1. Impact on clinical practice of the implementation of guidelines for the toxicity management of targeted therapies in kidney cancer. The protect-2 study
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O. Fernández, José García-Sánchez, Beatriz Suarez-Paniagua, Jose Carlos Villa Guzman, Carmen Santander-Lobera, Núria Sala-González, Miguel A. Climent-Duran, Montserrat Domenech, Nuria Lainez, Sergio Vazquez-Estevez, Enrique Gallardo, Marina Morán, Javier Puente, Martín Lázaro-Quintela, Cristina Caballero-Díaz, Emilio Esteban, Carmen Molins, Alvaro Pinto-Marin, F.J. Afonso, Maria Jose Lecumberri, Laura Basterretxea, Ricardo Sánchez-Escribano, Daniel Castellano, María Belén González, Iciar García-Carbonero, Marta López-Brea, Isabel Chirivella, Esther Martínez-Ortega, David Marrupe, M Isabel Sáez, Aranzazu Gonzalez del Alba, Irene Gil-Arnaiz, Begoña Mellado, Cristina Suárez-Rodríguez, Eva Fernandez Parra, Jesús García-Donas, María José Méndez-Vidal, Luis León, [Lainez,N, Lecumberri,MJ] Department of oncology, Complejo Hospitalario de Navarra, Servicio Oncología Médica, Navarra, Spain, [García-Doñas,J] Hospital Sanchinarro, Departamento Oncología, Spain, [Esteban,E] Hospital Universitario Central de Asturias, Departamento de Oncología, Oviedo, Spain, [Puente,J] Hospital Clínico de Madrid, Departamento de Oncología, Madrid, Spain, [Sáez, MI] Hospital Universitario Clínico Virgen de la Victoria, Departamento de Oncología, Málaga, Spain, [Gallardo,E] Parc Tauli Sabadell Hospital Universitario, Departamento de Oncología, Sabadell, Spain, [Pinto-Marín,A] Hospital Universitario La Paz, Departamento de Oncología, Madrid, Spain, [Vázquez-Estévez,S] Hospital Universitario Lucus Augusti, Departamento de Oncología, Lugo, Spain, [León,L] Hospital Santiago de Compostela, Departamento de Oncología, Santiago de Compostela, Spain, [García-Carbonero,I] Hospital Virgen de la Salud, Departamento de Oncología, Toledo, Spain, [Suárez-Rodríguez,C] Hospital Valle de Hebrón, Departamento de Oncología, Barcelona, Spain, [Molins,C] Hospital Universitario Dr. Peset, Departamento de Oncología, Valencia, Spain, [Climent-Durán,MA] Instituto Valenciano de Oncología, Departamento de Oncología, Valencia, Spain, [Lázaro-Quintela,M] Complexo Hospitalario Universitario de Vigo, Departamento de Oncología, Vigo, Spain, [González del Alba,A] Hospital Universitario Son Espases, Departamento de Oncología, Palma de Mallorca, Spain, [Méndez-Vidal,MJ] Hospital Universitario Reina Sofía, Departamento de Oncología, Córdoba, Spain, [Chirivella,I] Hospital Clínico de Valencia, Departamento Oncología, Valencia, Spain, [Afonso,FJ] Complejo Hospitalario Arquitecto Marcide, Departamento de Oncología, Ferrol, Spain, [López-Brea,M] Hospital Marqués de Valdecilla, Departamento de Oncología, Santander, Spain, [Sala-González,N] ICO Girona, Departamento de Oncología, Girona, Spain, [Domenech,M] Hospital Althaia Xarxa Asistencial Manresa, Departamento de Oncología, Barcelona, Spain, [Basterretxea,L] Hospital Donostia, Departamento de Oncología, San Sebastián, Spain, [Santander-Lobera,C] Hospital Miguel Servet, Departamento de Oncología, Zaragoza, Spain, [Gil-Arnáiz,I] Hospital Reina Sofía, Departamento Oncología, Tudela, Spain, [Fernández,O] Hospital Santa María Nai, Complejo Hospital Ourense, Departamento de Oncología, Orense, Spain, [Caballero-Díaz,C] Hospital Gen Universitario Valencia, Departamento de Oncología, Valencia, Spain, [Mellado,B] Hospital Clinic de Barcelona, Departamento de Oncología, IDIBAPS, Barcelona, Spain, [Marrupe,D] Hospital Universitario de Móstoles, Departamento de Oncología, Madrid, Spain, [García-Sánchez,J] Hospital Arnau Vilanova, Departamento de Oncología, Valencia, Spain, [Sánchez-Escribano,R] Hospital Universitario de Burgos, Departamento de Oncología, Burgos, Spain, [Fernández Parra,E] Hospital Universitario de Valme, Departamento de Oncología, Sevilla, Spain, [Villa Guzmán,JC] Hospital de Ciudad Real, Departamento de Oncología, Ciudad Real, Spain, [Martínez-Ortega,E] Hospital Ciudad de Jaén, Departamento de Oncología, Jaén, Spain, [González,MB] Hospital Son Llatzer, Departamento de Oncología, Palma de Mallorca, Spain, [Morán,M] Pfizer Madrid, Spain, [Suárez-Paniagua,B] Trial Form Support, Madrid, Spain, [Castellano,D] Hospital 12 Octubre, Departamento de Oncología, Madrid, Spain., and This study was funded by Pfizer, S.L.U. Medical writing assistance was provided by Esther Tapia, PhD and was founded by Pfizer.
