, CA, United States Pfizer, New York, NY, United States Pfizer, Paris, France Pfizer, Milan, Italy Fundación Jiménez Díaz University Hospital, Madrid, Spain Export Date: 15 January 2025 Correspondence Address: Wheatley, D.A.; Royal Cornwall Hospital, Treliske, United Kingdom; email: duncanwheatley@nhs.net Chemicals/CAS: avelumab, 1537032-82-8; carboplatin, 41575-94-4; cisplatin, 15663-27-1, 26035-31-4, 96081-74-2; doxecitine, 951-77-9, 56905-41-0; gemcitabine, 103882-84-4, 95058-81-4; pemetrexed, 137281-23-3, 150399-23-8, 357166-30-4, 357166-29-1; Antibodies, Monoclonal, Humanized; avelumab; Carboplatin; Cisplatin; Deoxycytidine; Gemcitabine; Pemetrexed 0 false 2026-01-01T16:31:54.270+0000 2025-01-15T13:48:13.623+0000 2024-04-30T05:52:35.992+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true 2025-03-20T09:39:42.369+0000 2025-01-15T13:48:13.789+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true 2025-03-13T00:09:46.701+0000 true 521 Szuper Admin /api/admin/521 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Wheatley, Duncan A First-line avelumab plus chemotherapy in patients with advanced solid tumors results from the phase 1b/2 JAVELIN Chemotherapy Medley study. true true /api/journal/20113812 REVIEWED true false false 20113812 true 2767-9764 Journal FOREIGN 4 6 1609 1619 1609 11 2024 Chemotherapy can potentially enhance the activity of immune checkpoint inhibitors by promoting immune priming. The phase 1b/2 JAVELIN Chemotherapy Medley trial evaluated first-line avelumab + concurrent chemotherapy in patients with advanced urothelial carcinoma or nonsmall cell lung cancer (NSCLC).Avelumab 800 mg or 1200 mg was administered continuously every 3 weeks (Q3W) with standard doses of cisplatin + gemcitabine in patients with urothelial carcinoma, or carboplatin + pemetrexed in patients with nonsquamous NSCLC. Dual primary endpoints were dose-limiting toxicity (DLT; phase 1b) and confirmed objective response (phase 1b/2).In phase 1b, urothelial carcinoma and NSCLC cohorts received avelumab 800 mg (n=13 and n=6, respectively) or 1200 mg (n=6 each) + chemotherapy. In evaluable patients with urothelial carcinoma treated with avelumab 800 mg or 1200 mg + chemotherapy, DLT occurred in 1/12 (8.3%) and 1/6 (16.7%), respectively; no DLT occurred in the NSCLC cohort. In phase 2, 35 additional patients with urothelial carcinoma received avelumab 1200 mg + chemotherapy. Across all treated patients, safety profiles were similar irrespective of avelumab dose. Objective response rates (95% confidence internal) with avelumab 800 mg or 1200 mg + chemotherapy, respectively, across phase 1b/2, were 53.8% (25.1-80.8) and 39.0% (24.2-55.5) in urothelial carcinoma, and 50.0% (11.8-88.2) and 33.3% (4.3-77.7) in NSCLC.Preliminary efficacy and safety findings with avelumab + chemotherapy in urothelial carcinoma and NSCLC were consistent with previous studies of similar combination regimens. 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src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Wheatley Duncan A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Berardi Rossana </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Climent Duran Miguel A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Tomiak Anna </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Greystoke Alastair P </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Joshua Anthony M </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Arkenau Hendrik-Tobias </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10034949"><a href="/gui2/?type=authors&mode=browse&sel=10034949" target="_blank">Géczi Lajos (<span class="authorship-author-name">Géczi Lajos</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Garcia-Corbacho Javier </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Paz-Ares Luis G </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hussain Syed A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Petruželka Lubos </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Delmonte Angelo </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Chappey Colombe </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Masters Joanna C </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Michelon Elisabete </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Murphy Danielle A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Mwewa Sandrine </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Cesari Rossano </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Doger de Speville Bernard </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;34827132" target="_blank">First-line avelumab plus chemotherapy in patients with advanced solid tumors : results from the phase 1b/2 JAVELIN Chemotherapy Medley study..