Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies

Background: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon- in metastatic renal cell carcinoma (mRCC) patients. Objective: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clin...

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Autores: Castellano, D, Maroto, JP, Espinosa, E, Grande, E, Bolos, MV, Llinares, J, Esteban, E, del Alba, AG, Climent, MA, Arranz, JA, Mendez, MJ, Parra, EF, Anton-Aparicio, L, Bayona, C, Gallegos, I, Gallardo, E, Samaniego, L, Donas, JG
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p3684
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3684
http://hdl.handle.net/2183/28112
Access Level:acceso abierto
Palabra clave:Effectiveness
routine clinical practice
safety
sunitinib
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spelling Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studiesCastellano, DMaroto, JPEspinosa, EGrande, EBolos, MVLlinares, JEsteban, Edel Alba, AGCliment, MAArranz, JAMendez, MJParra, EFAnton-Aparicio, LBayona, CGallegos, IGallardo, ESamaniego, LDonas, JGEffectivenessroutine clinical practicesafetysunitinibBackground: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon- in metastatic renal cell carcinoma (mRCC) patients. Objective: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice. Methods: Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals. Tumor response, Progression-free survival (PFS) and overall survival (OS), and main sunitinib-related toxicities were registered. Results: 224 patients were analyzed. Median PFS 10.6 months (95% CI: 9.02-12.25), median OS 21.9 months (95% CI: 17.2-26.6). Objective response rate (ORR) 43.8% (95% CI: 36.8-50.7). Median time to PR was 3.8 months (95% CI: 3.86-5.99) and to CR 8.2 months (95% CI: 4.75-9.77). The most common >= grade-3 AEs were asthenia/fatigue (18.7%), hand-foot syndrome (6.2%), hypertension (5.8%) and neutropenia (4.8%). Hand-foot syndrome, diarrhea and mucositis were confirmed as independent predictors for PFS and/or OS in a multivariate analysis (p < 0.05) Conclusions: Outcomes with sunitinib in daily clinical practice resemble those obtained in clinical trials. Long-term benefit with sunitinib is possible in advanced RCC patients but the appropriate management of toxicities is mandatory to enable patients to remain on treatment.TAYLOR & FRANCIS LTD2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3684http://hdl.handle.net/2183/28112Expert Opinion On Drug SafetyISSN: 14740338ISSNe: 1744764Xreponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p36842026-06-14T12:41:47Z
dc.title.none.fl_str_mv Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
title Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
spellingShingle Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
Castellano, D
Effectiveness
routine clinical practice
safety
sunitinib
title_short Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
title_full Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
title_fullStr Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
title_full_unstemmed Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
title_sort Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies
dc.creator.none.fl_str_mv Castellano, D
Maroto, JP
Espinosa, E
Grande, E
Bolos, MV
Llinares, J
Esteban, E
del Alba, AG
Climent, MA
Arranz, JA
Mendez, MJ
Parra, EF
Anton-Aparicio, L
Bayona, C
Gallegos, I
Gallardo, E
Samaniego, L
Donas, JG
author Castellano, D
author_facet Castellano, D
Maroto, JP
Espinosa, E
Grande, E
Bolos, MV
Llinares, J
Esteban, E
del Alba, AG
Climent, MA
Arranz, JA
Mendez, MJ
Parra, EF
Anton-Aparicio, L
Bayona, C
Gallegos, I
Gallardo, E
Samaniego, L
Donas, JG
author_role author
author2 Maroto, JP
Espinosa, E
Grande, E
Bolos, MV
Llinares, J
Esteban, E
del Alba, AG
Climent, MA
Arranz, JA
Mendez, MJ
Parra, EF
Anton-Aparicio, L
Bayona, C
Gallegos, I
Gallardo, E
Samaniego, L
Donas, JG
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Effectiveness
routine clinical practice
safety
sunitinib
topic Effectiveness
routine clinical practice
safety
sunitinib
description Background: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon- in metastatic renal cell carcinoma (mRCC) patients. Objective: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice. Methods: Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals. Tumor response, Progression-free survival (PFS) and overall survival (OS), and main sunitinib-related toxicities were registered. Results: 224 patients were analyzed. Median PFS 10.6 months (95% CI: 9.02-12.25), median OS 21.9 months (95% CI: 17.2-26.6). Objective response rate (ORR) 43.8% (95% CI: 36.8-50.7). Median time to PR was 3.8 months (95% CI: 3.86-5.99) and to CR 8.2 months (95% CI: 4.75-9.77). The most common >= grade-3 AEs were asthenia/fatigue (18.7%), hand-foot syndrome (6.2%), hypertension (5.8%) and neutropenia (4.8%). Hand-foot syndrome, diarrhea and mucositis were confirmed as independent predictors for PFS and/or OS in a multivariate analysis (p < 0.05) Conclusions: Outcomes with sunitinib in daily clinical practice resemble those obtained in clinical trials. Long-term benefit with sunitinib is possible in advanced RCC patients but the appropriate management of toxicities is mandatory to enable patients to remain on treatment.
publishDate 2018
dc.date.none.fl_str_mv 2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3684
http://hdl.handle.net/2183/28112
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=3684
http://hdl.handle.net/2183/28112
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv TAYLOR & FRANCIS LTD
publisher.none.fl_str_mv TAYLOR & FRANCIS LTD
dc.source.none.fl_str_mv Expert Opinion On Drug Safety
ISSN: 14740338
ISSNe: 1744764X
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812429

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