Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC

In ADAURA, adjuvant osimertinib significantly improved disease-free survival versus placebo in resected stage IB to IIIA EGFR-mutated NSCLC. We report in-depth analyses of three-year safety, tolerability, and health-related quality of life (HRQoL) from ADAURA. Patients were randomized 1:1 to osimert...

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Autores: John, Thomas|||0000-0003-3399-5342, Grohé, Christian, Goldman, Jonathan W., Shepherd, Frances A., De Marinis, Filippo, Kato, Terufumi, Wang, Qun, Su, Wu-Chou, Choi, Jin Hyuk, Sriuranpong, Virote, Melotti, Barbara, Fidler, Mary J., Chen, Jun, Albayaty, Muna, Stachowiak, Marta, Taggart, Sarah, Wu, Yi-Long|||0000-0002-3611-0258, Tsuboi, Masahiro, Herbst, Roy S.|||0000-0003-2535-5847, Majem Tarruella, Margarita|||0000-0002-9919-7485
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:303869
Acceso en línea:https://ddd.uab.cat/record/303869
https://dx.doi.org/urn:doi:10.1016/j.jtho.2023.05.015
Access Level:acceso abierto
Palabra clave:Adjuvant
EGFR
Non-small cell lung cancer
Osimertinib
Safety
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spelling Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLCUpdated Analysis From the Phase 3 ADAURA TrialJohn, Thomas|||0000-0003-3399-5342Grohé, ChristianGoldman, Jonathan W.Shepherd, Frances A.De Marinis, FilippoKato, TerufumiWang, QunSu, Wu-ChouChoi, Jin HyukSriuranpong, ViroteMelotti, BarbaraFidler, Mary J.Chen, JunAlbayaty, MunaStachowiak, MartaTaggart, SarahWu, Yi-Long|||0000-0002-3611-0258Tsuboi, MasahiroHerbst, Roy S.|||0000-0003-2535-5847Majem Tarruella, Margarita|||0000-0002-9919-7485AdjuvantEGFRNon-small cell lung cancerOsimertinibSafetyIn ADAURA, adjuvant osimertinib significantly improved disease-free survival versus placebo in resected stage IB to IIIA EGFR-mutated NSCLC. We report in-depth analyses of three-year safety, tolerability, and health-related quality of life (HRQoL) from ADAURA. Patients were randomized 1:1 to osimertinib 80 mg or placebo once daily for up to 3 years. Safety assessments were performed at baseline, week 2, week 4, week 12, and every 12 weeks until treatment completion or discontinuation, and 28 days after treatment was stopped. The SF-36 survey measured HRQoL at baseline, week 12, week 24, and every 24 weeks until recurrence, treatment completion or discontinuation. Data cutoff: April 11, 2022. Safety and HRQoL analysis sets: osimertinib, n = 337 and n = 339; placebo, n = 343 each. Median (range) total exposure duration was longer with osimertinib versus placebo: 35.8 (0-38) versus 25.1 (0-39) months. Most adverse events (AEs) were first reported within 12 months of starting treatment (osimertinib 97%, placebo 86%). AEs leading to dose reduction, interruption or discontinuation were reported in 12%, 27% and 13% respectively of patients with osimertinib; 1%, 13% and 3% with placebo. Stomatitis and diarrhea were the most common AEs leading to osimertinib dose reduction or interruption; interstitial lung disease was the most common leading to osimertinib discontinuation (per protocol). There were no differences in time to deterioration for SF-36 physical, mental component summaries between osimertinib and placebo. No new safety signals were reported and HRQoL was maintained with 3 years of adjuvant osimertinib treatment. Combined with significant efficacy benefit, these data further support adjuvant osimertinib in stage IB to IIIA EGFR-mutated NSCLC.Universitat Autònoma de Barcelona 22023-01-0120232023-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/303869https://dx.doi.org/urn:doi:10.1016/j.jtho.2023.05.015reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3038692026-06-06T12:50:31Z
dc.title.none.fl_str_mv Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
Updated Analysis From the Phase 3 ADAURA Trial
title Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
spellingShingle Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
John, Thomas|||0000-0003-3399-5342
Adjuvant
EGFR
Non-small cell lung cancer
Osimertinib
Safety
title_short Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
title_full Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
title_fullStr Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
title_full_unstemmed Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
title_sort Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC
dc.creator.none.fl_str_mv John, Thomas|||0000-0003-3399-5342
Grohé, Christian
Goldman, Jonathan W.
