Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study.

Autor: Santoni M; Oncology Unit, Macerata Hospital, Via Santa Lucia 2, 62100, Macerata, Italy. mattymo@alice.it., Myint ZW; Markey Cancer Center, University of Kentucky, Lexington, KY, 40536-0293, USA., Büttner T; Department of Urology, University Hospital Bonn (UKB), 53127, Bonn, Germany., Takeshita H; Department of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan., Okada Y; Department of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan., Lam ET; University of Colorado Cancer Center, Anschutz Medical Campus, Aurora, CO, USA., Gilbert D; University of Colorado Cancer Center, Anschutz Medical Campus, Aurora, CO, USA., Küronya Z; Department of Genitourinary Medical Oncology and Clinical Pharmacology, National Institute of Oncology, Budapest, Hungary., Tural D; Department of Medical Oncology, Bakirköy Dr. Sadi Konuk Training and Research Hospital, Zuhuratbaba District, Tevfik Saglam St. No: 11, Bakirkoy, Istanbul, Turkey., Pichler R; Department of Urology, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria., Grande E; Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain., Crabb SJ; Southampton Experimental Cancer Medicine Centre, University of Southampton, Southampton, UK., Kemp R; Southampton Experimental Cancer Medicine Centre, University of Southampton, Southampton, UK., Massari F; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Via Albertoni - 15, Bologna, Italy., Scagliarini S; UOC di Oncologia, Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli, Naples, Italy., Iacovelli R; Oncologia Medica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy., Vau N; Urologic Oncology, Champalimaud Clinical Center, 1400-038, Lisbon, Portugal., Basso U; Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, 35128, Padua, Italy., Maruzzo M; Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, 35128, Padua, Italy., Molina-Cerrillo J; Department of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain., Galli L; Oncology Unit 2, University Hospital of Pisa, 56126, Pisa, Italy., Bamias A; 2nd Propaedeutic Department of Internal Medicine, School of Medicine, ATTIKON University Hospital, National and Kapodistrian University of Athens, Athens, Greece., De Giorgi U; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy., Zucali PA; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.; Department of Oncology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy., Rizzo M; Division of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Piazza G. Cesare 11, 70124, Bari, Italy., Seront E; Department of Medical Oncology, Centre Hospitalier de Jolimont, Haine Saint Paul, Belgium., Popovic L; Oncology Institute of Vojvodina, Faculty of Medicine, University Novi Sad, Novi Sad, Serbia., Caffo O; Medical Oncology Unit, Santa Chiara Hospital, Trento, Italy., Buti S; Medical Oncology Unit, Department of Medicine and Surgery, University Hospital of Parma, University of Parma, Parma, Italy., Kanesvaran R; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Kopecky J; Department of Clinical Oncology and Radiotherapy, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic., Kucharz J; Department of Uro-Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland., Zeppellini A; Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy., Fiala O; Department of Oncology and Radiotherapeutics, Faculty of Medicine and University Hospital in Pilsen, Charles University, Pilsen, Czech Republic., Landmesser J; Klinik für Urologie, Ratzeburger Allee 160, 23538, Lübeck, Germany., Ansari J; Medical Oncology, Tawam Hospital, Al Ain, United Arab Emirates., Giannatempo P; Dipartimento di Oncologia Medica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Rizzo A; Struttura Semplice Dipartimentale di Oncologia Medica per la Presa in Carico Globale del Paziente Oncologico 'Don Tonino Bello', I.R.C.C.S. Istituto Tumori 'Giovanni Paolo II', Bari, Italy., Zabalza IO; Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain., Monteiro FSM; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.; Oncology and Hematology Department, Hospital Santa Lucia, SHLS 716 Cj. C, Brasília, DF, 70390-700, Brazil., Battelli N; Oncology Unit, Macerata Hospital, Via Santa Lucia 2, 62100, Macerata, Italy., Calabrò F; Department of Oncology, San Camillo Forlanini Hospital, Rome, Italy., Porta C; Division of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Piazza G. Cesare 11, 70124, Bari, Italy.; Interdisciplinary Department of Medicine, University of Bari 'Aldo Moro', Bari, Italy.
Jazyk: angličtina
Zdroj: Cancer immunology, immunotherapy : CII [Cancer Immunol Immunother] 2023 Sep; Vol. 72 (9), pp. 2961-2970. Date of Electronic Publication: 2023 May 29.
DOI: 10.1007/s00262-023-03469-5
Abstrakt: Background: The advent of immune-checkpoint inhibitors has challenged previous treatment paradigms for advanced urothelial carcinoma (UC) in the post-platinum setting as well as in the first-line setting for cisplatin-ineligible patients. In this study, we investigated the effectiveness of pembrolizumab as first-line treatment for cisplatin-ineligible UC.
Methods: Data from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study.
Results: Our analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD.
Conclusions: Our data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.
(© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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