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

BackgroundAURA study reported 61% objective response rate and progression-free survival of 9.6months 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.MethodsPost-autho...

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Autores: 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 de Juan, Virginia
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10256/28255
Acceso en línea:http://hdl.handle.net/10256/28255
Access Level:acceso abierto
Palabra clave:Osimertinib
Real-world data
EGFR-activating mutations
T790M EGFR mutation
Second line
Non-small cell lung cancer
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network_name_str España
repository_id_str
spelling 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 GroupProvencio, 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 de Juan, VirginiaOsimertinibReal-world dataEGFR-activating mutationsT790M EGFR mutationSecond lineNon-small cell lung cancerBackgroundAURA study reported 61% objective response rate and progression-free survival of 9.6months 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.MethodsPost-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. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.Results70% 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 11.8months. 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 9.4months. 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.ConclusionThis 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.Trial registrationClinical trial registration number:NCT03790397The study was coordinated and monitored by the Spanish Lung Cancer Group (SLCG) and financed by AstraZeneca following the specifications in the protocol. This funding included the cost of submitting the study for approval to an accredited Independent Ethics Committee (IEC); submission for classification to the Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS); database design, maintenance and management; monitoring activities; statistical analysis and corresponding statistical reportBmc2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionpeer reviewedapplication/pdfhttp://hdl.handle.net/10256/28255Bmc Cancer, 2021, vol. 21, núm. 1, p. 230-230Articles publicats (IDIBGI)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)Inglésinfo:eu-repo/semantics/altIdentifier/doi/10.1186/s12885-021-07922-5info:eu-repo/semantics/altIdentifier/issn/1471-2407info:eu-repo/semantics/altIdentifier/eissn/1471-2407Attribution 4.0 International (CC BY 4.0)http://creativecommons.org/licenses/by/4.0/deed.cainfo:eu-repo/semantics/openAccessoai:recercat.cat:10256/282552026-05-29T05:05:01Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Provencio, Mariano
Osimertinib
Real-world data
EGFR-activating mutations
T790M EGFR mutation
Second line
Non-small cell lung cancer
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv 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 de Juan, Virginia
author Provencio, Mariano
author_facet 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 de Juan, Virginia
author_role author
author2 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 de Juan, Virginia
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Osimertinib
Real-world data
EGFR-activating mutations
T790M EGFR mutation
Second line
Non-small cell lung cancer
topic Osimertinib
Real-world data
EGFR-activating mutations
T790M EGFR mutation
Second line
Non-small cell lung cancer
description BackgroundAURA study reported 61% objective response rate and progression-free survival of 9.6months 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.MethodsPost-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. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.Results70% 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 11.8months. 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 9.4months. 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.ConclusionThis 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.Trial registrationClinical trial registration number:NCT03790397
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
peer reviewed
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10256/28255
url http://hdl.handle.net/10256/28255
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1186/s12885-021-07922-5
info:eu-repo/semantics/altIdentifier/issn/1471-2407
info:eu-repo/semantics/altIdentifier/eissn/1471-2407
dc.rights.none.fl_str_mv Attribution 4.0 International (CC BY 4.0)
http://creativecommons.org/licenses/by/4.0/deed.ca
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International (CC BY 4.0)
http://creativecommons.org/licenses/by/4.0/deed.ca
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Bmc
publisher.none.fl_str_mv Bmc
dc.source.none.fl_str_mv Bmc Cancer, 2021, vol. 21, núm. 1, p. 230-230
Articles publicats (IDIBGI)
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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