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1. Randomized Phase III Trial of Erlotinib versus Docetaxel in Patients with Advanced Squamous Cell Non-Small Cell Lung Cancer Failing First-Line Platinum-Based Doublet Chemotherapy Stratified by VeriStrat Good versus VeriStrat Poor. The European Thoracic Oncology Platform (ETOP) EMPHASIS-lung Trial

Author

Peters S, Stahel RA, Dafni U, Ponce Aix S, Massutí B, Gautschi O, Coate L, López Martín A, van Heemst R, Berghmans T, Meldgaard P, Cobo Dols M, Garde Noguera J, Curioni-Fontecedro A, Rauch D, Mark MT, Cuffe S, Biesma B, van Henten AMJ, Juan Vidal Ó, Palmero Sanchez R, Villa Guzmán JC, Collado Martin R, Peralta S, Insa A, Summers Y, Láng I, Horgan A, Ciardiello F, de Hosson S, Pieterman R, Groen HJM, van den Berg PM, Zielinski CC, Chittazhathu Kurian Kuruvilla Y, Gasca-Ruchti A, Kassapian M, Novello S, Torri V, Tsourti Z, Gregorc V, Smit EF, EMPHASIS-lung Collaborative Group, Pulmonary medicine, CCA - Cancer Treatment and quality of life, Peters, S, Stahel, Ra, Dafni, U, Aix, Sp, Massutí, B, Gautschi, O, Coate, L, López Martín, A, Van Heemst, R, Berghmans, T, Meldgaard, P, Cobo Dols, M, Noguera, Jg, Curioni Fontecedro, A, Rauch, D, Mark, Mt, Cuffe, S, Biesma, B, Van Henten, Am, Vidal, Ój, Sanchez, Rp, Villa Guzmán, Jc, Martin, Rc, Peralta, S, Insa, A, Summers, Y, Láng, I, Horgan, A, Ciardiello, Fortunato, De Hosson, S, Pieterman, R, Groen, Hj, Van Den Berg, Pm, Zielinski, Cc, Kuruvilla, Yc, Gasca Ruchti, A, Kassapian, M, Novello, S, Torri, V, Tsourti, Z, Gregorc, V, Smit, Ef, and EMPHASIS lung collaborative, Group

Subjects
Oncology, Male, Lung Neoplasms, medicine.medical_treatment, Docetaxel, NSCLC, THERAPY, Squamous, Cohort Studies, RETROSPECTIVE ANALYSIS, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, 3RD-LINE, Antineoplastic Combined Chemotherapy Protocols, VeriStrat, 030212 general & internal medicine, Erlotinib Hydrochloride, ETOP, Prognosis, Survival Rate, Erlotinib, 030220 oncology & carcinogenesis, Carcinoma, Squamous Cell, Female, Taxoids, Veristrat, 2ND-LINE TREATMENT, medicine.drug, Pulmonary and Respiratory Medicine, medicine.medical_specialty, 03 medical and health sciences, Internal medicine, Multicenter trial, medicine, TYROSINE KINASE INHIBITORS, Journal Article, Humans, Lung cancer, COMBINATION, Survival rate, neoplasms, METAANALYSIS, Aged, Neoplasm Staging, Platinum, Chemotherapy, business.industry, medicine.disease, respiratory tract diseases, business, GROWTH-FACTOR RECEPTOR, Follow-Up Studies
Abstract

Introduction: Docetaxel and erlotinib are registered second line treatments for wild-type EGFR NSCLC. Previous studies suggested a predictive value of the VeriStrat test in second line therapy of NSCLC, classifying patients as either VeriStrat good or VeriStrat poor. EMPHASIS-lung aimed at exploring this predictive effect in patients with squamous cell NSCLC. The trial closed prematurely because of low accrual and results from other trials. Our analysis includes an exploratory combined analysis with results from the PROSE trial.Methods: EMPHASIS-lung was a randomized phase III multicenter trial exploring the differential effect of second line erlotinib versus docetaxel on progression-free survival (PFS) in VeriStrat good versus VeriStrat poor patients with squamous cell NSCLC.Results: A total of 80 patients were randomized, with 72.5% categorized as VeriStrat good. Patient characteristics were balanced between VeriStrat status and treatment groups. The median PFS times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 4.1 and 1.6 months, respectively, versus 1.9 and 2.1 months, respectively, in the VeriStrat poor cohort. The median overall survival (OS) times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 7.8 and 8.4 months, respectively, and 4.4 and 5.2 months, respectively, in the VeriStrat poor cohort. An additional exploratory analysis was performed; in it, 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis, contributing with 45 PFS and 41 OS events.Conclusions: The final analysis of EMPHASIS-lung did not show a differential effect on PFS for erlotinib versus docetaxel stratified by VeriStrat status. Similarly, in the combined analysis, no significant treatment by VeriStrat status interaction was observed (interaction p=0.24 for PFS and 0.45 for OS, stratified by study). (C) 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Published
2016

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

Author

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.

Subjects
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.

Published
2016

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