Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience

. 2025 Feb ; 14 (4) : e70479.

Jazyk angličtina Země Spojené státy americké Médium print

Typ dokumentu časopisecké články, pozorovací studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid39980145

BACKGROUND: Recently, a plethora of novel systemic agents have been incorporated into the therapeutic armamentarium of advanced urothelial carcinoma (aUC). The antibody-drug conjugate (ADC), enfortumab vedotin (EV), has demonstrated relevant clinical benefit in patients with aUC refractory to platinum and immune-checkpoint inhibitor (ICI) therapy. Our study provides a retrospective, international, real-world analysis comparing the effectiveness of EV to chemotherapy in this setting. METHODS: The data were extracted from the medical records of patients treated with EV or chemotherapy following pembrolizumab for recurrent or progressive aUC after platinum-based chemotherapy. Patients were assessed for overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR). RESULTS: Our analysis included 247 patients treated with EV (88, 36%) or chemotherapy (159, 64%). Median OS was 9.1 months (95%CI 7.2-10.7) in the overall study population, 13.6 months (95%CI 10.0-31.0) in patients receiving EV and 6.8 months (95%CI 6.0-8.9) in patients receiving chemotherapy (p < 0.001). The OS benefit of EV was not affected by primary tumour site and histology, metastatic sites, type of first platinum-based chemotherapy or response to pembrolizumab. In the EV cohort, the median PFS was significantly longer (8.8 months [95%CI 6.5-17.0] vs. 3.0 months [95%CI 2.6-3.7]) and the ORR was significantly higher (56% vs. 23%) than in the chemotherapy cohort. CONCLUSIONS: The results of our international analysis of real-world data confirm the effectiveness of EV in the sequential strategy of aUC patients who have received prior platinum-based chemotherapy and anti-PD-1 pembrolizumab, regardless of commonly considered prognostic factors. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05290038.

Chair of Oncology Interdisciplinary Department of Medicine University of Bari Aldo Moro Bari Italy

Department of Adult Medical Oncology King Fahad Specialist Hospital Dammam Dammam Saudi Arabia

Department of Comprehensive Cancer Care Masaryk Memorial Cancer Institute Brno Czech Republic

Department of Health Sciences Section of Clinical Pharmacology and Oncology University of Florence Florence Italy

Department of Hemato Oncology Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Universidad Panamericana Mexico City Mexico

Department of Medical and Surgical Sciences University of Bologna Bologna Italy

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 Medicine and Surgery University of Parma Parma Italy

Department of Precision Medicine in Medical Surgical and Critical Care Section of Medical Oncology University of Palermo Palermo Italy

Department of Urology Saitama Medical Center Saitama Medical University Saitama Japan

Division of Medical Oncology Department of Internal Medicine Markey Cancer Center University of Kentucky Lexington Kentucky USA

Faculty of Medicine Masaryk University Brno Czech Republic

Faculty of Medicine Oncology Institute of Vojvodina University of Novi Sad Novi Sad Serbia

Hospital Israelita Albert Einstein São Paulo Brazil

Hospital Sírio Libanês Brasília Brazil

Klinik für Urologie Universitätsklinikum Schleswig Holstein Campus Lübeck Lübeck Germany

Latin American Cooperative Oncology Group LACOG Porto Alegre Brazil

Medical Oncology Department Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy

Medical Oncology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy

Medical Oncology Unit Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Bari Italy

Medical Oncology Unit IRCCS Casa Sollievo della Sofferenza Foggia Italy

Medical Oncology Unit Macerata Hospital Macerata Italy

Medical Oncology Unit University Hospital of Parma Parma Italy

Medicine and Pharmacy Faculty National Institute of Oncology Medical Oncology Unit Mohamed 5 University Rabat Morocco

Niguarda Cancer Center Grande Ospedale Metropolitano Niguarda Milan Italy

Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea

Taussig Cancer Institute Cleveland Clinic Cleveland Ohio USA

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