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

BackgroundAURA study reported 61% objective response rate and progression-free survival of 9.6months 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.MethodsPost-autho...

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Detalles Bibliográficos
Autores: Provencio, M, Terrasa, J, Garrido, P, Campelo, RG, Aparisi, F, Diz, P, Aguiar, D, Garcia-Giron, C, Hidalgo, J, Aguado, C, Gonzalez, JG, Esteban, E, Gomez-Aldavari, L, Moran, T, Juan, O, Chara, LE, Marti, JL, Castro, RL, Ortega, AL, Moreno, EM, Coves, J, Pena, AMS, Bosch-Barrera, J, Gastaldo, AS, Nunez, NF, del Barco, E, Cobo, M, Isla, D, Majem, M, Navarro, F, Calvo, V
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
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:p4921
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4921
http://ddd.uab.cat/record/237596
Access Level:acceso abierto
Palabra clave:Osimertinib
Real-world data
EGFR-activating mutations
T790M EGFR mutation
Second line
Non-small cell lung cancer
Descripción
Sumario:BackgroundAURA study reported 61% objective response rate and progression-free survival of 9.6months 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.MethodsPost-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.Results70% 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 11.8months. 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 9.4months. 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.ConclusionThis 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.Trial registrationClinical trial registration number:NCT03790397.

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