RT Journal Article
T1 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.
A1 Provencio, Mariano
A1 Terrasa, Josefa
A1 Garrido, Pilar
A1 Campelo, Rosario Garcia
A1 Aparisi, Francisco
A1 Diz, Pilar
A1 Aguiar, David
A1 Garcia-Giron, Carlos
A1 Hidalgo, Julia
A1 Aguado, Carlos
A1 Gonzalez, Jorge Garcia
A1 Esteban, Emilio
A1 Gomez-Aldavarí, Lorenzo
A1 Moran, Teresa
A1 Juan, Oscar
A1 Chara, Luis Enrique
A1 Marti, Juan L
A1 Castro, Rafael Lopez
A1 Ortega, Ana Laura
A1 Moreno, Elia Martínez
A1 Coves, Juan
A1 Sanchez Peña, Ana M
A1 Bosch-Barrera, Joaquim
A1 Gastaldo, Amparo Sanchez
A1 Nuñez, Natalia Fernandez
A1 Del Barco, Edel
A1 Cobo, Manuel
A1 Isla, Dolores
A1 Majem, Margarita
A1 Navarro, Fatima
A1 Calvo, Virginia
K1 EGFR-activating mutations
K1 Non-small cell lung cancer
K1 Osimertinib
K1 Real-world data
K1 Second line
K1 T790M EGFR mutation
AB 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 .
PB Springer Nature
YR 2021
FD 2021-02-17
LK http://hdl.handle.net/10668/17320
UL http://hdl.handle.net/10668/17320
LA en
NO Provencio M, Terrasa J, Garrido P, Campelo RG, Aparisi F, Diz P, et al. 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. BMC Cancer. 2021 Mar 6;21(1):230
NO Si
DS RISalud
RD Apr 19, 2025