Impact on clinical practice of the implementation of guidelines for the toxicity management of targeted therapies in kidney cancer. The protect-2 study

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.

BMC cancer. 2016 Feb 22*** epublish ***

Nuria Lainez, Jesús García-Donas, Emilio Esteban, Javier Puente, M Isabel Sáez, Enrique Gallardo, Álvaro Pinto-Marín, Sergio Vázquez-Estévez, Luis León, Icíar García-Carbonero, Cristina Suárez-Rodríguez, Carmen Molins, Miguel A Climent-Duran, Martín Lázaro-Quintela, Aranzazu González Del Alba, María José Méndez-Vidal, Isabel Chirivella, Francisco J Afonso, Marta López-Brea, Nuria Sala-González, Montserrat Domenech, Laura Basterretxea, Carmen Santander-Lobera, Irene Gil-Arnáiz, Ovidio Fernández, Cristina Caballero-Díaz, Begoña Mellado, David Marrupe, José García-Sánchez, Ricardo Sánchez-Escribano, Eva Fernández Parra, José C Villa Guzmán, Esther Martínez-Ortega, María Belén González, Marina Morán, Beatriz Suarez-Paniagua, María J Lecumberri, Daniel Castellano

Department of oncology, Complejo Hospitalario de Navarra, Servicio Oncología Médica. Pabellón B 2ª planta. Hospital de día, C/ Irunlarrea, 3, 31008, Pamplona, Navarra, Spain. Department of oncology, Hospital Sanchinarro, C/ Oña, 10, 28050, Madrid, Spain. Department of oncology, Hospital Universitario Central de Asturias, Julián Clavería s/n, 33006, Oviedo, Spain. Department of oncology, Hospital Clínico de Madrid, C/ Doctor Martín Lagos s/n, 28040, Madrid, Spain. Department of oncology, Hospital Universitario Clínico Virgen de la Victoria, Campus Universitario de Teatinos, s/n, 29010, Málaga, Spain. Department of oncology, Parc Taulí Sabadell Hospital Universitari, Parc Taulí 1, 08208, Sabadell, Spain. Department of oncology, Hospital Universitario La Paz, P de la Castellana 261, 28046, Madrid, Spain.  Department of oncology, Hospital Universitario Lucus Augusti, Lugar San Cibrao, S/N, 27003, Lugo, Spain. Department of oncology, Hospital Santiago de Compostela, Travesía da Choupana, s/n, 15706, Santiago de Compostela, Spain. Department of oncology, Hospital Virgen de la Salud, Adva. De Barber, 30, 45004, Toledo, Spain. Department of oncology, Hospital Vall d'Hebron, Ps Vall d'Hebron, 119-129, 8035, Barcelona, Spain. Department of oncology, Hospital Universitario Dr. Peset, Avda. Gaspar Aguilar 90, 46017, Valencia, Spain.  Department of oncology, Instituto Valenciano de Oncología, Gregorio Gea, 31-1° Planta, 46009, Valencia, Spain.  Department of oncology, Complexo Hospitalario Universitario de Vigo, Pizarro 22, 36204, Vigo, Spain.  Department of oncology, Hospital Universitario Son Espases, Ctra Valldemossa, 79, 07010, Palma de Mallorca, Spain. Department of oncology, Hospital Universitario Reina Sofía, Avda. Menéndez Pidal, s/n, 14004, Córdoba, Spain. Department of oncology, Hospital Clínico de Valencia, Avda Blasco Ibáñez, 17, 46010, Valencia, Spain. Department of oncology, Complejo Hospitalario Arquitecto Marcide, Rúa da residencia s/n. San pedro de Leixa, 15405, Ferrol, Spain.  Department of oncology, Hospital Marqués de Valdecilla, Avda. Valdecila s/n, 39008, Santander, Spain. Department of oncology, ICO de Girona, Francia s/n, 17007, Gerona, Spain. Department of oncology, Hospital de Althaia Xarxa Asistencial Manresa, Dr. Joan Soler, 1-3, 08243, Barcelona, Spain. Department of oncology, Hospital de Donostia, P° Dr. Beguiristain 109, 20014, San Sebastian, Spain. Department of oncology, Hospital Miguel Servet, Avda Gómez Laguna 25, 50009, Zaragoza, Spain. Department of oncology, Hospital Reina Sofía, Carretera Tarazona, KM 3, 31500, Tudela, Spain. Department of oncology, Complejo Hospitalario Ourense. Hospital Santa María Nai, Ramón Puga, 52-54, 32005, Orense, Spain. Department of oncology, Hospital General Universitario de Valencia, Avda Tres Cruces, s/n, 46014, Valencia, Spain. Department of oncology, IDIBAPS, Hospital Clinic i Provincial de Barcelona, Villarroel, 170, 08036, Barcelona, Spain. Department of oncology, Hospital Universitario de Móstoles, Río Júcar s/n, 28935, Móstoles, Madrid, Spain. Department of oncology, Hospital Arnau de Vilanova, C/ San Clemente n 12, 46015, Valencia, Spain. Department of oncology, Hospital Universitario de Burgos, Avenida Cid Campeador, 96, 09005, Burgos, Spain. Department of oncology, H.U. Hospital de Valme, Ctra. de Cádiz Km. 548.9, 41014, Sevilla, Spain.  Department of oncology, Hospital de Ciudad Real, Obispo Rafael Torija, 13005, Ciudad Real, Spain. Department of oncology, Hospital Ciudad de Jaén, Avenida Ejercito Español 10, 23007, Jaén, Spain. Department of oncology, Hospital Son Llatzer, Ctra. Manacor, km.4, Sont Frriol, 07198, Palma de Mallorca, Spain. Pfizer Madrid, Avda. de Europa, 20B, 28108, Alcobendas, Madrid, Spain.  Trial Form Support, Avda. de Europa, 20B, 28108, Alcobendas, Madrid, Spain.  Department of oncology, Complejo Hospitalario de Navarra, Servicio Oncología Médica. Pabellón B 2ª planta. Hospital de día, C/ Irunlarrea, 3, 31008, Pamplona, Navarra, Spain. Department of oncology, Hospital 12 de Octubre, Av. de Córdoba s/n, 28041, Madrid, Spain.