Provencio, MarianoTerrasa, JosefaGarrido, PilarCampelo, Rosario GarcíaAparisi, FranciscoDiz, PilarAguiar, DavidGarcía-Giron, CarlosHidalgo, JuliaAguado, CarlosGonzález, Jorge GarcíaEsteban, EmilioGómez-Aldavarí, LorenzoMoran, TeresaJuan, OscarChara, Luís EnriqueMarti, Juan LCastro, Rafael LópezOrtega, Ana LauraMoreno, Elia MartínezCoves, JuanSánchez Peña, Ana MBosch-Barrera, JoaquimGastaldo, Amparo SánchezNúñez, Natalia FernándezDel Barco, EdelCobo, ManuelIsla, DoloresMajem, MargaritaNavarro, FátimaCalvo, Virginia2024-02-192024-02-192021-03-06http://hdl.handle.net/10668/17320http://hdl.handle.net/20.500.12105/18281AURA 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 .engVoRhttp://creativecommons.org/licenses/by/4.0/EGFR-activating mutationsNon-small cell lung cancerOsimertinibReal-world dataSecond lineT790M EGFR mutationAcrylamidesAdultAgedAttribution 4.0 International3367642621123010.1186/s12885-021-07922-51471-2407BMC canceropen access