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0301 basic medicine ,Male ,Cancer Research ,Diseases::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms [Medical Subject Headings] ,medicine.medical_treatment ,humanos ,Neoplasias renales ,urologic and male genital diseases ,Health Care::Health Services Administration::Patient Care Management::Disease Management [Medical Subject Headings] ,Targeted therapy ,Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] ,0302 clinical medicine ,guías de práctica clínica como asunto ,Renal cell carcinoma ,Surgical oncology ,antineoplásicos ,Molecular Targeted Therapy ,Neoplasm Metastasis ,metástasis neoplásica ,mediana edad ,anciano ,Health Care::Health Care Quality, Access, and Evaluation::Delivery of Health Care::Attitude to Health::Patient Acceptance of Health Care::Patient Compliance [Medical Subject Headings] ,Middle Aged ,Kidney Neoplasms ,Humanos ,Oncology ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,Diseases::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms::Carcinoma, Renal Cell [Medical Subject Headings] ,terapia molecular selectiva ,Female ,Guideline Adherence ,Research Article ,medicine.medical_specialty ,Antineoplastic Agents ,Guidelines ,03 medical and health sciences ,Diseases::Cardiovascular Diseases::Vascular Diseases::Hypertension [Medical Subject Headings] ,Internal medicine ,Hipertensión ,Carcinoma ,medicine ,Genetics ,Humans ,Cooperación del paciente ,Adverse effect ,Carcinoma, Renal Cell ,Aged ,neoplasias renales ,Genitourinary system ,business.industry ,Renal Cell Carcinoma ,Carcinoma de células renales ,Guideline ,medicine.disease ,Surgery ,030104 developmental biology ,Spain ,Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Diarrhea [Medical Subject Headings] ,Adverse events ,business ,Diarrea ,Kidney cancer - Abstract
Background: The impact of such recommendations after their implementation of guidelines has not usually been evaluated. Herein, we assessed the impact and compliance with the Spanish Oncology Genitourinary Group (SOGUG) Guidelines for toxicity management of targeted therapies in metastatic renal cell carcinoma (mRCC) in daily clinical practice. Methods: Data on 407 mRCC patients who initiated first-line targeted therapy during the year before and the year after publication and implementation of the SOGUG guideline program were available from 34 Spanish Hospitals. Adherence to SOGUG Guidelines was assessed in every cycle. Results: Adverse event (AE) management was consistent with the Guidelines as a whole for 28.7 % out of 966 post-implementation cycles compared with 23.1 % out of 892 pre-implementation cycles (p = 0.006). Analysis of adherence by AE in non-compliant cycles showed significant changes in appropriate management of hypertension (33 % pre-implementation vs. 44.5 % post-implementation cycles; p < 0.0001), diarrhea (74.0 % vs. 80.5 %; p = 0.011) and dyslipemia (25.0 % vs. 44.6 %; p < 0.001). Conclusions: Slight but significant improvements in AE management were detected following the implementation of SOGUG recommendations. However, room for improvement in the management of AEs due to targeted agents still remains and could be the focus for further programs in this direction., This study was funded by Pfizer, S.L.U. Medical writing assistance was provided by Esther Tapia, PhD and was founded by Pfizer. The authors gratefully say thanks to Ma Luz Samaniego for his help with the statistical analyses.
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- 2016