RT Journal Article T1 Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies. A1 Castellano, Daniel A1 Maroto, José Pablo A1 Espinosa, Enrique A1 Grande, Enrique A1 Bolós, M Victoria A1 Llinares, Julia A1 Esteban, Emilio A1 González Del Alba, Aranzazu A1 Climent, Miguel Angel A1 Arranz, Jose Angel A1 Méndez, Mª José A1 Fernández Parra, Eva A1 Antón-Aparicio, Luis A1 Bayona, Cristina A1 Gallegos, Isabel A1 Gallardo, Enrique A1 Samaniego, Luz A1 García Donas, Jesús K1 Effectiveness K1 routine clinical practice K1 safety K1 sunitinib AB A 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  YR 2017 FD 2017-08-28 LK http://hdl.handle.net/10668/11225 UL http://hdl.handle.net/10668/11225 LA en DS RISalud RD Apr 10, 2025