Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain

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-i...

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Detalles Bibliográficos
Autores: Provencio Pulla, Mariano|||0000-0001-6315-7919, Terrasa, Josefa, Garrido, Pilar|||0000-0002-5899-6125, Campelo, Rosario García, Aparisi, Francisco, Diz Taín, Pilar|||0000-0003-4284-3965, Aguiar, David, García-Giron, Carlos, Hidalgo, Julia, Aguado, Carlos|||0000-0002-5624-8035, González, Jorge García, Esteban, Emilio, Gómez-Aldavarí, Lorenzo, Morán, Teresa, Juan, Óscar|||0000-0002-7772-9030, Chara, Luís Enrique, Marti, Juan L., Castro, Rafael López, Ortega Granados, Ana Laura|||0000-0002-5727-3371, Moreno, Elia Martínez, Coves, Juan, Sánchez Peña, Ana M., Bosch-Barrera, J.|||0000-0002-0893-7821, Gastaldo, Amparo Sánchez, Fernández Núñez, Natalia, Del Barco Morillo, Edel|||0000-0001-6443-0585, Cobo, Manuel|||0000-0003-3402-1144, Isla, Dolores|||0000-0002-2483-198X, Majem Tarruella, Margarita|||0000-0002-9919-7485, Navarro, Fátima, Calvo, Virginia|||0000-0002-3503-4847
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:237596
Acceso en línea:https://ddd.uab.cat/record/237596
https://dx.doi.org/urn:doi:10.1186/s12885-021-07922-5
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: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.

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