Provencio, MarianoTerrasa, JosefaGarrido, PilarCampelo, Rosario GarciaAparisi, FranciscoDiz, PilarAguiar, DavidGarcia-Giron, CarlosHidalgo, JuliaAguado, CarlosGonzalez, Jorge GarciaEsteban, EmilioGomez-Aldavarí, LorenzoMoran, TeresaJuan, OscarChara, Luis EnriqueMarti, Juan LCastro, Rafael LopezOrtega, Ana LauraMoreno, Elia MartínezCoves, JuanSanchez Peña, Ana MBosch-Barrera, JoaquimGastaldo, Amparo SanchezNuñez, Natalia FernandezDel Barco, EdelCobo, ManuelIsla, DoloresMajem, MargaritaNavarro, FatimaCalvo, Virginia2023-02-092023-02-092021-02-17Provencio 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):230http://hdl.handle.net/10668/17320SiAURA 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 .enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/EGFR-activating mutationsNon-small cell lung cancerOsimertinibReal-world dataSecond lineT790M EGFR mutationAcrylamidesAdultAgedAged, 80 and overAniline CompoundsCarcinoma, non-small-cell lungErbB receptorsFemaleFollow-up StudiesHumansLungLung neoplasmsMaleMiddle agedMutationNeoplasm stagingProgression-free survivalProtein kinase inhibitorsRetrospective studiesSpainresearch article33676426open accessAcrilamidasCarcinoma de pulmón de células no pequeñasCompuestos de anilinaEstadificación de NeoplasiasInhibidores de proteínas quinasasNeoplasias pulmonaresPulmónReceptores ErbBSupervivencia sin progresión10.1186/s12885-021-07922-51471-2407PMC7937205https://doi.org/10.1186/s12885-021-07922-5https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937205/pdf