1. 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
- Author
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A. González del Alba, J.L. González Larriba, G. Rubio Romero, B. Pérez-Valderrama, J.L. Puertas Álvarez, D.E. Castellano Gaunas, R. García Domínguez, J. J. Garcia, S. Vazquez Estevez, C. Santander Lobera, J.A. Meana García, C. Molins Palau, R.D. García Marrero, M. López Brea, O. Reig Torras, M. Lázaro Quintela, I. García Carbonero, E.M. Fernandez Parra, L. Basterretxea Badiola, P. Gajate Borau, C. Maximiano Alonso, J.J. Lambea Sorrosal, J.C. Villa Guzman, J.A. Arranz Arija, E. Vélez de Mendizábal, M.J. Juan Fita, C. Suarez Rodriguez, P. Jiménez Gallego, Á. Rodríguez Sánchez, L. León-Mateos, A. Pinto Marin, M.J. Mendez Vidal, P. Borrega García, and I. Chirivella Gonzalez
- Subjects
Adult ,Male ,medicine.medical_specialty ,Indazoles ,Databases, Factual ,Population ,Urology ,Kaplan-Meier Estimate ,Disease-Free Survival ,Pazopanib ,03 medical and health sciences ,0302 clinical medicine ,Renal cell carcinoma ,Risk Factors ,tyrosine kinase inhibitors ,medicine ,pazopanib ,Humans ,030212 general & internal medicine ,Molecular Targeted Therapy ,education ,Lymph node ,Carcinoma, Renal Cell ,Aged ,Retrospective Studies ,Kidney ,education.field_of_study ,Sulfonamides ,metastatic renal cell cancer ,Genitourinary system ,business.industry ,Retrospective cohort study ,Hematology ,Middle Aged ,medicine.disease ,Prognosis ,Confidence interval ,Surgery ,medicine.anatomical_structure ,Pyrimidines ,Oncology ,Spain ,030220 oncology & carcinogenesis ,Female ,business ,prognostic classification ,medicine.drug - Abstract
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.
- Published
- 2016