</a></div> <div> <span class="journal-title">CANCER RESEARCH COMMUNICATIONS</span> <span class="journal-issn">( <a target="_blank" href="https://portal.issn.org/resource/ISSN/2767-9764">2767-9764</a>)</span>: <span class="journal-volume">4</span> <span class="journal-issue">6</span> <span class="page"> pp 1609-1619 </span> <span class="year">(2024)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1158/2767-9764.CRC-23-0459" target="_blank" href="https://doi.org/10.1158/2767-9764.CRC-23-0459"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="001321759000003" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/001321759000003"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85197353854" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85197353854"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="38669053" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=38669053&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;Q1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Cancer Research&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;Q2</div> </div></OnlyViewableByAuthor> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;34827132&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 4 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 34827132</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2025.01.15. 14:48 Nádas Orsolya (OOI admin4) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Royal Cornwall Hospital, Treliske, Truro, United Kingdom AOU delle Marche, Università Politecnica delle Marche, Ancona, Italy Instituto Valenciano de Oncología, Valencia, Spain Kingston Health Sciences Centre, Kingston, ON, Canada NU Cancer, Newcastle University, Newcastle upon Tyne, United Kingdom ...</pre> </div></div> JournalArticle 32779816 VALIDATED true 0 false 2026-01-12T13:21:28.712+0000 2026-01-12T13:19:32.538+0000 2022-04-11T13:58:23.765+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true 2026-01-12T13:19:32.551+0000 2026-01-12T13:19:32.551+0000 2024-12-17T07:53:02.992+0000 true 10097128 Sass Dávid /api/admin/10097128 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Dieckmann, Klaus-Peter Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1 outcome, safety, and risk factors for relapse in a population-based study. true true /api/journal/10044613 REVIEWED true false 10044613 false 10044613 true 1758-8340 1758-8359 Journal FOREIGN 14 17588359221086813 17588359221086813 13 2022 Clinical stage 1 (CS1) nonseminomatous (NS) germ cell tumors involve a 30% probability of relapse upon surveillance. Adjuvant chemotherapy with one course of bleomycin, etoposide, and cisplatin (1xBEP) can reduce this risk to <5%. However, 1xBEP results are based solely on five controlled trials from high-volume centers. We analyzed the outcome in a real-life population.In a multicentric international study, 423 NS CS1 patients receiving 1xBEP were retrospectively evaluated. Median follow-up was 37 (range, 6-89) months. Primary end points were relapse-free and overall survival evaluated after 5 years. We also looked at associations of relapse with clinico-pathological factors using stratified Kaplan-Meier methods and Cox regression models. Treatment modality and outcome of recurrences were analyzed descriptively.The 5-year relapse-free survival rate was 96.2%. Thirteen patients (3.1%; 95% confidence interval, 1.65-5.04%) relapsed after a median time of 13 months, of which 10 were salvaged (77%). Relapses were mostly confined to retroperitoneal nodes. Three patients succumbed, two to disease progression and one to toxicity of chemotherapy. Pathological stage >pT2 was significantly associated with relapse rate.The relapse rate of 3.1% found in this population of NS CS1 patients treated with 1xBEP at the routine care level was not inferior to the median rate of 2.3% reported from a meta-analysis of controlled trials. Also, the cure rate of relapses of 77% is consistent with the previously reported rate of 80%. This study clearly shows that the 1xBEP regimen represents a safe treatment for NS CS1 patients. true 2022 true true true false true false NONE 2026-01-12 false 6 0 6 5 0 6 6 5 4 6 6 5 5 5 1 0 6 5 6 5 0 0 0 Q1 false 10034949 false false false 2022-07-10T13:58:42.413+0000 Országos Onkológiai Intézet; Széchenyi István Egyetem 2 17 2 37 0 true Language 10002 /api/language/10002 Angol English true 2 true PersonAuthorship 101331710 /api/authorship/101331710 1 0.0 true false false Dieckmann Klaus-Peter true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 101331711 /api/authorship/101331711 2 0.0 false false false Pokrivcak Tomas true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true PersonAuthorship 101331712 /api/authorship/101331712 3 0.0 false false false Author 10034949 /api/author/10034949 Géczi Lajos true 10034949 true Geczi Lajos true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false true 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RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2730 /api/classificationexternal/2730 true 2730 true Q1 DIRECT true true /api/publication/32779816 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <div class="autype autype0"> <span class="author-name" >Dieckmann Klaus-Peter </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10034949"><a href="/gui2/?type=authors&mode=browse&sel=10034949" target="_blank">Geczi Lajos (<span class="authorship-author-name">Géczi Lajos</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10024777"><a href="/gui2/?type=authors&mode=browse&sel=10024777" target="_blank">Törzsök Péter (<span class="authorship-author-name">Törzsök Péter</span> <span class="authorAux-mtmt"> Urológia</span>) </a> </span> <span class="author-affil">Széchenyi István Egyetem</span> ;&nbsp;&nbsp;&nbsp; et al. (37) </div> <div><a target="_blank" href="/api/publication/32779816?