The SPRWEC study investigated cabozantinib effectiveness and safety in patients with advanced renal cell carcinoma (RCC) in real-world Spanish and Portuguese settings.
Observational, ambispective, multicenter study including adult patients with advanced RCC receiving cabozantinib between October 2016 and May 2020 as second or subsequent treatment line. Primary endpoint was progression-free survival (PFS).
About 258 patients (mean [SD] age 62.5 [11.0] years, 75.6% male) were included, 55.8% with prior immunotherapy. Median follow-up was 34.3 months. Median PFS was 7.63 months (95% CI, 6.64-8.72). Median overall survival (OS) was 15.36 months (95% CI, 11.58-19.11); objective response rate (ORR), 29.5% (95% CI, 24.0-35.4); median time to first response, 3.27 months (95% CI, 3.03-3.68); median duration of response, 9.77 months (95% CI, 7.24-12.63); median time to discontinuation, 6.97 months (95% CI, 5.79-8.42). Prior immunotherapy increased ORR (OR 2.132) and decreased OS (HR 1.529). ECOG 0-1 and dose reductions were associated with increased PFS (HR 0.470 and 0.558); poor and intermediate MSKCC (HR 3.861 and 1.681) and IMDC risks (HR 2.558 and 1.537) with decreased PFS. Most common AEs were diarrhea (41.9%), asthenia (34.9%), and anorexia (18.2%).
Cabozantinib's effectiveness and safety as second or subsequent treatment line for advanced RCC in real-world settings are similar to those observed in clinical trials. This treatment after prior immunotherapy, the front-line standard of care, resulted in increased ORR and decreased OS, without changes in PFS.
Clinical genitourinary cancer. 2025 Jul 23 [Epub ahead of print]
Cristina Suárez, Òscar Reig Torras, Rafael Morales Barrera, Ángel Rodríguez Sánchez, Georgia Anguera Palacios, André Miguel Branco Manshino, Natalia Fernández Núñez, María José Méndez Vidal, Icíar García Carbonero, Ovidio Fernández Calvo, Regina Gironés Sarrió, Guillermo Crespo Herrero, Javier Afonso Afonso, María José Juan Fita, Josep Gumà Padró, Martín Lázaro Quintela, Alejo Rodriguez-Vida, Carolina Hernández Pérez, Ana Medina Colmenero, Ricardo Collado Martín, Carmen Garcías de España, Carmen Molins Palau, Esther Martínez Ortega, Enrique Gallardo, SPRWEC Study investigators
Medical Oncology, Vall d´Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d´Hebron, Barcelona, Spain. Electronic address: ., Medical Oncology Department, Hospital Clínic de Barcelona, Translational Genomics and Targeted Therapies in Solid Tumors, Barcelona, Spain., Medical Oncology, Vall d´Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d´Hebron, Barcelona, Spain., Hospital Universitario de León, León, Spain., Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, Lisboa, Portugal., Hospital Universitario Lucus Augusti, Lugo, Spain., Hospital Universitario Reina Sofía, Córdoba, Spain., Hospital Virgen de la Salud, Toledo, Spain., Complejo Hospitalario Universitario de Ourense, Ourense, Spain., Medical Oncology Service. Hospital Universitari i Politècnic La Fe and Conselleria de Sanitat de la Comunitat Valenciana, Valencia, Spain., Hospital Universitario de Burgos, Burgos, Spain., Complejo Hospitalario Universitario de Ferrol. Ferrol, A Coruña, Spain., Fundación Instituto Valenciano de Oncología, Profesor Beltrán Baguena, Valencia, Spain., Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain., Hospital Álvaro Cunqueiro, Vigo, Spain., Hospital del Mar, Barcelona, Spain., Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Tenerife, Spain., Fundación Centro Oncológico de Galicia, A Coruña, Spain., Hospital San Pedro de Alcántara, Cáceres, Spain., Hospital Universitari Son Espases, Palma de Mallorca, Balearic Islands, Spain., Hospital Universitario Dr. Peset, Valencia, Spain., Complejo Hospitalario de Jaén, Jaén, Spain., Department of Oncology, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.