Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy

Conditions

Metastatic Renal Cell Carcinoma

Brief summary

The purpose of this retrospective observational study was to analyze the effect of targeted therapies administered as second-line treatment after failure of pazopanib as well as increase the amount of information available on efficacy and safety of pazopanib as a first-line therapy in practice usual for the clinical treatment of metastatic Renal Carcinoma.

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 García JA, 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, González Larriba JL.

2015-12-0923 citations

10.1093/annonc/mdv601

Validation of the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (IMRCC), in patients (pt) treated with pazopanib (Pz) as first line for metastatic renal carcinoma (mRC): First results of the SOGUG SPAZO study.

Begoña Pérez‐Valderrama, Jóse Ángel Arranz Arija, Pablo Borrega, Ángel Rodríguez Sánchez, Álvaro Pinto et al. (20 authors)

Journal of Clinical Oncology2015-05-20

10.1200/jco.2015.33.15_suppl.e15597

Interventions

DRUGPazopanib

Non interventional study

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients ≥ 18. * Metastatic renal cell cancer of any histology. * Patients treated with pazopanib for metastatic cell renal cancer outside the context of clinical trials (clinical practice) in Spanish centers from 1 April 2011 until 30 June 2014. shall be included all patients who received pazopanib as first-line treatment in each participating center, whether had experienced treatment failure with pazopanib or were still in first-line treatment. The inclusion of patients who are also allowed received cytokine as first-line treatment followed by pazopanib as well as patients who received sunitinib as first-line treatment and have changed pazopanib for toxicity or intolerance, provided they have not received more a cycle of sunitinib. * Centers that agree to participate must commit to: · Include all patients meeting the inclusion criteria to reduce by possible selection bias. Because it supplies only pazopanib Hospital pharmacy service (not outside hospitals), the identification of patients will be performed at the hospital pharmacy records in each participating center.

Exclusion criteria

* Patients who received pazopanib in clinical trials or treatment second line, with the exceptions noted above. * Patients with the diagnosis and / or treatment of malignancies of importance other than Cell renal cancer.

Design outcomes

Primary

Measure	Time frame	Description
Describe the efficacy in terms of response	3 years	Describe the efficacy in terms of response of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Describe the efficacy in terms of progression-free survival (PFS)	3 years	Describe the efficacy in terms of progression-free survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Describe the efficacy in terms of overall survival (OS)	3 years	Describe the efficacy in terms of overall survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).

Countries

Spain

Outcome results

None listed