Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC

Lu S.; Kato T.; Dong X.; Ahn M.J.; Quang L.V.; Soparattanapaisarn N.; Inoue T.; Wang C.L.; Huang M.; Yang J.C.H.; Cobo M.; Özgüroǧlu M.; Casarini I.; Khiem D.V.; Sriuranpong V.; Cronemberger E.; Takahashi T.; Runglodvatana Y.; Chen M.; Huang X.; Grainger E.; Ghiorghiu D.; Van Der Gronde T.; Ramalingam S.S.

Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC

Issued Date

2024-08-15

Resource Type

Article

ISSN

00284793

eISSN

15334406

DOI

10.1056/NEJMoa2402614

Scopus ID

2-s2.0-85199448013

Pubmed ID

38828946

Journal Title

New England Journal of Medicine

Volume

391

Issue

7

Start Page

585

End Page

597

Rights Holder(s)

SCOPUS

Bibliographic Citation

New England Journal of Medicine Vol.391 No.7 (2024) , 585-597

Suggested Citation

Lu S., Kato T., Dong X., Ahn M.J., Quang L.V., Soparattanapaisarn N., Inoue T., Wang C.L., Huang M., Yang J.C.H., Cobo M., Özgüroǧlu M., Casarini I., Khiem D.V., Sriuranpong V., Cronemberger E., Takahashi T., Runglodvatana Y., Chen M., Huang X., Grainger E., Ghiorghiu D., Van Der Gronde T., Ramalingam S.S. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. New England Journal of Medicine Vol.391 No.7 (2024) , 585-597. 597. doi:10.1056/NEJMoa2402614 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/100702

Title

Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC

Corresponding Author(s)

Lu S.

Other Contributor(s)

Mahidol University

Abstract

Background Osimertinib is a recommended treatment for advanced non-small-cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation and as adjuvant treatment for resected EGFR-mutated NSCLC. EGFR tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III EGFR-mutated NSCLC. Methods In this phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with unresectable EGFR-mutated stage III NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression occurred (as assessed by blinded independent central review) or the regimen was discontinued. The primary end point was progression-free survival as assessed by blinded independent central review. Results A total of 216 patients who had undergone chemoradiotherapy were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant progression-free survival benefit as compared with placebo: the median progression-free survival was 39.1 months with osimertinib versus 5.6 months with placebo, with a hazard ratio for disease progression or death of 0.16 (95% confidence interval [CI], 0.10 to 0.24; P<0.001). The percentage of patients who were alive and progression free at 12 months was 74% (95% CI, 65 to 80) with osimertinib and 22% (95% CI, 13 to 32) with placebo. Interim overall survival data (maturity, 20%) showed 36-month overall survival among 84% of patients with osimertinib (95% CI, 75 to 89) and 74% with placebo (95% CI, 57 to 85), with a hazard ratio for death of 0.81 (95% CI, 0.42 to 1.56; P=0.53). The incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group; radiation pneumonitis (majority grade, 1 to 2) was reported in 48% and 38%, respectively. No new safety concerns emerged. Conclusions Treatment with osimertinib resulted in significantly longer progression-free survival than placebo in patients with unresectable stage III EGFR-mutated NSCLC.

Keyword(s)

Medicine

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/100702

Collections

Scopus 2024

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