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Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small Cell Lung Cancer

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机构： [1]Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University, China State Key Laboratory of Respiratory Disease & National Clinical Research Centre for Respiratory Disease, Guangzhou, China. [2]Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan. [3]Department of Thoracic Surgery, University of Zurich, Thoracic Surgery, Clinic Bethanien, Zurich, Switzerland. [4]State Key Laboratory of Molecular Oncology, Beijing Key Laboratory of Carcinogenesis and Translational Research, The First Department of Thoracic Surgery, Peking University Cancer Hospital & Institute, Beijing, China. [5]Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria. [6]Department of Respiratory and Critical Care Medicine, Klinik Floridsdorf, Vienna Healthcare Group, Vienna, Austria. [7]Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. [8]Division of Pulmonary Medicine, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea. [9]Division of Pulmonary Medicine, Department of Internal Medicine, Shuang-Ho Hospital, Taipei Medical University, Taipei, Taiwan. [10]Vietnam National Lung Hospital, Faculty of Medicine, UMP, VNU, Hanoi, Vietnam. [11]Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. [12]Department of Thoracic Surgery, West China Hospital of Sichuan University, Chengdu, China. [13]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China. [14]Department of Medical Oncology, Hanoi Oncology Hospital, Hanoi, Vietnam. [15]Department of Thoracic Oncology, Kanagawa Cancer Canter, Yokohama, Japan. [16]Department of Thoracic Surgery, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, China. [17]Orlandi Oncologia, Santiago, Chile. [18]Department of Internal Medicine, Pusan National University, School of Medicine, and Yangsan Hospital, Yangsan, Republic of Korea. [19]Clinical Oncology Department, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil. [20]Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, United Kingdom. [21]Department of Medical Oncology, Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, United Kingdom. [22]Department of Medical Oncology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital, Barcelona, Spain. [23]Department of Medicine, University of California, San Francisco, CA. [24]Helen Diller Comprehensive Cancer Center, University of California, San Francisco, CA. [25]Department of Diagnostic Pathology, National Cancer Center, Tokyo, Japan. [26]Department of Pathology, Yale School of Medicine, New Haven, CT. [27]Late-stage Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom. [28]Biometrics, Late-stage Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom. [29]Late-stage Development, Oncology R&D, AstraZeneca, Gaithersburg, MD. [30]Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY. [31]Department of Medicine, Weill Cornell Medical College, New York, NY.

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Adjuvant osimertinib is the standard of care for patients with resected epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Neoadjuvant treatment could improve surgical and long-term outcomes.In this randomized, controlled, phase III study, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC were randomly assigned (1:1:1) to receive neoadjuvant osimertinib (80 mg orally once daily for ≥9 weeks) plus platinum-based chemotherapy (once every 3 weeks for three cycles), osimertinib monotherapy (for ≥9 weeks), or placebo plus platinum-based chemotherapy (control), followed by surgical resection. Adjuvant osimertinib was offered to eligible patients after completion of surgery. The primary end point was major pathologic response (MPR) by blinded central pathology review. Event-free survival (EFS) was a secondary end point.Overall, 358 patients were randomly assigned to receive osimertinib plus chemotherapy (121 patients), osimertinib monotherapy (117 patients), or placebo plus chemotherapy (120 patients). Osimertinib plus chemotherapy (MPR rate 26%) and osimertinib monotherapy (25%) demonstrated statistically significant improvement in the MPR rate versus placebo plus chemotherapy (2%), with corresponding odds ratios of 19.82 (95.002% CI, 4.60 to 85.33; P < .0001) and 19.28 (99.9% CI, 1.71 to 217.39; P < .0001), respectively. With 15% data maturity, the EFS rates at 12 months were 93%, 95%, and 83% with osimertinib plus chemotherapy, osimertinib monotherapy, and placebo plus chemotherapy, respectively. In the neoadjuvant period, grade ≥3 adverse events of any cause occurred in 36%, 13%, and 33% of patients with osimertinib plus chemotherapy, osimertinib monotherapy, and placebo plus chemotherapy, respectively. No new safety concerns were identified.Neoadjuvant osimertinib with or without chemotherapy demonstrated statistically significant improvement in the MPR rate over chemotherapy alone in patients with resectable, EGFR-mutated, stage II-IIIB NSCLC.

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大类 | 1 区

医学

小类 | 1 区肿瘤学

最新[2025]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

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出版当年[2024]版：

Q1 ONCOLOGY

最新[2024]版：

Q1 ONCOLOGY

影响因子： 43.4 最新[2024版] 38.2 最新五年平均 43.4 出版当年[2024版] 0 出版当年五年平均 43.4 出版前一年[2024版]

第一作者：

第一作者机构： [1]Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University, China State Key Laboratory of Respiratory Disease & National Clinical Research Centre for Respiratory Disease, Guangzhou, China.

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通讯作者：

通讯机构： [30]Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY. [31]Department of Medicine, Weill Cornell Medical College, New York, NY.

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