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.

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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Authors: 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
Format: article
Publication Date:2021
Country:España
Institution:Instituto de Salud Carlos III (ISCIII)
Repository:Repisalud
Language:English
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/18281
Online Access:http://hdl.handle.net/20.500.12105/18281
Access Level:Open access
Keyword:EGFR-activating mutations
Non-small cell lung cancer
Osimertinib
Real-world data
Second line
T790M EGFR mutation
Acrylamides
Adult
Aged
Description
Summary: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 .

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