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;32779816" target="_blank">Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1 : outcome, safety, and risk factors for relapse in a population-based study..</a></div> <div> <span class="journal-title">THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/1758-8340">1758-8340</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1758-8359">1758-8359</a>)</span>: <span class="journal-volume">14</span> <span class="page"> Paper 17588359221086813. 13 p. </span> <span class="year">(2022)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1177/17588359221086813" target="_blank" href="https://doi.org/10.1177/17588359221086813"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000778006500001" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000778006500001"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85128751466" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85128751466"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="35386956" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=35386956&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;Q1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 6</span> | Független: 5 | Függő: 1 | Nem jelölt: 0 | WoS jelölt: 5 | Scopus jelölt:&nbsp;4 | WoS/Scopus jelölt:&nbsp;6 | DOI jelölt:&nbsp;6 </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 32779816</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2026.01.12. 14:19 Pirmann Tamás (OOI admin4) </div> </div></div> JournalArticle 32044069 VALIDATED true Funding Agency and Grant Number: Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, NJ, USA Funding text: Funding Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, NJ, USA. 0 false 2026-03-10T07:52:40.659+0000 2022-04-06T09:26:16.191+0000 2021-05-31T13:13:49.417+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true 2025-01-14T15:16:39.590+0000 2022-01-10T13:53:17.058+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true 2022-01-19T11:16:09.750+0000 true 10015544 Csajbók Edit /api/admin/10015544 Admin true 10015544 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Powles, Thomas Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361) a randomised, open-label, phase 3 trial true true /api/journal/10001287 REVIEWED true false 10001287 false 10001287 true 1470-2045 1474-5488 Journal FOREIGN 22 7 931 945 931 15 2021 PD-1 and PD-L1 inhibitors are active in metastatic urothelial carcinoma, but positive randomised data supporting their use as a first-line treatment are lacking. In this study we assessed outcomes with first-line pembrolizumab alone or combined with chemotherapy versus chemotherapy for patients with previously untreated advanced urothelial carcinoma.KEYNOTE-361 is a randomised, open-label, phase 3 trial of patients aged at least 18 years, with untreated, locally advanced, unresectable, or metastatic urothelial carcinoma, with an Eastern Cooperative Oncology Group performance status of up to 2. Eligible patients were enrolled from 201 medical centres in 21 countries and randomly allocated (1:1:1) via an interactive voice-web response system to intravenous pembrolizumab 200 mg every 3 weeks for a maximum of 35 cycles plus intravenous chemotherapy (gemcitabine [1000 mg/m2] on days 1 and 8 and investigator's choice of cisplatin [70 mg/m2] or carboplatin [area under the curve 5] on day 1 of every 3-week cycle) for a maximum of six cycles, pembrolizumab alone, or chemotherapy alone, stratified by choice of platinum therapy and PD-L1 combined positive score (CPS). Neither patients nor investigators were masked to the treatment assignment or CPS. At protocol-specified final analysis, sequential hypothesis testing began with superiority of pembrolizumab plus chemotherapy versus chemotherapy alone in the total population (all patients randomly allocated to a treatment) for the dual primary endpoints of progression-free survival (p value boundary 0·0019), assessed by masked, independent central review, and overall survival (p value boundary 0·0142), followed by non-inferiority and superiority of overall survival for pembrolizumab versus chemotherapy in the patient population with CPS of at least 10 and in the total population (also a primary endpoint). Safety was assessed in the as-treated population (all patients who received at least one dose of study treatment). This study is completed and is no longer enrolling patients, and is registered at ClinicalTrials.gov, number NCT02853305.Between Oct 19, 2016 and June 29, 2018, 1010 patients were enrolled and allocated to receive pembrolizumab plus chemotherapy (n=351), pembrolizumab