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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

BACKGROUND: 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. METHODS: Post...

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Detalles Bibliográficos
Autores principales: 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, Ortega, Ana Laura, 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937205/
https://www.ncbi.nlm.nih.gov/pubmed/33676426
http://dx.doi.org/10.1186/s12885-021-07922-5
Descripción
Sumario:BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: Clinical trial registration number: NCT03790397.