Overall Survival with Osimertinib in Resected

Humans Antineoplastic Combined Chemotherapy Protocols / therapeutic use Carcinoma, Non-Small-Cell Lung / drug therapy COVID-19 / etiology ErbB Receptors / genetics Lung Neoplasms / drug therapy Mutation Neoplasm Recurrence, Local / drug therapy Survival Analysis

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
13 Jul 2023

Historique:

medline: 14 7 2023

pubmed: 5 6 2023

entrez: 5 6 2023

Statut: ppublish

Résumé

Among patients with resected, epidermal growth factor receptor ( In this phase 3, double-blind trial, we randomly assigned eligible patients in a 1:1 ratio to receive osimertinib (80 mg once daily) or placebo until disease recurrence was observed, the trial regimen was completed (3 years), or a discontinuation criterion was met. The primary end point was investigator-assessed disease-free survival among patients with stage II to IIIA disease. Secondary end points included disease-free survival among patients with stage IB to IIIA disease, overall survival, and safety. Of 682 patients who underwent randomization, 339 received osimertinib and 343 received placebo. Among patients with stage II to IIIA disease, the 5-year overall survival was 85% in the osimertinib group and 73% in the placebo group (overall hazard ratio for death, 0.49; 95.03% confidence interval [CI], 0.33 to 0.73; P<0.001). In the overall population (patients with stage IB to IIIA disease), the 5-year overall survival was 88% in the osimertinib group and 78% in the placebo group (overall hazard ratio for death, 0.49; 95.03% CI, 0.34 to 0.70; P<0.001). One new serious adverse event, pneumonia related to coronavirus disease 2019, was reported after the previously published data-cutoff date (the event was not considered by the investigator to be related to the trial regimen, and the patient fully recovered). Adjuvant osimertinib had a safety profile consistent with that in the primary analysis. Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected,

Sections du résumé

BACKGROUND BACKGROUND

Among patients with resected, epidermal growth factor receptor (

METHODS METHODS

In this phase 3, double-blind trial, we randomly assigned eligible patients in a 1:1 ratio to receive osimertinib (80 mg once daily) or placebo until disease recurrence was observed, the trial regimen was completed (3 years), or a discontinuation criterion was met. The primary end point was investigator-assessed disease-free survival among patients with stage II to IIIA disease. Secondary end points included disease-free survival among patients with stage IB to IIIA disease, overall survival, and safety.

RESULTS RESULTS

Of 682 patients who underwent randomization, 339 received osimertinib and 343 received placebo. Among patients with stage II to IIIA disease, the 5-year overall survival was 85% in the osimertinib group and 73% in the placebo group (overall hazard ratio for death, 0.49; 95.03% confidence interval [CI], 0.33 to 0.73; P<0.001). In the overall population (patients with stage IB to IIIA disease), the 5-year overall survival was 88% in the osimertinib group and 78% in the placebo group (overall hazard ratio for death, 0.49; 95.03% CI, 0.34 to 0.70; P<0.001). One new serious adverse event, pneumonia related to coronavirus disease 2019, was reported after the previously published data-cutoff date (the event was not considered by the investigator to be related to the trial regimen, and the patient fully recovered). Adjuvant osimertinib had a safety profile consistent with that in the primary analysis.

CONCLUSIONS CONCLUSIONS

Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected,

Identifiants

DOI: 10.1056/NEJMoa2304594 PMID: 37272535

pubmed: 37272535

doi: 10.1056/NEJMoa2304594

doi:

Substances chimiques

EGFR protein, human EC 2.7.10.1

ErbB Receptors EC 2.7.10.1

osimertinib 3C06JJ0Z2O

Banques de données

ClinicalTrials.gov

['NCT02511106']

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

137-147

Investigateurs

Nimit Singhal (N)

Chee Lee (C)

Vinod Ganju (V)

Rachel Dear (R)

John Grygiel (J)

Lorraine Chantrill (L)

Venessa Chin (V)

Christos Karapetis (C)

Kenneth O'Byrne (K)

Thomas John (T)

Sagun Parakh (S)

Michael Boyer (M)

Renaud Poncin (R)

Lore Decoster (L)

Thierry Berghmans (T)

Thierry Pieters (T)

Sofie Derijcke (S)

Veerle Surmont (V)

Petra Boegner (P)

Zita Lea Mekinda Ngono (ZL)

Jose Miziara (J)

Nils Skare (N)

Leandro Brust (L)

Hakaru Tadokoro (H)

Sabina Aleixo (S)

Giuliano Borges (G)

Clarissa Mathias (C)

Carlos Henrique Barrios (CH)

Ormando Campos (O)

Yeni Neron (Y)

José Altino (J)

Carolina Haddad (C)

Aknar Calabrich (A)

Luiz Henrique Araujo (LH)

Mauro Zukin (M)

Clarissa Baldotto (C)

Claudia Sette (C)

Ellias Lima (E)

Monica Padoan (M)

Sandeep Sehdev (S)

Mahmoud Abdelsalam (M)

Frances Shepherd (F)

Wenzhao Zhong (W)

Min Tao (M)

Xiaoqing Liu (X)

Dong Wang (D)

Houjie Liang (H)

Jian Fang (J)

Jianjin Huang (J)

Buhai Wang (B)

Peiguo Cao (P)

Li Zhang (L)

Wei Li (W)

Qun Wang (Q)

Qing Xu (Q)

Man Li (M)

Yang Zhang (Y)

Xuenong Ouyang (X)

Yanrong Hao (Y)

Ying Cheng (Y)

Jian Hu (J)

Yongqian Shu (Y)

Xiaofei Li (X)

Yu Yao (Y)

Jianxing He (J)

Jie Wang (J)

Li Shan (L)

Shanqing Li (S)

Weimin Mao (W)

Changli Wang (C)

Gaofeng Li (G)

Haitao Ma (H)

Shun Lu (S)

Yunpeng Liu (Y)

Zhu Zhang (Z)

Xun Zhang (X)

Hongbing Duan (H)

Jun Chen (J)

Qiming Wang (Q)

Songlei Ou (S)

Yue Yang (Y)

Guofang Zhao (G)

Marie Wislez (M)

Jacques Cadranel (J)

Michael Duruisseaux (M)

Marylise Ginoux (M)

Nicolas Girard (N)

Maurice Perol (M)

Alain Vergnenegre (A)

Alexis Cortot (A)

Christian Grohe (C)

Dirk Koschel (D)

Joachim von Pawel (J)

Niels Reinmuth (N)

Martin Wolf (M)

Markus Wohlleber (M)

Martin Kohlhäufl (M)

Martin Reck (M)

Rolf Mahlberg (R)

Wolfgang Schütte (W)

Eva Lotte Buchmeier (EL)

Walburga Engel-Riedel (W)

Achim Rittmeyer (A)

Sabine Bohnet (S)

Thomas Wehler (T)

Sven Henschke (S)

Jens Panse (J)

Konrad Kokowski (K)

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Bernd Schmidt (B)

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