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Title: Validation of the International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) prognostic model for first-line pazopanib in metastatic renal carcinoma: the Spanish Oncologic Genitourinary Group (SOGUG) SPAZO study.
Authors: Pérez-Valderrama, B
Arranz Arija, J A
Rodríguez Sánchez, A
Pinto Marín, A
Borrega García, P
Castellano Gaunas, D E
Rubio Romero, G
Maximiano Alonso, C
Villa Guzmán, J C
Puertas Álvarez, J L
Chirivella González, I
Méndez Vidal, M J
Juan Fita, M J
León-Mateos, L
Lázaro Quintela, M
García Domínguez, R
Jurado García, J M
Vélez de Mendizábal, E
Lambea Sorrosal, J J
García Carbonero, I
González del Alba, A
Suárez Rodríguez, C
Jiménez Gallego, P
Meana García, J A
García Marrero, R D
Gajate Borau, P
Santander Lobera, C
Molins Palau, C
López Brea, M
Fernández Parra, E M
Reig Torras, O
Basterretxea Badiola, L
Vázquez Estévez, S
González Larriba, J L
Keywords: metastatic renal cell cancer;pazopanib;prognostic classification;tyrosine kinase inhibitors
metadata.dc.subject.mesh: Adult
Carcinoma, Renal Cell
Databases, Factual
Disease-Free Survival
Kaplan-Meier Estimate
Middle Aged
Molecular Targeted Therapy
Retrospective Studies
Risk Factors
Issue Date: 9-Dec-2015
Abstract: Patients 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.
metadata.dc.identifier.doi: 10.1093/annonc/mdv601
Appears in Collections:Producción 2020

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