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

Original ArticleFree PreviewList of authors.

  • Yi-Long Wu, M.D.,
  • Masahiro Tsuboi, M.D.,
  • Jie He, M.D.,
  • Thomas John, Ph.D.,
  • Christian Grohe, M.D.,
  • Margarita Majem, M.D.,
  • Jonathan W. Goldman, M.D.,
  • Konstantin Laktionov, Ph.D.,
  • Sang-We Kim, M.D., Ph.D.,
  • Terufumi Kato, M.D.,
  • Huu-Vinh Vu, M.D., Ph.D.,
  • Shun Lu, M.D.,
  • Kye-Young Lee, M.D., Ph.D.,
  • Charuwan Akewanlop, M.D.,
  • Chong-Jen Yu, M.D., Ph.D.,
  • Filippo de Marinis, M.D.,
  • Laura Bonanno, M.D.,
  • Manuel Domine, M.D., Ph.D.,
  • Frances A. Shepherd, M.D.,
  • Lingmin Zeng, Ph.D.,
  • Rachel Hodge, M.Sc.,
  • Ajlan Atasoy, M.D.,
  • Yuri Rukazenkov, M.D., Ph.D.,
  • and Roy S. Herbst, M.D., Ph.D.
  • for the ADAURA Investigators*

Abstract

Background

Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor (EGFR) mutation–positive advanced non–small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown.

Methods

In this double-blind, phase 3 trial, we randomly assigned patients with completely resected EGFR 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

Conclusions

In patients with stage IB to IIIA EGFR 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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Funding and Disclosures

Supported by AstraZeneca.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Drs. Wu and Tsuboi contributed equally to this article.

This article was published on September 19, 2020, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank all the patients and their families; all the trial site coordinators; Dakshayini Kulkarni, Ph.D., and Gianluca Laus, M.D., of the AstraZeneca ADAURA trial team for their contributions to the data analysis and study monitoring or oversight, respectively; the ADAURA independent data monitoring committee; and Natasha Learmond, B.Sc., of iMed Comms (an Ashfield Company, part of UDG Healthcare) for medical-writing support.

Author Affiliations

From the Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center–National Clinical Research Center for Cancer–Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) — all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) — both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) — both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) — both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).

Address reprint requests to Dr. Herbst at the Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, 333 Cedar St., P.O. Box 208028, New Haven, CT 06520, or at [email protected]; or to Dr. Wu at the Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, 510080, China, or at [email protected]; or to Dr. Tsuboi at the National Cancer Center Hospital East, 6 Chome-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan, or at [email protected].

*A complete list of the ADAURA investigators is provided in the Supplementary Appendix, available at NEJM.org.

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