monotherapy (n=307), or chemotherapy alone (n=352). Median follow-up was 31·7 months (IQR 27·7-36·0). Pembrolizumab plus chemotherapy versus chemotherapy did not significantly improve progression-free survival, with a median progression-free survival of 8·3 months (95% CI 7·5-8·5) in the pembrolizumab plus chemotherapy group versus 7·1 months (6·4-7·9) in the chemotherapy group (hazard ratio [HR] 0·78, 95% CI 0·65-0·93; p=0·0033), or overall survival, with a median overall survival of 17·0 months (14·5-19·5) in the pembrolizumab plus chemotherapy group versus 14·3 months (12·3-16·7) in the chemotherapy group (0·86, 0·72-1·02; p=0·0407). No further formal statistical hypothesis testing was done. In analyses of overall survival with pembrolizumab versus chemotherapy (now exploratory based on hierarchical statistical testing), overall survival was similar between these treatment groups, both in the total population (15·6 months [95% CI 12·1-17·9] with pembrolizumab vs 14·3 months [12·3-16·7] with chemotherapy; HR 0·92, 95% CI 0·77-1·11) and the population with CPS of at least 10 (16·1 months [13·6-19·9] with pembrolizumab vs 15·2 months [11·6-23·3] with chemotherapy; 1·01, 0·77-1·32). The most common grade 3 or 4 adverse event attributed to study treatment was anaemia with pembrolizumab plus chemotherapy (104 [30%] of 349 patients) or chemotherapy alone (112 [33%] of 342 patients), and diarrhoea, fatigue, and hyponatraemia (each affecting four [1%] of 302 patients) with pembrolizumab alone. Six (1%) of 1010 patients died due to an adverse event attributed to study treatment; two patients in each treatment group. One each occurred due to cardiac arrest and device-related sepsis in the pembrolizumab plus chemotherapy group, one each due to cardiac failure and malignant neoplasm progression in the pembrolizumab group, and one each due to myocardial infarction and ischaemic colitis in the chemotherapy group.The addition of pembrolizumab to first-line platinum-based chemotherapy did not significantly improve efficacy and should not be widely adopted for treatment of advanced urothelial carcinoma.Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, NJ, USA. true true 2021 true true true false true false NONE 2026-03-10 false 553 0 553 450 7 550 544 513 472 553 553 450 450 450 103 0 553 450 553 450 0 1 1 D1 false 10034949 false false false 2021-08-29T13:14:03.489+0000 Országos Onkológiai Intézet 3 14 1 20 238 true Language 10002 /api/language/10002 Angol English true 2 true OrgAuthorship 96461246 /api/authorship/96461246 0 0.0 false false false true false false AuthorshipType 30 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target="_blank">Bodoky Gyorgy (<span class="authorship-author-name">Bodoky György</span> <span class="authorAux-mtmt"> Onkológia, sebészet, gastroenterológia</span>) </a> </span> ;&nbsp;&nbsp;&nbsp; et al. (238) </div> <div class="autype autype-29"> Kollaborációs szervezet: <span class="author-affil">KEYNOTE-361 Investigators</span> </div> <div><a target="_blank" href="/api/publication/32044069?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;32044069" target="_blank">Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361) : a randomised, open-label, phase 3 trial.</a></div> <div> <span class="journal-title">LANCET ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/1470-2045">1470-2045</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-5488">1474-5488</a>)</span>: <span class="journal-volume">22</span> <span class="journal-issue">7</span> <span class="page"> pp 931-945 </span> <span class="year">(2021)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1016/S1470-2045(21)00152-2" target="_blank" href="https://doi.org/10.1016/S1470-2045%2821%2900152-2"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000668269600039" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000668269600039"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85108821894" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85108821894"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="34051178" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=34051178&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 553</span> | Független: 450 | Függő: 103 | Nem jelölt: 0 | WoS jelölt: 513 | Scopus jelölt:&nbsp;472 | WoS/Scopus jelölt:&nbsp;553 | DOI jelölt:&nbsp;544 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;32044069&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 32044069</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2022.04.06. 11:26 Bodoky György (Onkológia, sebészet, gastroenterológia) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Funding Agency and Grant Number: Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, NJ, USA Funding text: Funding Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, NJ, USA.