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Osimertinib in Resected EGFR -Mutated Non–Small-Cell Lung Cancer

Open access
Wu, Yi-Long, Tsuboi, Masahiro, He, Jie, John, Thomas, Grohe, Christian, Majem, Margarita, Goldman, Jonathan W., Laktionov, Konstantin, Kim, Sang-We, Kato, Terufumi, Vu, Huu-Vinh, Lu, Shun, Lee, Kye-Young, Akewanlop, Charuwan, Yu, Chong-Jen, de Marinis, Filippo, Bonanno, Laura, Domine, Manuel, Shepherd, Frances A., Zeng, Lingmin, Hodge, Rachel, Atasoy, Ajlan, Rukazenkov, Yuri, Herbst, Roy S.·2020·New England Journal of Medicine

Abstract

BACKGROUND: ) mutation-positive advanced non-small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown. METHODS: mutation-positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease (according to investigator assessment). The secondary end points included disease-free survival in the overall population of patients with stage IB to IIIA disease, overall survival, and safety. RESULTS: A total of 682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group). At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001). In the overall population, 89% of the patients in the osimertinib group (95% CI, 85 to 92) and 52% of those in the placebo group (95% CI, 46 to 58) were alive and disease-free at 24 months (overall hazard ratio for disease recurrence or death, 0.20; 99.12% CI, 0.14 to 0.30; P<0.001). At 24 months, 98% of the patients in the osimertinib group (95% CI, 95 to 99) and 85% of those in the placebo group (95% CI, 80 to 89) were alive and did not have central nervous system disease (overall hazard ratio for disease recurrence or death, 0.18; 95% CI, 0.10 to 0.33). Overall survival data were immature; 29 patients died (9 in the osimertinib group and 20 in the placebo group). No new safety concerns were noted. CONCLUSIONS: mutation-positive NSCLC, disease-free survival was significantly longer among those who received osimertinib than among those who received placebo. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.).

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Metadata

Authors
Wu, Y.-L., Tsuboi, M., He, J., John, T., Grohe, C., Majem, M., Goldman, J. W., Laktionov, K., Kim, S.-W., Kato, T., Vu, H.-V., Lu, S., Lee, K.-Y., Akewanlop, C., Yu, C.-J., de Marinis, F., Bonanno, L., Domine, M., Shepherd, F. A., Zeng, L., Hodge, R., Atasoy, A., Rukazenkov, Y., & Herbst, R. S.
Venue
New England Journal of Medicine
Published
2020-10-29
Volume
383
Issue
18
Pages
1711-1723
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3087210493
Cited by
1,798
References
12
FWCI
130.28
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Osimertinib in Resected EGFR -Mutated Non–Small-Cell Lung Cancer. https://app.cochat.ai/papers/10.1056/nejmoa2027071
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Wu, Y.-L., Tsuboi, M., He, J., John, T., Grohe, C., Majem, M., Goldman, J. W., Laktionov, K., Kim, S.-W., Kato, T., Vu, H.-V., Lu, S., Lee, K.-Y., Akewanlop, C., Yu, C.-J., de Marinis, F., Bonanno, L., Domine, M., Shepherd, F. A., . . . Herbst, R. S. (2020). Osimertinib in Resected EGFR -Mutated Non–Small-Cell Lung Cancer. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2027071

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.