Shepherd, Frances A.
De Marinis, Filippo
Kato, Terufumi
Wang, Qun
Su, Wu-Chou
Choi, Jin Hyuk
Sriuranpong, Virote
Melotti, Barbara
Fidler, Mary J.
Chen, Jun
Albayaty, Muna
Stachowiak, Marta
Taggart, Sarah
Wu, Yi-Long|||0000-0002-3611-0258
Tsuboi, Masahiro
Herbst, Roy S.|||0000-0003-2535-5847
Majem Tarruella, Margarita|||0000-0002-9919-7485
author John, Thomas|||0000-0003-3399-5342
author_facet John, Thomas|||0000-0003-3399-5342
Grohé, Christian
Goldman, Jonathan W.
Shepherd, Frances A.
De Marinis, Filippo
Kato, Terufumi
Wang, Qun
Su, Wu-Chou
Choi, Jin Hyuk
Sriuranpong, Virote
Melotti, Barbara
Fidler, Mary J.
Chen, Jun
Albayaty, Muna
Stachowiak, Marta
Taggart, Sarah
Wu, Yi-Long|||0000-0002-3611-0258
Tsuboi, Masahiro
Herbst, Roy S.|||0000-0003-2535-5847
Majem Tarruella, Margarita|||0000-0002-9919-7485
author_role author
author2 Grohé, Christian
Goldman, Jonathan W.
Shepherd, Frances A.
De Marinis, Filippo
Kato, Terufumi
Wang, Qun
Su, Wu-Chou
Choi, Jin Hyuk
Sriuranpong, Virote
Melotti, Barbara
Fidler, Mary J.
Chen, Jun
Albayaty, Muna
Stachowiak, Marta
Taggart, Sarah
Wu, Yi-Long|||0000-0002-3611-0258
Tsuboi, Masahiro
Herbst, Roy S.|||0000-0003-2535-5847
Majem Tarruella, Margarita|||0000-0002-9919-7485
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Adjuvant
EGFR
Non-small cell lung cancer
Osimertinib
Safety
topic Adjuvant
EGFR
Non-small cell lung cancer
Osimertinib
Safety
description In ADAURA, adjuvant osimertinib significantly improved disease-free survival versus placebo in resected stage IB to IIIA EGFR-mutated NSCLC. We report in-depth analyses of three-year safety, tolerability, and health-related quality of life (HRQoL) from ADAURA. Patients were randomized 1:1 to osimertinib 80 mg or placebo once daily for up to 3 years. Safety assessments were performed at baseline, week 2, week 4, week 12, and every 12 weeks until treatment completion or discontinuation, and 28 days after treatment was stopped. The SF-36 survey measured HRQoL at baseline, week 12, week 24, and every 24 weeks until recurrence, treatment completion or discontinuation. Data cutoff: April 11, 2022. Safety and HRQoL analysis sets: osimertinib, n = 337 and n = 339; placebo, n = 343 each. Median (range) total exposure duration was longer with osimertinib versus placebo: 35.8 (0-38) versus 25.1 (0-39) months. Most adverse events (AEs) were first reported within 12 months of starting treatment (osimertinib 97%, placebo 86%). AEs leading to dose reduction, interruption or discontinuation were reported in 12%, 27% and 13% respectively of patients with osimertinib; 1%, 13% and 3% with placebo. Stomatitis and diarrhea were the most common AEs leading to osimertinib dose reduction or interruption; interstitial lung disease was the most common leading to osimertinib discontinuation (per protocol). There were no differences in time to deterioration for SF-36 physical, mental component summaries between osimertinib and placebo. No new safety signals were reported and HRQoL was maintained with 3 years of adjuvant osimertinib treatment. Combined with significant efficacy benefit, these data further support adjuvant osimertinib in stage IB to IIIA EGFR-mutated NSCLC.
publishDate 2023
dc.date.none.fl_str_mv 2
2023-01-01
2023
2023-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/303869
https://dx.doi.org/urn:doi:10.1016/j.jtho.2023.05.015
url https://ddd.uab.cat/record/303869
https://dx.doi.org/urn:doi:10.1016/j.jtho.2023.05.015
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
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dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
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