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Title: Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC.
Austin Authors: Wu, Yi-Long;John, Thomas ;Grohe, Christian;Majem, Margarita;Goldman, Jonathan W;Kim, Sang-We;Kato, Terufumi;Laktionov, Konstantin;Vu, Huu Vinh;Wang, Zhijie;Lu, Shun;Lee, Kye Young;Akewanlop, Charuwan;Yu, Chong-Jen;de Marinis, Filippo;Bonanno, Laura;Domine, Manuel;Shepherd, Frances A;Zeng, Lingmin;Atasoy, Ajlan;Herbst, Roy S;Tsuboi, Masahiro
Affiliation: Late Oncology Research & Development, AstraZeneca, Cambridge, UK
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.
Department of Medical Oncology, Austin Health, Melbourne, Australia
Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin, Germany
Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
David Geffen School of Medicine at University of California, Los Angeles, California, US
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan
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
Department of Thoracic Surgery, Choray Hospital, Ho Chi Minh City, Vietnam
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, China
Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China
Precision Medicine Lung Cancer Center, Konkuk University Medical Center, Seoul, South Korea
Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand
Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch and National Taiwan University College of Medicine, Taipei, Taiwan
Thoracic Oncology Division, European Institute of Oncology (IEO), IRCCS, Milan, Italy
Medical Oncology 2, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy
Oncology department, Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Madrid, Spain
Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada
Late Oncology Statistics, AstraZeneca, Gaithersburg, Maryland, US
Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut, US
Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan
Issue Date: 2022
Date: 2021-11-02
Publication information: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2022; 17(3): 423-433
Abstract: Adjuvant chemotherapy is recommended in patients with resected stage IIꟷIIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase III, ADAURA study (NCT02511106), osimertinib demonstrated a highly statistically significant improvement in disease-free survival (DFS) in patients with resected stage IBꟷIIIA EGFRm NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA. Patients with resected stage IBꟷIIIA 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 (IBꟷIIIA), with/without adjuvant chemotherapy, was a prespecified analysis. Exploratory analyses included: adjuvant chemotherapy use by patient age, disease stage and geographical location; DFS by adjuvant chemotherapy use and disease stage. Overall, 410/682 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 <70 years (338/509; 66%) versus ≥70 years (72/173; 42%); with stage II-IIIA disease (352/466; 76%) versus stage IB (57/216; 26%); enrolled in Asia (268/414; 65%) versus outside of Asia (142/268; 53%). A DFS benefit favoring osimertinib versus placebo was observed in patients with (DFS HR = 0.16, 95% CI: 0.10ꟷ0.26) and without adjuvant chemotherapy (HR = 0.23, 95% CI: 0.13ꟷ0.40), regardless of disease stage. These findings support adjuvant osimertinib as an effective treatment for patients with stage IB-IIIA EGFRm NSCLC after resection, with or without prior adjuvant chemotherapy.
DOI: 10.1016/j.jtho.2021.10.014
Journal: Journal of Thoracic Oncology
PubMed URL: 34740861
Type: Journal Article
Subjects: Adjuvant chemotherapy
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