Castellano, DanielMaroto, José PabloEspinosa, EnriqueGrande, EnriqueBolós, M VictoriaLlinares, JuliaEsteban, EmilioGonzález Del Alba, AranzazuCliment, Miguel AngelArranz, Jose AngelMéndez, Mª JoséFernández Parra, EvaAntón-Aparicio, LuisBayona, CristinaGallegos, IsabelGallardo, EnriqueSamaniego, LuzGarcía Donas, Jesús2023-01-252023-01-252017-08-28http://hdl.handle.net/10668/11225A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon-α in metastatic renal cell carcinoma (mRCC) patients. To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice. Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals. Tumor response, Progression-free survival (PFS) and overall survival (OS), and main sunitinib-related toxicities were registered. 224 patients were analyzed. Median PFS 10.6 months (95% CI: 9.02-12.25), median OS 21.9 months (95% CI: 17.2-26.6). Objective response rate (ORR) 43.8% (95% CI: 36.8-50.7). Median time to PR was 3.8 months (95% CI: 3.86-5.99) and to CR 8.2 months (95% CI: 4.75-9.77). The most common ≥ grade-3 AEs were asthenia/fatigue (18.7%), hand-foot syndrome (6.2%), hypertension (5.8%) and neutropenia (4.8%). Hand-foot syndrome, diarrhea and mucositis were confirmed as independent predictors for PFS and/or OS in a multivariate analysis (p enEffectivenessroutine clinical practicesafetysunitinibAngiogenesis InhibitorsAntineoplastic AgentsCarcinoma, Renal CellDisease-Free SurvivalHumansIndolesKidney NeoplasmsNeoplasm MetastasisPyrrolesRandomized Controlled Trials as TopicSpainSunitinibSurvival RateTreatment Outcomeresearch article28535693open access10.1080/14740338.2017.13304101744-764Xhttps://ruc.udc.es/dspace/bitstream/2183/28112/2/Castellano_Experience_Sunitib.pdf