</pre> </div></div> JournalArticle 30719909 ADMIN_APPROVED true 0 false 2026-02-19T08:35:16.758+0000 2019-07-15T07:19:39.472+0000 2019-06-24T07:05:27.261+0000 true 10055596 Faragó Dániel /api/admin/10055596 Admin true 10055596 2021-12-28T11:01:39.082+0000 2021-12-28T11:01:39.082+0000 2019-06-24T07:05:44.652+0000 true 10055596 Faragó Dániel /api/admin/10055596 Admin true 10055596 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 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(39) </div> <div><a target="_blank" href="/api/publication/30719909?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;30719909" target="_blank">Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study</a></div> <div> <span class="journal-title">JOURNAL OF CLINICAL ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0732-183X">0732-183X</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1527-7755">1527-7755</a>)</span>: <span class="journal-volume">37</span> <span class="journal-issue">16</span> <span class="page"> pp 1412-1423 </span> <span class="year">(2019)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_PAY" title=" Fizetős "> <a style="color:blue" title="10.1200/JCO.18.01480" target="_blank" href="https://doi.org/10.1200/JCO.18.01480"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000471946600007" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000471946600007"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="30875280" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=30875280&dopt=Abstract"> PubMed </a> </span> <span class="id identifier oa_PAY" title=" Fizetős "> <a style="color:blue" title="https://ascopubs.org/doi/10.1200/JCO.18.01480" target="_blank" href="https://ascopubs.org/doi/10.1200/JCO.18.01480"> Egyéb URL </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Cancer Research&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Medicine (miscellaneous)&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 262</span> | Független: 209 | Függő: 53 | Nem jelölt: 0 | WoS jelölt: 262 | Scopus jelölt:&nbsp;135 | WoS/Scopus jelölt:&nbsp;262 | DOI jelölt:&nbsp;257 </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 30719909</span> | <span class="status-data status-ADMIN_APPROVED"> Admin láttamozott </span> Forrás | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">DOI XML</span> </div> <div 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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=28916371&dopt=Abstract false 1675729 true Classification 12548 /api/classification/12548 true true Classification 12215 /api/classification/12215 true true MtaRating 11507983 /api/mtarating/11507983 RatingType 10011 /api/ratingtype/10011 DEM Institute 19060 /api/institute/19060 0 false true false Demográfiai Osztályközi Állandó Bizottság Committee on Demography true 19060 true true true A nemzetközi false true MtaRating 519059 /api/mtarating/519059 RatingType 10007 /api/ratingtype/10007 SZTB Institute 14102 /api/institute/14102 0 false true false Szociológiai Tudományos Bizottság Committee on Sociology true 14102 true true true A nemzetközi true 19059 true SjrRating 10971853 /api/sjrrating/10971853 7 0.0 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2701 /api/classificationexternal/2701 true 2701 true D1 DIRECT true true /api/publication/3297518 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Petrylak DP ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10034949"><a href="/gui2/?type=authors&mode=browse&sel=10034949" target="_blank">Géczi L (<span class="authorship-author-name">Géczi Lajos</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; et al. (39) </div> <div class="autype autype-11"> Kollaborációs közreműködő: <span class="author-name" >Suet-Lai Shirley Wong </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10061834"><a href="/gui2/?type=authors&mode=browse&sel=10061834" target="_blank">Révész Janos (<span class="authorship-author-name">Révész János</span> <span class="authorAux-mtmt"> Orvostudomány, onkológia</span>) </a> </span> ;&nbsp;&nbsp;&nbsp; et al. (129) </div> <div class="autype autype-29"> Kollaborációs szervezet: <span class="author-affil">RANGE Study Investigators</span> </div> <div><a target="_blank" href="/api/publication/3297518?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;3297518" target="_blank">Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial</a></div> <div> <span class="journal-title">LANCET</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0140-6736">0140-6736</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-547X">1474-547X</a>)</span>: <span class="journal-volume">390</span> <span class="journal-issue">10109</span> <span class="page"> pp 2266-2277 </span> <span class="year">(2017)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_PAY" title=" Fizetős "> <a style="color:blue" title="10.1016/S0140-6736(17)32365-6" target="_blank" href="https://doi.org/10.1016/S0140-6736%2817%2932365-6"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000415645700025" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000415645700025"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85029228806" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85029228806"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="28916371" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=28916371&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Medicine (miscellaneous)&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Demográfiai Osztályközi Állandó Bizottság IXGJO DEM [1901-]&nbsp;&nbsp;&nbsp;A nemzetközi</div> <div class="journal-subject">Szociológiai Tudományos Bizottság IXGJO SZTB [1901-]&nbsp;&nbsp;&nbsp;A nemzetközi</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 154</span> | Független: 122 | Függő: 32 | Nem jelölt: 0 | WoS jelölt: 139 | Scopus jelölt:&nbsp;147 | WoS/Scopus jelölt:&nbsp;154 | DOI jelölt:&nbsp;146 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;3297518&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 3297518</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> <span class="oldId">Régi azonosító: 3297518</span> | Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2023.04.14. 13:02 Belházyné Szombathelyi Ágnes (SZTE admin5) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Author worked as RANGE study investigators.</pre> </div></div> JournalArticle 3004045 ADMIN_APPROVED true CN METEOR Investigators 0 2017-11-29T09:28:06.000+0000 false 3004045 2026-03-18T10:51:25.834+0000 2023-05-22T09:59:57.751+0000 2016-01-22T11:08:08.000+0000 true 10034949 Géczi Lajos /api/author/10034949 Author true 10034949 2023-05-22T09:59:58.551+0000 2023-05-22T09:59:58.551+0000 2019-08-01T09:12:47.797+0000 true 10055596 Faragó Dániel /api/admin/10055596 Admin true 10055596 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Choueiri, TK Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. true true /api/journal/1394667 REVIEWED true false 1394667 false 1394667 true 0028-4793 1533-4406 Journal FOREIGN 373 19 1814 1823 1814 10 2015 BACKGROUND: Cabozantinib is an oral, small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR) as well as MET and AXL, each of which has been implicated in the pathobiology of metastatic renal-cell carcinoma or in the development of resistance to antiangiogenic drugs. This randomized, open-label, phase 3 trial evaluated the efficacy of cabozantinib, as compared with everolimus, in patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. METHODS: We randomly assigned 658 patients to receive cabozantinib at a dose of 60 mg daily or everolimus at a dose of 10 mg daily. The primary end point was progression-free survival. Secondary efficacy end points were overall survival and objective response rate. RESULTS: Median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus. The rate of progression or death was 42% lower with cabozantinib than with everolimus (hazard ratio, 0.58; 95% confidence interval [CI] 0.45 to 0.75; P<0.001). The objective response rate was 21% with cabozantinib and 5% with everolimus (P<0.001). A planned interim analysis showed that overall survival was longer with cabozantinib than with everolimus (hazard ratio for death, 0.67; 95% CI, 0.51 to 0.89; P=0.005) but did not cross the significance boundary for the interim analysis. Adverse events were managed with dose reductions; doses were reduced in 60% of the patients who received cabozantinib and in 25% of those who received everolimus. Discontinuation of study treatment owing to adverse events occurred in 9% of the patients who received cabozantinib and in 10% of those who received everolimus. CONCLUSIONS: Progression-free survival was longer with cabozantinib than with everolimus among patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. 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/api/keyword/1040595 true 1040595 true Keyword 1060754 /api/keyword/1060754 true 1060754 true Keyword 1257483 /api/keyword/1257483 true 1257483 true Keyword 1392912 /api/keyword/1392912 true 1392912 true Keyword 1392913 /api/keyword/1392913 true 1392913 true Keyword 1392914 /api/keyword/1392914 true 1392914 true Keyword 1392915 /api/keyword/1392915 true 1392915 true SjrRating 11037552 /api/sjrrating/11037552 6 0.0 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2701 /api/classificationexternal/2701 true 2701 true D1 DIRECT true true /api/publication/3004045 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <div class="autype autype0"> <span class="author-name" >Choueiri TK </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Escudier B </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Powles T </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Mainwaring PN </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Rini BI </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Donskov F </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hammers H </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hutson TE </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lee JL </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Peltola K </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Roth BJ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Bjarnason GA </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10034949"><a href="/gui2/?type=authors&mode=browse&sel=10034949" target="_blank">Geczi L (<span class="authorship-author-name">Géczi