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Global real-world experiences with pembrolizumab in advanced urothelial carcinoma after platinum-based chemotherapy: the ARON-2 study
F. Massari, M. Santoni, H. Takeshita, Y. Okada, JC. Tapia, U. Basso, M. Maruzzo, S. Scagliarini, T. Büttner, G. Fornarini, ZW. Myint, L. Galli, VC. Souza, R. Pichler, U. De Giorgi, N. Gandur, ET. Lam, D. Gilbert, L. Popovic, E. Grande, G....
Jazyk angličtina Země Německo
Typ dokumentu klinická studie, časopisecké články
NLK
Directory of Open Access Journals
od 2024
PubMed Central
od 1982
ProQuest Central
od 1997-03-01 do Před 1 rokem
Medline Complete (EBSCOhost)
od 2000-04-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 1997-03-01 do Před 1 rokem
Public Health Database (ProQuest)
od 1997-03-01 do Před 1 rokem
Springer Journals Complete - Open Access
od 2024-01-01
Springer Nature OA/Free Journals
od 2024-01-01
- MeSH
- adjuvancia imunologická MeSH
- humanizované monoklonální protilátky * MeSH
- karcinom z přechodných buněk * MeSH
- lidé MeSH
- nádory močového měchýře * MeSH
- platina MeSH
- retrospektivní studie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinická studie MeSH
BACKGROUND: Immune checkpoint inhibitors have changed previous treatment paradigm of advanced urothelial carcinoma (UC). The ARON-2 study (NCT05290038) aimed to assess the real-world effectiveness of pembrolizumab in patients recurred or progressed after platinum-based chemotherapy. PATIENTS AND METHODS: Medical records of patients with documented metastatic UC treated by pembrolizumab as second-line therapy were retrospectively collected from 88 institutions in 23 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS) and overall response rate (ORR). Cox proportional hazards models were adopted to explore the presence of prognostic factors. RESULTS: In total, 836 patients were included: 544 patients (65%) received pembrolizumab after progression to first-line platinum-based chemotherapy in the metastatic setting (cohort A) and 292 (35%) after recurring within < 12 months since the completion of adjuvant or neoadjuvant chemotherapy (cohort B). The median follow-up time was 15.3 months. The median OS and the ORR were 10.5 months and 31% in the overall study population, 9.1 months and 29% in cohort A and 14.6 months and 37% in cohort B. At multivariate analysis, ECOG-PS ≥ 2, bone metastases, liver metastases and pembrolizumab setting (cohort A vs B) proved to be significantly associated with worst OS and PFS. Stratified by the presence of 0, 1-2 or 3-4 prognostic factors, the median OS was 29.4, 12.5 and 4.1 months (p < 0.001), while the median PFS was 12.2, 6.4 and 2.8 months, respectively (p < 0.001). CONCLUSIONS: Our study confirms that pembrolizumab is effective in the advanced UC real-world context, showing outcome differences between patients recurred or progressed after platinum-based chemotherapy.
