Avelumab maintenance in advanced urothelial carcinoma: real-world data from Northern Spain (AVEBLADDER study)

• Marta Sotelo ^[1] ; Mireia Pelaez ^[2] ; Laura Basterretxea ^[3] ; Estrella Varga ^[4] ; Ricardo Sánchez-Escribano ^[5] ; Eduardo Pujol Obis ^[6] ; Carmen Santander ^[7] ; Mireia Martínez Kareaga ^[14] ; Mikel Arruti Ibarbia ^[15] ; Inmaculada Rodríguez Ledesma ^[8] ; Carlos Álvarez Fernández ^[9] ; Pablo Piedra ^[4] ; Verónica Calderero Aragón ^[10] ; Nuria Lainez ^[4] ; Juan Antonio Verdún Aguilar ^[11] ; Irene Gil Arnáiz ^[12] ; Ricardo Fernández ^[13] ; Cristina Mazas ^[2] ; Ignacio Durán ^[1]
  1. [1] Hospital Universitario Marqués de Valdecilla

     Hospital Universitario Marqués de Valdecilla

     Santander, España

     
  2. [2] Universidad Europea del Atlántico

     Universidad Europea del Atlántico

     Santander, España

     
  3. [3] Hospital Universitario de Donostia

     Hospital Universitario de Donostia

     San Sebastián, España

     
  4. [4] Hospital Universitario de Navarra

     Hospital Universitario de Navarra

     Pamplona, España

     
  5. [5] Hospital Universitario de Valladolid

     Hospital Universitario de Valladolid

     Valladolid, España

     
  6. [6] Hospital Clínico Universitario Lozano Blesa

     Hospital Clínico Universitario Lozano Blesa

     Zaragoza, España

     
  7. [7] Hospital Miguel Servet

     Hospital Miguel Servet

     Zaragoza, España

     
  8. [8] Complejo Asistencial Universitario de Burgos

     Complejo Asistencial Universitario de Burgos

     Burgos, España

     
  9. [9] Hospital Universitario Central de Asturias

     Hospital Universitario Central de Asturias

     Oviedo, España

     
  10. [10] Hospital Universitario San Jorge de Pereira

      Hospital Universitario San Jorge de Pereira

      Colombia

      
  11. [11] Hospital Comarcal de Alcañiz

      Hospital Comarcal de Alcañiz

      Alcañiz, España

      
  12. [12] Hospital Reina Sofía

      Hospital Reina Sofía

      Tudela, España

      
  13. [13] Hospital Universitario de Cruces

      Hospital Universitario de Cruces

      Barakaldo, España

      
  14. [14] Hospital Universitario de Araba-Txagorritxu, Araba, Spain
  15. [15] Hospital Galdakao-Usansolo, Bizkaia, Spain

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 27, Nº. 12, 2025, págs. 4481-4492
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Background Before the incorporation of enfortumab vedotin with pembrolizumab, the standard of care for patients with locally advanced or metastatic urothelial carcinoma who do not progress after platinum-based chemotherapy was avelumab maintenance therapy, as demonstrated by the JAVELIN 100 trial. However, real-world European data remain scarce.

    Patients and Methods AVEBLADDER is a retrospective study conducted at 14 hospitals in Northern Spain, including patients with locally advanced or metastatic urothelial carcinoma diagnosed between January 2021 and June 2023. Outcomes of overall survival (OS) and progression-free survival (PFS) were analyzed for patients treated with platinum-based chemotherapy, with and without subsequent avelumab maintenance therapy. non-avelumab patients. Median PFS was 11.33 months (95% CI: 10–13.6) with avelumab and 6.43 months (95% CI: 6–7.6) without. One-year OS probabilities were 81.6% vs. 45.6% (p<0.001) in the avelumab and non-avelumab groups, respectively. No unexpected toxicities were reported.

    Conclusions Despite proven survival benefits, avelumab uptake in real-world practice is limited by barriers like access, reimbursement, and awareness. These findings align with JAVELIN 100 and underscore the need for further real-world studies to address treatment disparities.