Lajos</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Keam B </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Maroto P </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Heng DY </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Schmidinger M </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kantoff PW </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Borgman-Hagey A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hessel C </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Scheffold C </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Schwab GM </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Tannir NM </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Motzer RJ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >METEOR Investigators </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;3004045" target="_blank">Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma.</a></div> <div> <span class="journal-title">NEW ENGLAND JOURNAL OF MEDICINE</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0028-4793">0028-4793</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1533-4406">1533-4406</a>)</span>: <span class="journal-volume">373</span> <span class="journal-issue">19</span> <span class="page"> pp 1814-1823 </span> <span class="year">(2015)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1056/NEJMoa1510016" target="_blank" href="https://doi.org/10.1056/NEJMoa1510016"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000364144000005" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000364144000005"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="84946552683" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-84946552683"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="26406150" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=26406150&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Medicine (miscellaneous)&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 1,125</span> | Független: 934 | Függő: 191 | Nem jelölt: 0 | WoS jelölt: 1,013 | Scopus jelölt:&nbsp;1,035 | WoS/Scopus jelölt:&nbsp;1,122 | DOI jelölt:&nbsp;1,072 </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 3004045</span> | <span class="status-data status-ADMIN_APPROVED"> Admin láttamozott </span> <span class="oldId">Régi azonosító: 3004045</span> | Forrás | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">MEDLINE</span> </div> <div class="lastModified">Utolsó módosítás: 2023.05.22. 11:59 Pirmann Tamás (OOI addmin5, admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: CN METEOR Investigators</pre> </div></div> JournalArticle 3004055 ADMIN_APPROVED true CA Abiraterone Global EAP Investigat 0 2016-01-22T11:20:29.000+0000 false 3004055 2026-01-12T13:08:49.281+0000 2026-01-12T13:05:29.642+0000 2016-01-22T11:14:54.000+0000 true 10034949 Géczi Lajos /api/author/10034949 Author true 10034949 2026-01-12T13:05:29.655+0000 2026-01-12T13:05:29.655+0000 2025-01-14T13:48:27.743+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Sternberg, CN Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial true true /api/journal/10001287 REVIEWED true false 10001287 false 10001287 true 1470-2045 1474-5488 Journal FOREIGN 15 11 1263 1268 1263 6 2014 Background In the final analysis of the phase 3 COU-AA-301 study, abiraterone acetate plus prednisone significantly prolonged overall survival compared with prednisone alone in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy. Here, we present the final analysis of an early-access protocol trial that was initiated after completion of COU-AA-301 to enable worldwide preapproval access to abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy. Methods We did a multicentre, open-label, early-access protocol trial in 23 countries. We enrolled patients who had metastatic castration-resistant prostate cancer progressing after taxane chemotherapy. Participants received oral doses of abiraterone acetate (1000 mg daily) and prednisone (5 mg twice a day) in 28-day cycles until disease progression, development of sustained side-effects, or abiraterone acetate becoming available in the respective country. The primary outcome was the number of adverse events arising during study treatment and within 30 days of discontinuation. Efficacy measures (time to prostate-specific antigen [PSA] progression and time to clinical progression) were gathered to guide treatment decisions. We included in our analysis all patients who received at least one dose of abiraterone acetate. This study is registered with ClinicalTrials.gov, number NCT01217697. Findings Between Nov 17, 2010, and Sept 30, 2013, 2314 patients were enrolled into the early-access protocol trial. Median follow-up was 5.7 months (IQR 3.5-10.6). 952 (41%) patients had a grade 3 or 4 treatment-related adverse event, and grade 3 or 4 serious adverse events were recorded in 585 (25%) people. The most common grade 3 and 4 adverse events were hepatotoxicity (188 [8%]), hypertension (99 [4%]), cardiac disorders (52 [2%]), osteoporosis (31 [1%]), hypokalaemia (28 [1%]), and fluid retention or oedema (23 [1%]). 