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.

Autor:	Pérez-Valderrama B; Department of Medical Oncology, Virgen del Rocío University Hospitals, Sevilla bperezv@gmail.com., Arranz Arija JA; Department of Medical Oncology, Gregorio Marañón General University Hospital, Madrid., Rodríguez Sánchez A; Department of Medical Oncology, University Hospital of León, Leon., Pinto Marín A; Department of Medical Oncology, La Paz University Hospital, Madrid., Borrega García P; Department of Medical Oncology, San Pedro de Alcántara Hospital, Cáceres., Castellano Gaunas DE; Department of Medical Oncology, 12 de Octubre University Hospital, Madrid., Rubio Romero G; Department of Medical Oncology, Fundación Jiménez Díaz University Hospital, Madrid., Maximiano Alonso C; Department of Medical Oncology, Puerta de Hierro University Hospital, Majadahonda (Madrid)., Villa Guzmán JC; Department of Medical Oncology, General University Hospital of Ciudad Real, Ciudad Real., Puertas Álvarez JL; Department of Medical Oncology, Rio Hortega University Hospital, Valladolid., Chirivella González I; Department of Medical Oncology, University Hospital of Valencia, Valencia., Méndez Vidal MJ; Department of Medical Oncology, Reina Sofía University Hospital, Córdoba., Juan Fita MJ; Department of Medical Oncology, Valencian Institute of Oncology, Valencia., León-Mateos L; Department of Medical Oncology, Santiago University Hospital Complex, Santiago de Compostela., Lázaro Quintela M; Department of Medical Oncology, University Hospital Complex of Vigo, Vigo., García Domínguez R; Department of Medical Oncology, Clinic University Hospital of Salamanca, Salamanca., Jurado García JM; Department of Medical Oncology, San Cecilio University Hospital, Granada., Vélez de Mendizábal E; Department of Medical Oncology, San Pedro Hospital, Logroño., Lambea Sorrosal JJ; Department of Medical Oncology, Lozano Blesa University Hospital, Zaragoza., García Carbonero I; Department of Medical Oncology, Virgen de la Salud Hospital, Toledo., González del Alba A; Department of Medical Oncology, Son Espases University Hospital, Palma de Mallorca., Suárez Rodríguez C; Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona., Jiménez Gallego P; Department of Medical Oncology, Doctor Negrín University Hospital of Gran Canaria, Las Palmas de Gran Canaria., Meana García JA; Department of Medical Oncology, University Hospital of Alicante, Alicante., García Marrero RD; Department of Medical Oncology, University Hospital of Canarias, San Cristóbal de La Laguna (Santa Cruz de Tenerife)., Gajate Borau P; Department of Medical Oncology, Quirón University Hospital, Madrid., Santander Lobera C; Department of Medical Oncology, Miguel Servet University Hospital, Zaragoza., Molins Palau C; Department of Medical Oncology, Doctor Peset University Hospital, Valencia., López Brea M; Department of Medical Oncology, Marqués de Valdecilla University Hospital, Santander., Fernández Parra EM; Department of Medical Oncology, Nuestra Señora de Valme University Hospital, Sevilla., Reig Torras O; Department of Medical Oncology, Clinic University Hospital of Barcelona, Barcelona., Basterretxea Badiola L; Department of Medical Oncology, Donostia University Hospital, San Sebastián., Vázquez Estévez S; Department of Medical Oncology, Lucus Augusti University Hospital, Lugo., González Larriba JL; Department of Medical Oncology, San Carlos University Hospital, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2016 Apr; Vol. 27 (4), pp. 706-11. Date of Electronic Publication: 2015 Dec 09.
DOI:	10.1093/annonc/mdv601
Abstrakt:	Background: 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. Patients and Methods: 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. Results: 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. Conclusion: Our results validate the IMDC model for first-line pazopanib in mRCC and confirm the effectiveness and safety of this treatment. (© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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