B Pérez-Valderrama1, J A Arranz Arija2, A Rodríguez Sánchez3, A Pinto Marín4, P Borrega García5, D E Castellano Gaunas6, G Rubio Romero7, C Maximiano Alonso8, J C Villa Guzmán9, J L Puertas Álvarez10, I Chirivella González11, M J Méndez Vidal12, M J Juan Fita13, L León-Mateos14, M Lázaro Quintela15, R García Domínguez16, J M Jurado García17, E Vélez de Mendizábal18, J J Lambea Sorrosal19, I García Carbonero20, A González del Alba21, C Suárez Rodríguez22, P Jiménez Gallego23, J A Meana García24, R D García Marrero25, P Gajate Borau26, C Santander Lobera27, C Molins Palau28, M López Brea29, E M Fernández Parra30, O Reig Torras31, L Basterretxea Badiola32, S Vázquez Estévez33, J L González Larriba34. 1. Department of Medical Oncology, Virgen del Rocío University Hospitals, Sevilla bperezv@gmail.com. 2. Department of Medical Oncology, Gregorio Marañón General University Hospital, Madrid. 3. Department of Medical Oncology, University Hospital of León, Leon. 4. Department of Medical Oncology, La Paz University Hospital, Madrid. 5. Department of Medical Oncology, San Pedro de Alcántara Hospital, Cáceres. 6. Department of Medical Oncology, 12 de Octubre University Hospital, Madrid. 7. Department of Medical Oncology, Fundación Jiménez Díaz University Hospital, Madrid. 8. Department of Medical Oncology, Puerta de Hierro University Hospital, Majadahonda (Madrid). 9. Department of Medical Oncology, General University Hospital of Ciudad Real, Ciudad Real. 10. Department of Medical Oncology, Rio Hortega University Hospital, Valladolid. 11. Department of Medical Oncology, University Hospital of Valencia, Valencia. 12. Department of Medical Oncology, Reina Sofía University Hospital, Córdoba. 13. Department of Medical Oncology, Valencian Institute of Oncology, Valencia. 14. Department of Medical Oncology, Santiago University Hospital Complex, Santiago de Compostela. 15. Department of Medical Oncology, University Hospital Complex of Vigo, Vigo. 16. Department of Medical Oncology, Clinic University Hospital of Salamanca, Salamanca. 17. Department of Medical Oncology, San Cecilio University Hospital, Granada. 18. Department of Medical Oncology, San Pedro Hospital, Logroño. 19. Department of Medical Oncology, Lozano Blesa University Hospital, Zaragoza. 20. Department of Medical Oncology, Virgen de la Salud Hospital, Toledo. 21. Department of Medical Oncology, Son Espases University Hospital, Palma de Mallorca. 22. Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona. 23. Department of Medical Oncology, Doctor Negrín University Hospital of Gran Canaria, Las Palmas de Gran Canaria. 24. Department of Medical Oncology, University Hospital of Alicante, Alicante. 25. Department of Medical Oncology, University Hospital of Canarias, San Cristóbal de La Laguna (Santa Cruz de Tenerife). 26. Department of Medical Oncology, Quirón University Hospital, Madrid. 27. Department of Medical Oncology, Miguel Servet University Hospital, Zaragoza. 28. Department of Medical Oncology, Doctor Peset University Hospital, Valencia. 29. Department of Medical Oncology, Marqués de Valdecilla University Hospital, Santander. 30. Department of Medical Oncology, Nuestra Señora de Valme University Hospital, Sevilla. 31. Department of Medical Oncology, Clinic University Hospital of Barcelona, Barcelona. 32. Department of Medical Oncology, Donostia University Hospital, San Sebastián. 33. Department of Medical Oncology, Lucus Augusti University Hospital, Lugo. 34. Department of Medical Oncology, San Carlos University Hospital, Madrid, Spain.
Abstract
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.
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.
Authors: M Lázaro; B P Valderrama; C Suárez; G de-Velasco; C Beato; I Chirivella; A González-Del-Alba; N Laínez; M J Méndez-Vidal; J A Arranz Journal: Clin Transl Oncol Date: 2020-01-28 Impact factor: 3.405