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oai:repisalud.isciii.es:20.500.12105/182812024-02-19T15:26:23Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927col_20.500.12105_16964col_20.500.12105_16985col_20.500.12105_16988
Repisalud author Provencio, Mariano author Terrasa, Josefa author Garrido, Pilar author Campelo, Rosario García author Aparisi, Francisco author Diz, Pilar author Aguiar, David author García-Giron, Carlos author Hidalgo, Julia author Aguado, Carlos author González, Jorge García author Esteban, Emilio author Gómez-Aldavarí, Lorenzo author Moran, Teresa author Juan, Oscar author Chara, Luís Enrique author Marti, Juan L author Castro, Rafael López author Ortega, Ana Laura author Moreno, Elia Martínez author Coves, Juan author Sánchez Peña, Ana M author Bosch-Barrera, Joaquim author Gastaldo, Amparo Sánchez author Núñez, Natalia Fernández author Del Barco, Edel author Cobo, Manuel author Isla, Dolores author Majem, Margarita author Navarro, Fátima author Calvo, Virginia 2024-02-19T15:26:23Z 2024-02-19T15:26:23Z 2021-03-06 10.1186/s12885-021-07922-5 1471-2407 BMC cancer http://hdl.handle.net/10668/17320 33676426 http://hdl.handle.net/20.500.12105/18281 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 . eng EGFR-activating mutations Non-small cell lung cancer Osimertinib Real-world data Second line T790M EGFR mutation 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. research article