Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience
Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu časopisecké články, pozorovací studie
PubMed
39980145
PubMed Central
PMC11842279
DOI
10.1002/cam4.70479
Knihovny.cz E-zdroje
- Klíčová slova
- ARON‐2 study, NCT05290038, chemotherapy, enfortumab vedotin, pembrolizumab, real‐world data, sequencing, urothelial carcinoma,
- MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- humanizované monoklonální protilátky terapeutické užití aplikace a dávkování MeSH
- imunokonjugáty * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- karcinom z přechodných buněk * farmakoterapie mortalita patologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- monoklonální protilátky * terapeutické užití aplikace a dávkování MeSH
- nádory močového měchýře * farmakoterapie mortalita patologie MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- urologické nádory * farmakoterapie mortalita patologie MeSH
- výsledek terapie 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
- pozorovací studie MeSH
- Názvy látek
- enfortumab vedotin MeSH Prohlížeč
- humanizované monoklonální protilátky MeSH
- imunokonjugáty * MeSH
- monoklonální protilátky * MeSH
- pembrolizumab MeSH Prohlížeč
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 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 Urology Saitama Medical Center Saitama Medical University Saitama Japan
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
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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ClinicalTrials.gov
NCT05290038