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

Autor: Provencio, Mariano, Terrasa, Josefa, Garrido, Pilar, Campelo, Rosario García, Aparisi, Francisco, Diz, Pilar, Aguiar, David, García-Giron, Carlos, Hidalgo, Julia, Aguado, Carlos, González, Jorge García, Esteban, Emilio, Gómez-Aldavarí, Lorenzo, Moran, Teresa, Juan, Oscar, Chara, Luís Enrique, Marti, Juan L., Castro, Rafael López, Ana Laura Ortega Granados, Moreno, Elia Martínez, Coves, Juan, Sánchez Peña, Ana M., Bosch-Barrera, Joaquim, Gastaldo, Amparo Sánchez, Núñez, Natalia Fernández, Del Barco, Edel, Cobo, Manuel, Isla, Dolores, Majem, Margarita, Navarro, Fátima, Calvo, Virginia
Rok vydání: 2021
Předmět:
Zdroj: BMC Cancer
r-FISABIO. Repositorio Institucional de Producción Científica
instname
r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol
BMC CANCER
r-FIHGUV. Repositorio Institucional de Producción Científica de la Fundación de Investigación del Hospital General de Valencia
Banco de España
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
BASE-Bielefeld Academic Search Engine
r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
ISSN: 1471-2407
Popis: 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.
Databáze: OpenAIRE
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