Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC |
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| Affiliation: | 1. Guangdong Lung Cancer Institute, Guangdong Provincial People''s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People’s Republic of China;2. Department of Medical Oncology, Austin Health, Melbourne, Australia;3. Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin, Germany;4. Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain;5. David Geffen School of Medicine at University of California, Los Angeles, California;6. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea;7. Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan;8. Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russia;9. Department of Thoracic Surgery, Choray Hospital, Ho Chi Minh City, Vietnam;10. State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People’s Republic of China;11. Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China;12. Precision Medicine Lung Cancer Center, Konkuk University Medical Center, Seoul, South Korea;13. Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand;14. Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch and National Taiwan University College of Medicine, Taipei, Taiwan;15. Thoracic Oncology Division, European Institute of Oncology (IEO), IRCCS, Milan, Italy;p. Medical Oncology 2, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy;q. Oncology Department, Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Madrid, Spain;r. Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada;s. Late Oncology Statistics, AstraZeneca, Gaithersburg, Maryland;t. Late Oncology Research & Development, AstraZeneca, Cambridge, United Kingdom;u. Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut;v. Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan |
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| Abstract: | IntroductionAdjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a clinically meaningful improvement in disease-free survival (DFS) in patients with resected stages IB to IIIA EGFR-mutated (EGFRm) NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA.MethodsPatients with resected stages IB to IIIA EGFRm NSCLC were randomized 1:1 to receive osimertinib or placebo for 3 years. Adjuvant chemotherapy before randomization was not mandatory, per physician and patient choice. DFS in the overall population (IB–IIIA), with and without adjuvant chemotherapy, was a prespecified analysis. Exploratory analyses included the following: adjuvant chemotherapy use by patient age, disease stage, and geographic location; DFS by adjuvant chemotherapy use and disease stage.ResultsOverall, 410 of 682 patients (60%) received adjuvant chemotherapy (osimertinib, n = 203; placebo, n = 207) for a median duration of 4.0 cycles. Adjuvant chemotherapy use was more frequent in patients: aged less than 70 years (338 of 509; 66%) versus more than or equal to 70 years (72 of 173; 42%); with stages II to IIIA (352 of 466; 76%) versus stage IB (57 of 216; 26%); and enrolled in Asia (268 of 414; 65%) versus outside of Asia (142 of 268; 53%). A DFS benefit favoring osimertinib versus placebo was observed in patients with (DFS hazard ratio = 0.16, 95% confidence interval: 0.10–0.26) and without adjuvant chemotherapy (hazard ratio = 0.23, 95% confidence interval: 0.13–0.40), regardless of disease stage.ConclusionsThese findings support adjuvant osimertinib as an effective treatment for patients with stages IB to IIIA EGFRm NSCLC after resection, with or without previous adjuvant chemotherapy. |
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| Keywords: | Adjuvant chemotherapy EGFR EGFR-TKI NSCLC Osimertinib |
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