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Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2EV Study
O. Fiala, F. Massari, U. Basso, P. Giannatempo, E. Grande, S. Buti, ZW. Myint, U. De Giorgi, R. Pichler, F. Grillone, Y. Ürün, F. Calabrò, MT. Bourlon, L. Galli, R. Kanesvaran, G. Roviello, J. Kucharz, M. Rizzo, SH. Park, L. Cerbone, E. Seront,...
Jazyk angličtina Země Francie
Typ dokumentu časopisecké články
NLK
ProQuest Central
od 2006-01-01 do Před 1 rokem
Medline Complete (EBSCOhost)
od 2006-01-01 do Před 1 rokem
Nursing & Allied Health Database (ProQuest)
od 2006-01-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 2006-01-01 do Před 1 rokem
Family Health Database (ProQuest)
od 2006-01-01 do Před 1 rokem
- MeSH
- dospělí MeSH
- humanizované monoklonální protilátky * terapeutické užití farmakologie MeSH
- karcinom z přechodných buněk farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- monoklonální protilátky * terapeutické užití farmakologie MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití farmakologie MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- urologické nádory farmakoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Enfortumab vedotin (EV) has been approved for the treatment of patients with locally advanced/metastatic urothelial carcinoma (la/mUC) who previously received platinum-based chemotherapy followed by immune checkpoint inhibitors. However, the pivotal clinical trials did not include patients previously treated with avelumab maintenance therapy. OBJECTIVE: The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2EV study. PATIENTS AND METHODS: The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. RESULTS: Median OS and PFS were 12.7 (95% CI 10.2-14.1) and 7.9 (95% CI 6.4-9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1-11.4). The incidence of grade ≥ 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade ≥ 3 diarrhea and 4% of grade ≥ 3 hyperglycemia. CONCLUSIONS: The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab.
Biomedical Center Faculty of Medicine in Pilsen Charles University Pilsen Czech Republic
Centro Paulista de Oncologia Oncoclínicas São Paulo SP Brazil
Clinical Oncology Genitourinary Oncology Unit Alexander Fleming Institute Buenos Aires Argentina
Department of Internal Medicine and Medical Specialties University of Genoa Genoa Italy
Department of Medical and Surgical Sciences University of Bologna Bologna Italy
Department of Medical Oncology Cliniques Universitaires Saint Luc Brussels Belgium
Department of Medical Oncology Faculty of Medicine Ankara University Ankara Turkey
Department of Medical Oncology Hospital Ramón y Cajal Madrid Spain
Department of Medical Oncology MD Anderson Cancer Center Madrid Madrid Spain
Department of Medical Oncology San Camillo Forlanini Hospital Rome Italy
Department of Medicine and Surgery Federico 2 University Naples Italy
Department of Medicine and Surgery University of Parma Parma Italy
Department of Urology Medical University of Innsbruck Innsbruck Austria
Department of Urology Saitama Medical Center Saitama Medical University Saitama Japan
Dipartimento di Oncologia Ospedale San Lazzaro Azienda sanitaria locale CN2 Alba Cuneo Italy
Division of Cancer Prevention and Genetics IEO European Institute of Oncology IRCCS Milan Italy
Division of Medical Oncology National Cancer Centre Singapore Singapore Singapore
Escuela de Medicina Universidad Panamericana Mexico City Mexico
Faculty of Medicine Masaryk University Brno Czech Republic
Harvard Medical School Boston MA USA
Hospital Israelita Albert Einstein São Paulo SP Brazil
Hospital Sírio Libanês Brasília DF Brazil
IRCCS Ospedale Policlinico San Martino Genoa Italy
Lank Center for Genitourinary Oncology Dana Farber Cancer Institute Boston MA USA
Latin American Cooperative Oncology Group LACOG Porto Alegre Brazil
Masaryk Memorial Cancer Institute Brno Czech Republic
Medical Oncology 1 IRCCS Regina Elena National Cancer Institute Rome Italy
Medical Oncology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy
Medical Oncology Ospedale Santa Corona Pietra Ligure Italy
Medical Oncology Unit 2 Azienda Ospedaliera Universitaria Pisana Pisa Italy
Medical Oncology Unit Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Bari Italy
Medical Oncology Unit Macerata Hospital Macerata Italy
Medical Oncology Unit Ospedale San Paolo Savona Italy
Medical Oncology Unit University Hospital of Parma Parma Italy
Oncologia Dip Scienze e Biotecnologie Medico chirurgiche Policlinico Umberto 1 Rome Italy
Oncology Unit A R N A S Civico Palermo Italy
Oncology Unit S Maria Delle Grazie Hospital ASL NA2 NORD Pozzuoli Naples Italy
Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
Servicio de Oncología Hospital Universitario La Paz Madrid Spain
Taussig Cancer Institute Cleveland Clinic Cleveland OH USA
U O Oncologia Ospedale di Civitanova Marche Civitanova Marche Italy
Citace poskytuje Crossref.org
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- $a Fiala, Ondřej $u Department of Oncology and Radiotherapeutics, Faculty of Medicine, University Hospital in Pilsen, Charles University, alej Svobody 80, 30460, Pilsen, Czech Republic. fialao@fnplzen.cz $u Biomedical Center, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czech Republic. fialao@fnplzen.cz $1 https://orcid.org/0000000240967385
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- $a BACKGROUND: Enfortumab vedotin (EV) has been approved for the treatment of patients with locally advanced/metastatic urothelial carcinoma (la/mUC) who previously received platinum-based chemotherapy followed by immune checkpoint inhibitors. However, the pivotal clinical trials did not include patients previously treated with avelumab maintenance therapy. OBJECTIVE: The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2EV study. PATIENTS AND METHODS: The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. RESULTS: Median OS and PFS were 12.7 (95% CI 10.2-14.1) and 7.9 (95% CI 6.4-9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1-11.4). The incidence of grade ≥ 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade ≥ 3 diarrhea and 4% of grade ≥ 3 hyperglycemia. CONCLUSIONS: The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab.
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