Thoracic Radiotherapy Improves the Survival in Patients With <i>EGFR</i> -Mutated Oligo-Organ Metastatic Non–Small Cell Lung Cancer Treated With Epidermal Growth Factor Receptor–Tyrosine Kinase Inhibitors: A Multicenter, Randomized, Controlled, Phase III Trial
Abstract
PURPOSE This multicenter, randomized, phase III clinical trial (Northern Radiation Oncology Group of China-002) focused on patients with oligo-organ metastatic non–small cell lung cancer (NSCLC) who have epidermal growth factor receptor ( EGFR ) mutations. We aimed to investigate whether first-line concurrent thoracic radiotherapy (TRT) and EGFR-tyrosine kinase inhibitors (TKIs), compared with TKIs alone, could achieve better survival. MATERIALS AND METHODS The patients in the TKI plus TRT group received 60 Gy to primary lung tumor and positive regional lymph nodes. Radiotherapy for metastases to other sites was determined by clinicians. The primary end point was the progression-free survival (PFS). Secondary end points included overall survival (OS) and treatment-related adverse events (TRAEs). The first and second interim analyses were performed in March 2021 and March 2022. RESULTS Between April 14, 2016, and February 25, 2022, a total of 118 patients were enrolled. Compared with the TKI alone group, the TKI plus TRT group achieved significantly better PFS (hazard ratio [HR], 0.57; P = .004) and OS (HR, 0.62; P = .029). The median PFS was 10.6 months in the TKI alone group and 17.1 months in the TKI plus TRT group. The median OS was 26.2 months and 34.4 months in the TKI alone group and TKI plus TRT group, respectively. The TKI plus TRT group showed better local control but was associated with a higher incidence of severe TRAEs (11.9% v 5.1%). CONCLUSION For patients with EGFR -mutated oligo-organ metastatic NSCLC treated with first-line EGFR-TKIs, concurrent TRT improves the PFS and OS, and TRAEs are acceptable and tolerable.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (37)
Hongfu Sun
Minghao Li
Interdisciplinary Graduate School of Engineering Sciences, Kyushu University, 6−1 Kasuga-koen, Kasuga, Fukuoka 816-8580, Japan
Wei Huang
Jian Zhang
Shihong Wei
Gansu Provincial Cancer Hospital, Lanzhou, China
Yongjing Yang
Department of Radiation Oncology, Jilin Cancer Hospital, Changchun, China
Zhongtang Wang
Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jinan, China
Shucheng Ye
Heyi Gong
Department of Oncology, Central Hospital Affiliated to Shandong First Medical University, Jinan, China
Yaowen Zhang
State Key Laboratory of Inorganic Synthesis and Preparative Chemistry, College of Chemistry
Jie Li
Haixia Song
Lifang Wang
Xiangming Chen
Department of Clinical Oncology, Taian City Central Hospital, Taian, China
Haiqun Lin
Department of Oncology, the Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China
Gaofeng Ding
Department of Radiation Oncolog, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China
Hongwei Li
Peking University , , ,
Anping Zheng
Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China
Xuezhen Ma
ShaoShui Chen
Department of Radiation Oncology, Binzhou Medical University Hospital, Binzhou, China
Liping Liu
Kaixian Zhang
Department of Radiation Oncology, Tengzhou Central People's Hospital, Tengzhou, China
Chengrui Fu
Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China
Wenzhi Liu
Department of Radiation Oncology, Shenzhen Traditional Chinese Medicine Hospital, the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, China
Jing Wang
Hunan Cancer Hospital Changsha China
Xiaqin Zhang
Department of Radiation Oncology, Shanxi Province Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/ Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China
Tingting Liu
Dan Han
School of Materials Science and Engineering
Qian Zhao
Zhejiang University , , ,
Peipei Wu
Cold Spring Harbor Laboratory
Qianqian Yuan
Lijun Tian
Ping Zhang
Xueqin Wu
Fei Chen
Zicheng Zhang
College of Advanced Interdisciplinary Studies, National University of Defense Technology , Changsha 410073,
Baosheng Li
Chongqing University , , ,