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Poster display session

1907 - SPAZO2 (SOGUG): Comparative effectiveness of pazopanib in metastatic renal carcinoma (mRC): ineligible (I) vs eligible (E) patients for clinical trials.

Date

10 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Renal Cell Cancer

Presenters

Jose Arranz Arija

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

J. Arranz Arija1, B. Pérez Valderrama2, Á. Rodríguez Sánchez3, I. Chirivella González4, U. Anido Herranz5, J.P. Maroto Rey6, M.J. Miranda Pallares7, M.A. Climent Duran8, G. Crespo Herrero9, J.A. Meana Garcia10, A. Rodriguez-Vida11, R. Fernandez-Rodriguez12, C. Santander13, G. Rubio Romero14, S. Vazquez Estevez15, O. Fernandez Calvo16, M.B. Gonzalez Gragera17, E. Almagro Casado18, S. Perez Ramirez1, P. Borrega García19

Author affiliations

  • 1 Medical Oncology, Hospital General Universitario Gregorio Marañon, 28007 - Madrid/ES
  • 2 Medical Oncology, HH Virgen del Rocío, Sevilla/ES
  • 3 Medical Oncology, Complejo Asistencial Universitario de Leon, 24071 - Leon/ES
  • 4 Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 5 Medical Oncology, Hospital Clinico Universitario de Santiago de Compostela, 15706 - Santiago de Compostela/ES
  • 6 Medical Oncology, Hospital de la Santa Creu i Sant Pau, 8026 - Barcelona/ES
  • 7 Medical Oncology, Hospital Universitari Sant Joan de Reus, 43204 - Reus/ES
  • 8 Medical Oncology, Fundación Instituto Valenciano de Oncología, 46009 - Valencia/ES
  • 9 Medical Oncology, Hospital Universitario de Burgos, 9006 - Burgos/ES
  • 10 Medical Oncology, Hospital General Universitario de Alicante, 3010 - Alicante/ES
  • 11 Medical Oncology, University Hospital del Mar, 8003 - Barcelona/ES
  • 12 Medical Oncology, Instituto Oncológico IMQ Bilbao, 48014 - Bilbao/ES
  • 13 Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 14 Medical Oncology, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 15 Medical Oncology, Hospital Universitario Lucus Augusti, 27003 - Lugo/ES
  • 16 Medical Oncology, Complejo Hospitalario Universitario de Ourense, 32005 - Ourense/ES
  • 17 Medical Oncology, Hospital Son Llatzer, 07198 - Palma de Mallorca/ES
  • 18 Medical Oncology, Hospital Universitario Quirón Salud, Madrid/ES
  • 19 Medical Oncology, H. San Pedro de Alcántara, Cáceres/ES
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Resources

Abstract 1907

Background

Ineligibility for clinical trials (CT) may be an unfavorable prognostic factor in mRC. There is no information about the effectiveness of pazopanib in patients (pt) ineligible for CT. We aimed to assess the effect of ineligibility in outcomes in mRC, and the effectiveness of pazopanib in this setting.

Methods

SPAZO2 (NCT03091465) was a retrospective real-world study to analyze the effectiveness of 1st-line pazopanib and subsequent therapies in mRC in several settings. Data from 530 pt treated with frontline pazopanib outside CT in 50 centers in Spain were collected, and externally monitored. Ineligibility criteria: ECOG >1, pure nonclear-cell, brain metastases, Hgb 80 y, stroke, chronic liver disease, or recent neoplasia.

Results

A total of 217 pt (40.9%) fulfilled criteria for ineligibility. There were significant differences (I vs E) in age >75 (39% vs 15%), nephrectomy (61% vs 78%), IMDC (favorable: 8.8% vs 17.9%, intermediate: 50.2% vs 68.4%, poor: 41% vs 13.7%), metastases (lymph nodes: 51% vs 41%, lung: 65% vs 72%, liver: 21% vs 15%, bone: 31% vs 22%, skin/soft-tissue: 30% vs 16%, and CNS (13% vs 0%) but no in sex (68% vs 67% males). Discontinuation due to toxicity or comorbidities was 19% vs 17%. There were also differences (p 

Conclusions

In our series, “real world eligible pt” had similar outcome to the obtained in clinical trials. On the contrary, “real world ineligible pt” for clinical trials had significantly lower response rate, and shorter PFS and OS than elegible pt. Pazopanib was safe and effective in both subpopulations of patients.

Clinical trial identification

NCT03091465

Legal entity responsible for the study

SOGUG

Funding

Novartis

Disclosure

J. Arranz Arija: Grant for research from Novartis. Participation in advisory boards for Novartis and Pfizer. B. Pérez Valderrama: Consulting/Advisory role for Astellas Pharma, Novartis, Pfizer, Pierre Fabre, Bayer, Sanofi, Bristol-Myers Squib and Roche. J.P. Maroto Rey: Advisory Board for Novartis, Pfizer, Ibsen and Bristol. M.A. Climent Duran: Pfizer and Novartis talks, advisory role for Pfizer. All other authors have declared no conflicts of interest.

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