%0 Journal Article
%A Provencio, Mariano
%A Terrasa, Josefa
%A Garrido, Pilar
%A Campelo, Rosario Garcia
%A Aparisi, Francisco
%A Diz, Pilar
%A Aguiar, David
%A Garcia-Giron, Carlos
%A Hidalgo, Julia
%A Aguado, Carlos
%A Gonzalez, Jorge Garcia
%A Esteban, Emilio
%A Gomez-Aldavarí, Lorenzo
%A Moran, Teresa
%A Juan, Oscar
%A Chara, Luis Enrique
%A Marti, Juan L
%A Castro, Rafael Lopez
%A Ortega, Ana Laura
%A Moreno, Elia Martínez
%A Coves, Juan
%A Sanchez Peña, Ana M
%A Bosch-Barrera, Joaquim
%A Gastaldo, Amparo Sanchez
%A Nuñez, Natalia Fernandez
%A Del Barco, Edel
%A Cobo, Manuel
%A Isla, Dolores
%A Majem, Margarita
%A Navarro, Fatima
%A Calvo, Virginia
%T 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.
%D 2021
%U http://hdl.handle.net/10668/17320
%X 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. 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 .
%K EGFR-activating mutations
%K Non-small cell lung cancer
%K Osimertinib
%K Real-world data
%K Second line
%K T790M EGFR mutation
%~