ASLCN2 Alba Bra Ospedale Michele E Pietro Ferrero Verduno CN Italy
Centro de Pesquisas Oncológicas CEPON Florianópolis SC Brazil
Centro Oncologico Estatal Dr José Luis Barrera Franco del ISSEMYM Toluca de Lerdo Mexico
Chair of Oncology Interdisciplinary Department of Medicine University of Bari Aldo Moro Bari Italy
Clínica AMO Salvador BA Brazil
Clinica de Oncologia Clion Salvador BA Brazil
Clinica Medica Especializada en Oncologia Medica Guatemala City Guatemala
Clinical Oncology Sociedad de Oncología y Hematología del Cesar Valledupar Colombia
Clinicas Medicas Especializadas NUCARE Guatemala City Guatemala
Dana Farber Cancer Institute Harvard Medical School Boston MA USA
Department of Biomedical Sciences Humanitas University Pieve Emanuele Milan Italy
Department of Medical Oncology Centre Hospitalier de Jolimont Haine Saint Paul Belgium
Department of Medical Oncology Hospital Ramón y Cajal Madrid Spain
Department of Medical Oncology Maggiore Della Carità University Hospital 28100 Novara Italy
Department of Medical Oncology MD Anderson Cancer Center Madrid Madrid Spain
Department of Oncology Hospital Sírio Libanês São Paulo SP Brazil
Department of Oncology IRCCS Humanitas Research Hospital Rozzano Milan Italy
Department of Oncology San Camillo Forlanini Hospital Rome Italy
Department of Urology Medical University of Innsbruck Anichstrasse 35 6020 Innsbruck Austria
Department of Urology Saitama Medical Center Saitama Medical University Saitama Japan
Department of Urology University Hospital Bonn 53127 Bonn Germany
Dipartimento di Oncologia Medica Fondazione IRCCS Istituto Nazionale Dei Tumori Milan Italy
Division of Cancer Prevention and Genetics IEO European Institute of Oncology IRCCS Milan Italy
Fundacion Centro Oncologico de Integracion Regional COIR Mendoza Argentina
Hospital AC Camargo São Paulo SP Brazil
Hospital Angel Roffo Buenos Aires CABA Argentina
Hospital Beneficencia Portuguesa de São Paulo São Paulo SP Brazil
Hospital do Câncer Porto Dias Rede Mater Dei de Saúde Belém PA Brazil
Hospital Erasto Gaertner Curitiba PR Brazil
Hospital Israelita Albert Einstein São Paulo SP Brazil
Hospital Santa Casa de Sao Paulo São Paulo SP Brazil
Hospital São Rafael Oncologia D'Or Salvador BA Brazil
Hospital Sao Rafael Salvador BA Brazil
Hospital Sirio Libanês Brasília DF Brazil
Hospital Sirio Libanes Buenos Aires CABA Argentina
Instituto Alexander Fleming Buenos Aires CABA Argentina
Instituto D'Or de Ensino e Pesquisa Rio de Janeiro RJ Brazil
IRCCS Ospedale Policlinico San Martino Genoa Italy
Klinik für Urologie Ratzeburger Allee 160 23538 Lübeck Germany
Latin American Cooperative Oncology Group LACOG Porto Alegre Brazil
Markey Cancer Center University of Kentucky Lexington KY 40536 0293 USA
Medical Oncology 1 IRCCS Regina Elena National Cancer Institute Rome Italy
Medical Oncology Department La Paz University Hospital Madrid Spain
Medical Oncology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy
Medical Oncology Tawam Hospital Al Ain United Arab Emirates
Medical Oncology Unit Gemelli Molise Hospital Università Cattolica del Sacro Cuore Campobasso Italy
Medical Oncology Unit Santa Chiara Hospital Trento Italy
National Cancer Centre Singapore Singapore Singapore
Niguarda Cancer Center Grande Ospedale Metropolitano Niguarda Milan Italy
Oncologia D'Or Fortaleza CE Brazil
Oncologia Medica Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oncologia Medica Ospedale Maggiore di Cremona Cremona Italy
Oncology Candiolo Cancer Institute IRCCS FPO 10060 Turin Italy
Oncology Institute of Vojvodina Faculty of Medicine University Novi Sad Novi Sad Serbia
Oncology Unit 2 University Hospital of Pisa 56126 Pisa Italy
Oncology Unit A R N A S Civico Palermo Italy
Oncology Unit Macerata Hospital via Santa Lucia 2 62100 Macerata Italy
ONCOR Life Medical Center Saltillo Mexico
Pontificia Universidade Católica do Rio Grande do Sul PUCRS Porto Alegre RS Brazil
