Pérez-Valderrama, BArranz Arija, J ARodríguez Sánchez, APinto Marín, ABorrega García, PCastellano Gaunas, D ERubio Romero, GMaximiano Alonso, CVilla Guzmán, J CPuertas Álvarez, J LChirivella González, IMéndez Vidal, M JJuan Fita, M JLeón-Mateos, LLázaro Quintela, MGarcía Domínguez, RJurado García, J MVélez de Mendizábal, ELambea Sorrosal, J JGarcía Carbonero, IGonzález del Alba, ASuárez Rodríguez, CJiménez Gallego, PMeana García, J AGarcía Marrero, R DGajate Borau, PSantander Lobera, CMolins Palau, CLópez Brea, MFernández Parra, E MReig Torras, OBasterretxea Badiola, LVázquez Estévez, SGonzález Larriba, J L2023-01-252023-01-252015-12-09http://hdl.handle.net/10668/9662Patients with metastatic renal carcinoma (mRCC) treated with first-line pazopanib were not included in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic model. SPAZO (NCT02282579) was a nation-wide retrospective observational study designed to assess the effectiveness and validate the IMDC prognostic model in patients treated with first-line pazopanib in clinical practice. Data of 278 patients, treated with first-line pazopanib for mRCC in 34 centres in Spain, were locally recorded and externally validated. Mean age was 66 years, there were 68.3% male, 93.5% clear-cell type, 74.8% nephrectomized, and 81.3% had ECOG 0-1. Metastatic sites were: lung 70.9%, lymph node 43.9%, bone 26.3%, soft tissue/skin 20.1%, liver 15.1%, CNS 7.2%, adrenal gland 6.5%, pleura/peritoneum 5.8%, pancreas 5%, and kidney 2.2%. After median follow-up of 23 months, 76.4% had discontinued pazopanib (57.2% due to progression), 47.9% had received second-line targeted therapy, and 48.9% had died. According to IMDC prognostic model, 19.4% had favourable risk (FR), 57.2% intermediate risk (IR), and 23.4% poor risk (PR). No unexpected toxicities were recorded. Response rate was 30.3% (FR: 44%, IR: 30% PR: 17.3%). Median progression-free survival (whole population) was 11 months (32 in FR, 11 in IR, 4 in PR). Median and 2-year overall survival (whole population) were 22 months and 48.1%, respectively (FR: not reached and 81.6%, IR: 22 and 48.7%, PR: 7 and 18.8%). These estimations and their 95% confidence intervals are fully consistent with the outcomes predicted by the IMDC prognostic model. Our results validate the IMDC model for first-line pazopanib in mRCC and confirm the effectiveness and safety of this treatment.enmetastatic renal cell cancerpazopanibprognostic classificationtyrosine kinase inhibitorsAdultAgedCarcinoma, Renal CellDatabases, FactualDisease-Free SurvivalFemaleHumansIndazolesKaplan-Meier EstimateMaleMiddle AgedMolecular Targeted TherapyPrognosisPyrimidinesRetrospective StudiesRisk FactorsSpainSulfonamidesresearch article26658889open access10.1093/annonc/mdv6011569-8041https://doi.org/10.1093/annonc/mdv601