172 (7%) patients discontinued the study because of adverse events (64 [3%] were drug-related), as assessed by the investigator, and 171 (7%) people died. The funder assessed causes of death, which were due to disease progression (85 [4%]), an unrelated adverse experience (72 [3%]), and unknown reasons (14 [1%]). Of the 86 deaths not attributable to disease progression, 18 (<1%) were caused by a drug-related adverse event, as assessed by the investigator. Median time to PSA progression was 8.5 months (95% CI 8.3-9.7) and median time to clinical progression was 12.7 months (11.8-13.8). Interpretation No new safety signals or unexpected adverse events were found in this early-access protocol trial to assess abiraterone acetate for patients with metastatic castration-resistant prostate cancer who progressed after chemotherapy. Future work is needed to ascertain the most eff ective regimen of abiraterone acetate to optimise patients' outcomes. 2016 (Géczi Lajos (Onkológia); 2016.01.22. 12:14:33) true true true false true false NONE 2026-01-12 false true 10034949 Géczi Lajos /api/author/10034949 Author true 10034949 50 0 50 44 1 49 44 45 44 50 50 44 44 44 6 0 50 44 50 44 0 0 0 D1 false 10034949 false false false 2016-04-21T10:20:29.000+0000 2016-01-22T11:20:29.000+0000 Országos Onkológiai Intézet 1 5 1 20 0 true Language 10002 /api/language/10002 Angol English true 2 true PersonAuthorship 7272569 /api/authorship/7272569 1 0.05 true false Sternberg CN true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 23279258 true PersonAuthorship 7272570 /api/authorship/7272570 2 0.05 false false Castellano D true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 23279257 true PersonAuthorship 7272571 /api/authorship/7272571 3 0.05 false false Daugaard G true false false 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/api/publication/3004055 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <div class="autype autype0"> <span class="author-name" >Sternberg CN </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Castellano D </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Daugaard G </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10034949"><a href="/gui2/?type=authors&mode=browse&sel=10034949" target="_blank">Geczi L (<span class="authorship-author-name">Géczi Lajos</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hotte SJ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Mainwaring PN </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Saad F </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Souza C </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Tay MH </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Garrido JMT </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Galli L </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Londhe A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >De Porre P </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Goon B </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lee E </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >McGowan T </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Naini V </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Todd MB </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Molina A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >George DJ </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;3004055" target="_blank">Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial</a></div> <div> <span class="journal-title">LANCET ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/1470-2045">1470-2045</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-5488">1474-5488</a>)</span>: <span class="journal-volume">15</span> <span class="journal-issue">11</span> <span class="page"> pp 1263-1268 </span> <span class="year">(2014)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1016/S1470-2045(14)70417-6" target="_blank" href="https://doi.org/10.1016/S1470-2045%2814%2970417-6"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000343096800052" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000343096800052"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="84908125722" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-84908125722"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="25242048" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=25242048&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 50</span> | Független: 44 | Függő: 6 | Nem jelölt: 0 | WoS jelölt: 45 | Scopus jelölt:&nbsp;44 | WoS/Scopus jelölt:&nbsp;50 | DOI jelölt:&nbsp;44 </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 3004055</span> | <span class="status-data status-ADMIN_APPROVED"> Admin láttamozott </span> <span class="oldId">Régi azonosító: 3004055</span> | Forrás | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">WOS</span> </div> <div class="lastModified">Utolsó módosítás: 2026.01.12. 14:05 Pirmann Tamás (OOI admin4) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: CA Abiraterone Global EAP Investigat</pre> </div></div>