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
Por:
Pérez-Valderrama B, Arranz Arija JA, Rodríguez Sánchez A, Pinto Marín A, Borrega García P, Castellano Gaunas DE, Rubio Romero G, Maximiano Alonso C, Villa Guzmán JC, Puertas Álvarez JL, Chirivella González I, Méndez Vidal MJ, Juan Fita MJ, León-Mateos L, Lázaro Quintela M, García Domínguez R, Jurado García JM, Vélez de Mendizábal E, Lambea Sorrosal JJ, García Carbonero I, González Del Alba A, Suárez Rodríguez C, Jiménez Gallego P, Meana J, García Marrero RD, Gajate Borau P, Santander Lobera C, Molins Palau C, López Brea M, Fernández Parra EM, Reig Torras O, Basterretxea Badiola L, Vázquez Estévez S and González Larriba JL
Publicada:
1 abr 2016
Ahead of Print:
9 dic 2015
Resumen:
The International Metastatic Renal-Cell Carcinoma Database Consortium prognostic classification for patients treated with first-line tyrosine kinase inhibitors did not include patients treated with pazopanib. A validation for this subset is presented in a nation-wide multicenter observational and externally monitored trial (SPAZO), which included 278 patients treated with first-line pazopanib.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.
Filiaciones:
Pérez-Valderrama B:
Department of Medical Oncology, Virgen del Rocío University Hospitals, Sevilla
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 J:
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
:
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
Open Access
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