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Osimertinib in Resected EGFR -Mutated Non–Small-Cell Lung Cancer
Open accessAbstract
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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Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
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Self-citationOsimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer
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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
- Publisher
- Massachusetts Medical Society
- 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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- 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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