Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain : OSIREX-Spanish Lung Cancer Group
Provencio, Mariano (Universidad Autónoma de Madrid)
Terrasa, Josefa (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Garrido, Pilar (Instituto Ramón y Cajal de Investigación Sanitaria (Madrid))
Campelo, Rosario García (Instituto de Investigación Biomédica de A Coruña)
Aparisi, Francisco (Hospital General Universitario de Valencia)
Diz Taín, Pilar (Complejo Asistencial Universitario de León)
Aguiar, David (Hospital Universitario de Gran Canaria Dr. Negrín)
García-Giron, Carlos (Hospital Universitario de Burgos)
Hidalgo, Julia (Hospital Lluís Alcanyis. Medical Oncology Department)
Aguado, Carlos (Hospital Clínico San Carlos (Madrid))
González, Jorge García (Hospital Clínico Universitario (Santiago de Compostela, Galícia))
Esteban, Emilio (Hospital Universitario Central de Asturias)
Gómez-Aldavarí, Lorenzo (Complejo Hospitalario Universitario de Albacete)
Morán, Teresa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Juan, Óscar (Hospital Universitari i Politècnic La Fe (València))
Chara, Luís Enrique (Hospital Universitario de Guadalajara)
Marti, Juan L. (Hospital General Universitario de Alicante (Alacant, País Valencià))
Castro, Rafael López (Hospital Clínico Universitario de Valladolid)
Ortega Granados, Ana Laura (Complejo Hospitalario de Jaén)
Moreno, Elia Martínez (Hospital Virgen de la Salud (Toledo))
Coves, Juan (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Sánchez Peña, Ana M. (Hospital Universitario de Getafe (Madrid))
Bosch-Barrera, J (Hospital Universitari de Girona Doctor Josep Trueta)
Gastaldo, Amparo Sánchez (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Núñez, Natalia Fernández (Hospital Universitario Lucus Augusti (Lugo))
Del Barco Morillo, Edel (Hospital Universitario de Salamanca)
Cobo, Manuel (Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Unidad de Gestión Clínica Intercentros de Oncología Médica)
Isla, Dolores (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Majem, Margarita (Institut d'Investigació Biomèdica Sant Pau)
Navarro, Fátima (Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Madrid))
Calvo, Virginia (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Universitat Autònoma de Barcelona

Date:	2021
Abstract:	AURA study reported 61% objective response rate and progression-free survival of 9. 6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain. Post-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. One hundred-fifty five patients were enrolled (August 2016-December 2018) from 30 sites. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources. 70% women, median age 66. 63. 9% were non-smokers and 99% had adenocarcinoma. Most patients had received at least one prior treatment (97%), 91. 7% had received previous EGFR-tyrosine kinase inhibitors and 2. 8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11. 8 months. One hundred-fifty five patients were evaluable for response, 1. 3% complete response, 40. 6% partial response, 31% stable disease and 11. 6% disease progression. Objective response rate was 42%. Median progression-free survival was 9. 4 months. Of the 155 patients who received treatment, 76 (49%) did not reported any adverse event, 51% presented some adverse event, most of which were grade 1 or 2. The resource cost study indicates early use is warranted. This study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events. Clinical trial registration number : NCT03790397.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Osimertinib ; Real-world data ; EGFR-activating mutations ; T790M EGFR mutation ; Second line ; Non-small cell lung cancer
Published in:	BMC Cancer, Vol. 21 (march 2021) , ISSN 1471-2407

DOI: 10.1186/s12885-021-07922-5
PMID: 33676426

12 p, 700.5 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles