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Global real-world experiences with pembrolizumab in advanced urothelial carcinoma after platinum-based chemotherapy: the ARON-2 study.
Massari, Francesco; Santoni, Matteo; Takeshita, Hideki; Okada, Yohei; Tapia, Jose Carlos; Basso, Umberto; Maruzzo, Marco; Scagliarini, Sarah; Büttner, Thomas; Fornarini, Giuseppe; Myint, Zin W; Galli, Luca; Souza, Vinicius Carrera; Pichler, Renate; De Giorgi, Ugo; Gandur, Nathalia; Lam, Elaine T; Gilbert, Danielle; Popovic, Lazar; Grande, Enrique; Mammone, Giulia; Berardi, Rossana; Crabb, Simon J; Kemp, Robert; Molina-Cerrillo, Javier; Freitas, Marcelo; Luz, Murilo; Iacovelli, Roberto; Calabrò, Fabio; Tural, Deniz; Atzori, Francesco; Küronya, Zsófia; Chiari, Rita; Campos, Saul; Caffo, Orazio; Fay, André P; Kucharz, Jakub; Zucali, Paolo Andrea; Rinck, José Augusto; Zeppellini, Annalisa; Bastos, Diogo Assed; Aurilio, Gaetano; Mota, Augusto; Trindade, Karine; Ortega, Cinzia; Sade, Juan Pablo; Rizzo, Mimma; Fiala, Ondrej; Vau, Nuno; Giannatempo, Patrizia.
Afiliación
  • Massari F; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. francesco.massari@aosp.bo.it.
  • Santoni M; Oncology Unit, Macerata Hospital, via Santa Lucia 2, 62100, Macerata, Italy.
  • 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.
  • Tapia JC; Department of Medical Oncology, Institut d'Investigació Biomèdica Sant Pau, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  • Basso U; Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, 35128, Padova, Italy.
  • Maruzzo M; Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, 35128, Padova, Italy.
  • Scagliarini S; UOC di Oncologia, Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli, Naples, Italy.
  • Büttner T; Department of Urology, University Hospital Bonn (UKB), 53127, Bonn, Germany.
  • Fornarini G; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Myint ZW; Markey Cancer Center, University of Kentucky, Lexington, KY, 40536-0293, USA.
  • Galli L; Oncology Unit 2, University Hospital of Pisa, 56126, Pisa, Italy.
  • Souza VC; Hospital São Rafael Oncologia D'Or, Salvador, BA, Brazil.
  • Pichler R; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • De Giorgi U; Department of Urology, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.
  • Gandur N; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
  • Lam ET; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • Gilbert D; Hospital Angel Roffo, Buenos Aires, CABA, Argentina.
  • Popovic L; University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
  • Grande E; University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
  • Mammone G; Oncology Institute of Vojvodina, Faculty of Medicine, University Novi Sad, Novi Sad, Serbia.
  • Berardi R; Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.
  • Crabb SJ; Department of Radiological, Oncological and Anatomo-Pathological Science, "Sapienza" University of Rome, Viale Regina Elena 324, 00185, Rome, Italy.
  • Kemp R; Department of Medical Oncology, Università Politecnica Delle Marche, AOU Ospedali Riuniti Delle Marche, Ancona, Italy.
  • Molina-Cerrillo J; Southampton Experimental Cancer Medicine Centre, University of Southampton, Southampton, UK.
  • Freitas M; Southampton Experimental Cancer Medicine Centre, University of Southampton, Southampton, UK.
  • Luz M; Department of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain.
  • Iacovelli R; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • Calabrò F; Centro de Pesquisas Oncológicas - CEPON, Florianópolis, SC, Brazil.
  • Tural D; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • Atzori F; Hospital Erasto Gaertner, Curitiba, PR, Brazil.
  • Küronya Z; Oncologia Medica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
  • Chiari R; Department of Oncology, San Camillo Forlanini Hospital, Rome, Italy.
  • Campos S; Department of Medical Oncology, Bakirköy Dr. SadiKonuk Training and Research Hospital, Tevfik Saglam St. No: 11, Zuhuratbaba District, Bakirkoy, Istanbul, Turkey.
  • Caffo O; Unità di Oncologia Medica, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy.
  • Fay AP; Department of Genitourinary Medical Oncology and Clinical Pharmacology, National Institute of Oncology, Budapest, Hungary.
  • Kucharz J; UOC Oncologia, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Fano, Italy.
  • Zucali PA; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • Rinck JA; Centro Oncologico Estatal "Dr José Luis Barrera Franco" del ISSEMYM, Toluca de Lerdo, Mexico.
  • Zeppellini A; Medical Oncology Unit, Santa Chiara Hospital, Trento, Italy.
  • Bastos DA; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • Aurilio G; Pontificia Universidade Católica do Rio Grande do Sul - PUCRS, Porto Alegre, RS, Brazil.
  • Mota A; Department of Uro-Oncology, Maria Sklodowska-Curie National Research Institute of Oncology Warsaw, Warsaw, Poland.
  • Trindade K; Department of Oncology, IRCCS Humanitas Research Hospital, Rozzano - Milan, Italy.
  • Ortega C; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
  • Sade JP; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • Rizzo M; Hospital AC Camargo, São Paulo, SP, Brazil.
  • Fiala O; Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Vau N; Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
  • Giannatempo P; Department of Oncology, Hospital Sírio-Libanês, São Paulo, SP, Brazil.
Cancer Immunol Immunother ; 73(6): 106, 2024 Apr 18.
Article en En | MEDLINE | ID: mdl-38634928
ABSTRACT

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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Vejiga Urinaria / Carcinoma de Células Transicionales / Anticuerpos Monoclonales Humanizados Límite: Humans Idioma: En Revista: Cancer Immunol Immunother Asunto de la revista: ALERGIA E IMUNOLOGIA / NEOPLASIAS / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Alemania
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Vejiga Urinaria / Carcinoma de Células Transicionales / Anticuerpos Monoclonales Humanizados Límite: Humans Idioma: En Revista: Cancer Immunol Immunother Asunto de la revista: ALERGIA E IMUNOLOGIA / NEOPLASIAS / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Alemania