Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study

BMC Cancer

Zhiping Yang¹  Li Yang²  Chuangzhou Rao³  Zhanchun Zhang⁴  Jianfang Wang⁵  Changlin Zou⁶  Jiafeng Liang⁷  Lucheng ZHU⁷  M. A. Shenglin⁸  Bing Xia⁹ 

[1] Department of Oncology, Affiliated Hospital of Jiaxing University, The First Hospital of Jiaxing, 314000, Jiaxing, People’s Republic of China;Department of Pulmonary & Critical Care Medicine, Shulan (Hangzhou) Hospital, Affiliated to Zhejiang Shuren University Shulan International Medical college, 310022, Hangzhou, People’s Republic of China;Department of Radiotherapy & Chemotherapy,Hwa Mei Hospital, University of Chinese Academy of Sciences, 315010, Ningbo, People’s Republic of China;Department of Radiotherapy, Ningbo Medical Center Lihuili Hospital, 315100, Ningbo, People’s Republic of China;Department of Radiotherapy, Shaoxing People’s Hospital (Shaoxing Hospital, Zhejiang University School of Medicine), 312000, Shaoxing, People’s Republic of China;Department of Radiotherapy, The First Affiliated Hospital of Wenzhou Medical University, 325100, Wenzhou, People’s Republic of China;Department of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, 310002, Hangzhou, People’s Republic of China;Department of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, 310002, Hangzhou, People’s Republic of China;Department of Cancer Medical Center, Affiliated Xiaoshan Hospital, Hangzhou Normal University, 311201, Hangzhou, People’s Republic of China;Department of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, 310002, Hangzhou, People’s Republic of China;Department of Oncology, Jiande Second People’s Hospital, 311604, Hangzhou, People’s Republic of China;

关键词: Almonertinib;    EGFR-TKI;    Radiotherapy;    Locally advanced NSCLC;    Radiation pneumonitis;   

DOI  :  10.1186/s12885-021-08266-w

来源: Springer

【 摘 要 】

BackgroundConcurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-small-cell lung cancer (NSCLC) patients. Several studies have shown a potential value of concurrent epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with thoracic radiotherapy in EGFR-mutated population, but a high risk of radiation pneumonitis raised a major concern. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI, with radiotherapy in locally advanced EGFR-mutated NSCLC patients.MethodsLocally advanced NSCLC patients harboring sensitive EGFR mutation will be included in this study. A radiotherapy plan will be made for each patient before treatment, and the lung V20 will be calculated. Patients with lung V20 ≥ 28% were enrolled in induction group (arm A), which almonertinib was given for 2 months followed by concurrent radiotherapy; patients with lung V20 < 28% were enrolled in concurrent group (arm B), which almonertinib was given concurrent with thoracic radiotherapy. The primary endpoint is the incidence of grade ≥ 3 radiation pneumonitis within 6 months post-radiotherapy, and the secondary endpoints are local control rate, progression-free survival, and overall survival.DiscussionThe safety and efficacy of third-generation EGFR-TKI concurrent with thoracic radiotherapy in locally advanced EGFR-mutated NSCLC is still unknown. We propose to conduct this phase 2 study evaluating the safety especially the radiation pneumonitis within 6 months post-radiotherapy. This trial protocol has been approved by the Ethics committee of Hangzhou cancer hospital. The ethics number is HZCH-2020-030.Trial registrationclinicaltrials.gov, NCT04636593. Registered 19 November 2020 - Retrospectively registered

【 授权许可】

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