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

被引：31

作者：

Perez-Valderrama, B. ^{[1
]}

Arranz Arija, J. A. ^{[2
]}

Rodriguez Sanchez, A. ^{[3
]}

Pinto Marin, A. ^{[4
]}

Borrega Garcia, P. ^{[5
]}

Castellano Gaunas, D. E. ^{[6
]}

Rubio Romero, G. ^{[7
]}

Maximiano Alonso, C. ^{[8
]}

Villa Guzman, J. C. ^{[9
]}

Puertas Alvarez, J. L. ^{[10
]}

Chirivella Gonzalez, I. ^{[11
]}

Mendez Vidal, M. J. ^{[12
]}

Juan Fita, M. J. ^{[13
]}

Leon-Mateos, L. ^{[14
]}

Lazaro Quintela, M. ^{[15
]}

Garcia Dominguez, R. ^{[16
]}

Jurado Garcia, J. M. ^{[17
]}

Velez de Mendizabal, E. ^{[18
]}

Lambea Sorrosal, J. J. ^{[19
]}

Garcia Carbonero, I. ^{[20
]}

Gonzalez del Alba, A. ^{[21
]}

Suarez Rodriguez, C. ^{[22
]}

Jimenez Gallego, P. ^{[23
]}

Meana Garcia, J. A. ^{[24
]}

Garcia Marrero, R. D. ^{[25
]}

Gajate Borau, P. ^{[26
]}

Santander Lobera, C. ^{[27
]}

Molins Palau, C. ^{[28
]}

Lopez Brea, M. ^{[29
]}

Fernandez Parra, E. M. ^{[30
]}

Reig Torras, O. ^{[31
]}

Basterretxea Badiola, L. ^{[32
]}

Vazquez Estevez, S. ^{[33
]}

Gonzalez Larriba, J. L. ^{[34
]}

机构：

[1] Virgen Rocio Univ Hosp, Dept Med Oncol, Manuel Siurot S-N, Seville 41013, Spain

[2] Gregorio Maranon Gen Univ Hosp, Dept Med Oncol, Madrid, Spain

[3] Univ Hosp Leon, Dept Med Oncol, Leon, Spain

[4] La Paz Univ Hosp, Dept Med Oncol, Madrid, Spain

[5] San Pedro Alcantara Hosp, Dept Med Oncol, Caceres, Spain

[6] 12 Octubre Univ Hosp, Dept Med Oncol, Madrid, Spain

[7] Fdn Jimenez Diaz Univ Hosp, Dept Med Oncol, Madrid, Spain

[8] Puerta Hierro Univ Hosp, Dept Med Oncol, Madrid, Spain

[9] Gen Univ Hosp Ciudad Real, Dept Med Oncol, Ciudad Real, Spain

[10] Rio Hortega Univ Hosp, Dept Med Oncol, Valladolid, Spain

[11] Univ Hosp Valencia, Dept Med Oncol, Valencia, Spain

[12] Reina Sofia Univ Hosp, Dept Med Oncol, Cordoba, Spain

[13] Valencian Inst Oncol, Dept Med Oncol, Valencia, Spain

[14] Univ Santiago, Dept Med Oncol, Hosp Complex, Santiago De Compostela, Spain

[15] Dept Med Oncol, Univ Hosp Complex Vigo, Vigo, Spain

[16] Clin Univ Hosp Salamanca, Dept Med Oncol, Salamanca, Spain

[17] San Cecilio Univ Hosp, Dept Med Oncol, Granada, Spain

[18] San Pedro Hosp, Dept Med Oncol, Logrono, Spain

[19] Lozano Blesa Univ Hosp, Dept Med Oncol, Zaragoza, Spain

[20] Virgen Salud Hosp, Dept Med Oncol, Toledo, Spain

[21] Son Espases Univ Hosp, Dept Med Oncol, Palma de Mallorca, Spain

[22] Vall dHebron Univ Hosp, Dept Med Oncol, Barcelona, Spain

[23] Doctor Negrin Univ Hosp Gran Canaria, Dept Med Oncol, Las Palmas Gran Canaria, Spain

[24] Hosp Gen Univ Alicante, Dept Med Oncol, Alicante, Spain

[25] Univ Hosp Canarias, Dept Med Oncol, San Cristobal La Laguna, Santa Cruz De T, Spain

[26] Quiron Univ Hosp, Dept Med Oncol, Madrid, Spain

[27] Miguel Servet Univ Hosp, Dept Med Oncol, Zaragoza, Spain

[28] Doctor Peset Univ Hosp, Dept Med Oncol, Valencia, Spain

[29] Marques Valdecilla Univ Hosp, Dept Med Oncol, Santander, Spain

[30] Nuestra Senora Valme Univ Hosp, Dept Med Oncol, Seville, Spain

[31] Clin Univ Hosp Barcelona, Dept Med Oncol, Barcelona, Spain

[32] Donostia Univ Hosp, Dept Med Oncol, San Sebastian, Spain

[33] Lucus Augusti Univ Hosp, Dept Med Oncol, Lugo, Spain

[34] San Carlos Univ Hosp, Dept Med Oncol, Madrid, Spain

来源：

ANNALS OF ONCOLOGY | 2016年 / 27卷 / 04期

关键词：

metastatic renal cell cancer; pazopanib; prognostic classification; tyrosine kinase inhibitors; BLIND PHASE-III; INTERFERON-ALPHA; SUNITINIB; SURVIVAL; TRIAL; THERAPIES; SAFETY;

D O I：

10.1093/annonc/mdv601

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：706 / 711

页数：6

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