Southampton Experimental Cancer Medicine Centre University of Southampton Southampton UK
Unità di Oncologia Medica Azienda Ospedaliero Universitaria di Cagliari Cagliari Italy
Universidade Federal de Minas Gerais UFMG Belo Horizonte MG Brazil
University of Colorado Anschutz Medical Campus Aurora CO USA
University of Medicine and Pharmacy Bucharest Romania
UOC di Oncologia Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli Naples Italy
UOC Oncologia Azienda Ospedaliera Ospedali Riuniti Marche Nord Fano Italy
UOC Oncologia Medica Ospedale A Murri Fermo Italy
Urologic Oncology Champalimaud Clinical Center 1400 038 Lisbon Portugal
Citace poskytuje Crossref.org
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- $a Global real-world experiences with pembrolizumab in advanced urothelial carcinoma after platinum-based chemotherapy: the ARON-2 study / $c F. Massari, M. Santoni, H. Takeshita, Y. Okada, JC. Tapia, U. Basso, M. Maruzzo, S. Scagliarini, T. Büttner, G. Fornarini, ZW. Myint, L. Galli, VC. Souza, R. Pichler, U. De Giorgi, N. Gandur, ET. Lam, D. Gilbert, L. Popovic, E. Grande, G. Mammone, R. Berardi, SJ. Crabb, R. Kemp, J. Molina-Cerrillo, M. Freitas, M. Luz, R. Iacovelli, F. Calabrò, D. Tural, F. Atzori, Z. Küronya, R. Chiari, S. Campos, O. Caffo, AP. Fay, J. Kucharz, PA. Zucali, JA. Rinck, A. Zeppellini, DA. Bastos, G. Aurilio, A. Mota, K. Trindade, C. Ortega, JP. Sade, M. Rizzo, O. Fiala, N. Vau, P. Giannatempo, A. Barillas, FSM. Monteiro, B. Dauster, A. Mennitto, L. Nogueira, R. de Carvalho Fernandes, E. Seront, LG. Aceituno, F. Grillone, HJ. Cutuli, M. Fernandez, M. Bassanelli, RM. Kopp, G. Roviello, H. Abahssain, G. Procopio, M. Milella, J. Kopecky, A. Martignetti, C. Messina, M. Caitano, E. Inman, R. Kanesvaran, D. Herchhorn, D. Santini, A. Bamias, R. Bisonni, A. Mosca, F. Morelli, F. Maluf, A. Soares, F. Nunes, A. Pinto, A. Zgura, L. Incorvaia, J. Ansari, IO. Zabalza, J. Landmesser, A. Rizzo, V. Mollica, A. Marchetti, M. Rosellini, G. Sorgentoni, N. Battelli, S. Buti, C. Porta, J. Bellmunt
- 520 9_
- $a BACKGROUND: Immune checkpoint inhibitors have changed previous treatment paradigm of advanced urothelial carcinoma (UC). The ARON-2 study (NCT05290038) aimed to assess the real-world effectiveness of pembrolizumab in patients recurred or progressed after platinum-based chemotherapy. PATIENTS AND METHODS: Medical records of patients with documented metastatic UC treated by pembrolizumab as second-line therapy were retrospectively collected from 88 institutions in 23 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS) and overall response rate (ORR). Cox proportional hazards models were adopted to explore the presence of prognostic factors. RESULTS: In total, 836 patients were included: 544 patients (65%) received pembrolizumab after progression to first-line platinum-based chemotherapy in the metastatic setting (cohort A) and 292 (35%) after recurring within < 12 months since the completion of adjuvant or neoadjuvant chemotherapy (cohort B). The median follow-up time was 15.3 months. The median OS and the ORR were 10.5 months and 31% in the overall study population, 9.1 months and 29% in cohort A and 14.6 months and 37% in cohort B. At multivariate analysis, ECOG-PS ≥ 2, bone metastases, liver metastases and pembrolizumab setting (cohort A vs B) proved to be significantly associated with worst OS and PFS. Stratified by the presence of 0, 1-2 or 3-4 prognostic factors, the median OS was 29.4, 12.5 and 4.1 months (p < 0.001), while the median PFS was 12.2, 6.4 and 2.8 months, respectively (p < 0.001). CONCLUSIONS: Our study confirms that pembrolizumab is effective in the advanced UC real-world context, showing outcome differences between patients recurred or progressed after platinum-based chemotherapy.
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