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Efficacy and Safety of SH-1028 in Patients With EGFR T790M-Positive NSCLC: A Multicenter, Single-Arm, Open-Label, Phase 2 Trial.
Xiong, Anwen; Ren, Shengxiang; Liu, Huaimin; Miao, Liyun; Wang, Lei; Chen, Jianhua; Li, Wei; Li, Runpu; Wang, Xiang; Lu, Zhiwei; Wang, Donglin; Wu, Xiaohong; Liu, Zhihua; Xing, Ligang; Mao, Yimin; Liu, Chunling; Zeng, Aiping; Niu, Hongrui; Du, Yingying; Sun, Yuping; Pan, Yueyin; Hu, Yanping; Zhang, Xiaodong; Chen, Xueqin; Ma, Zhiyong; Li, Na; Zhang, Jianyong; Zhao, Min; Li, Xiaoling; Ye, Feng; Li, Mingjun; Yu, Guohua; Zhang, Xiaomeng; Min, Jie; Han, Dong; Li, Jin; Zhou, Caicun.
Afiliación
  • Xiong A; Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.
  • Ren S; Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.
  • Liu H; Department of Integrated Chinese and Western Medicine, Henan Provincial Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, People's Republic of China.
  • Miao L; Department of Respiratory, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.
  • Wang L; Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.
  • Chen J; Department of Thoracic Medicine, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, People's Republic of China.
  • Li W; Department of Respiratory, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People's Republic of China.
  • Li R; Department of Oncology, Baoding Second Central Hospital, Baoding, People's Republic of China.
  • Wang X; Department of Oncology, Xuzhou Central Hospital, Xuzhou, People's Republic of China.
  • Lu Z; Department of Respiratory, Yi Jishan Hospital, Wannan Medical College, Wuhu, People's Republic of China.
  • Wang D; Department of Oncology, The Affiliated Cancer Hospital of Chongqing University, Chongqing, People's Republic of China.
  • Wu X; Department of Oncology, The Affiliated Hospital of Jiangnan University, Wuxi, People's Republic of China.
  • Liu Z; Department of Thoracic Oncology Radiotherapy, Jiangxi Cancer Hospital, Nanchang, People's Republic of China.
  • Xing L; Department of Thoracic Oncology Radiotherapy, Shandong Cancer Hospital, Jinan, People's Republic of China.
  • Mao Y; Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, People's Republic of China.
  • Liu C; Department of pulmonary Medicine, Cancer Hospital Affiliated to Xinjiang Medical University, Urumqi, People's Republic of China.
  • Zeng A; Department of Respiratory Oncology, The Affiliated Tumor Hospital of Guangxi Medical University, Nanning, People's Republic of China.
  • Niu H; Department of Oncology, The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, People's Republic of China.
  • Du Y; Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.
  • Sun Y; Department of Oncology, Jinan Central Hospital, Jinan, People's Republic of China.
  • Pan Y; Department of Oncology Chemotherapy, Anhui Provincial Hospital, Hefei, People's Republic of China.
  • Hu Y; Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, People's Republic of China.
  • Zhang X; Department of Oncology, Nantong Tumor Hospital, Nantong, People's Republic of China.
  • Chen X; Department of Oncology, Hangzhou First People's Hospital, Hangzhou, People's Republic of China.
  • Ma Z; Department of Respiratory, Henan Cancer Hospital, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, People's Republic of China.
  • Li N; Department of Oncology, Suining Central Hospital, Suining, People's Republic of China.
  • Zhang J; Department of Respiratory and Critical Care Medicine, The Affiliated Hospital of Zunyi Medical University, Zunyi, People's Republic of China.
  • Zhao M; Department of Oncology, Hebei Chest Hospital, Shijiazhuang, People's Republic of China.
  • Li X; Department of Thoracic Medicine, Liaoning Cancer Hospital, Shenyang, People's Republic of China.
  • Ye F; Department of Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, People's Republic of China.
  • Li M; Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China.
  • Yu G; Department of Oncology, Weifang People's Hospital, Weifang, People's Republic of China.
  • Zhang X; Nanjing Sanhome Pharmaceutical Co., Ltd., Nanjing, People's Republic of China.
  • Min J; Nanjing Sanhome Pharmaceutical Co., Ltd., Nanjing, People's Republic of China.
  • Han D; Nanjing Sanhome Pharmaceutical Co., Ltd., Nanjing, People's Republic of China.
  • Li J; Department of Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.
  • Zhou C; Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China. Electronic address: caicunzhoudr@163.com.
J Thorac Oncol ; 17(10): 1216-1226, 2022 10.
Article en En | MEDLINE | ID: mdl-35798241
INTRODUCTION: As a novel third-generation EGFR tyrosine kinase inhibitor (TKI), SH-1028 (formerly oritinib) is developed to inhibit both sensitizing EGFR mutations and EGFR T790M mutation. METHODS: This was a multicenter, single-arm, open-label, phase 2 trial (NCT03823807). Eligible patients were those with advanced NSCLC with centrally confirmed EGFR T790M mutation who progressed after first- or second-generation EGFR TKIs or with primary EGFR T790M mutations. Each patient received SH-1028 tablets orally at 200 mg/d until disease progression or intolerable toxicity. Tumor response was evaluated every 6 weeks per the Response Evaluation Criteria in Solid Tumors, version 1.1. The primary end point was objective response rate by an independent review committee. The secondary end points were progression-free survival, overall survival (OS), disease control rate, safety, and so on. RESULTS: A total of 286 patients with EGFR T790M-positive advanced NSCLC were enrolled in this study, including 59 patients in part A (dose-verification study) and 227 patients in part B (second-line registration study). By data cutoff on September 17, 2021, the independent review committee-assessed objective response rate was 55.9% (95% confidence interval [CI]: 42.4-68.8) in part A and 60.4% (95% CI: 53.7-66.8) in part B. The median progression-free survival was 12.4 months (95% CI: 8.3-20.8) in part A and 12.6 months (95% CI: 9.7-15.3) in part B. The median OS was 26.0 months (95% CI: 23.3-not reached) in part A, and OS was immature in part B. Among the 286 patients, 44 of them experienced at least one grade 3 or higher treatment-related adverse event, with the most common ones as increased serum creatinine phosphokinase level (13 [4.5%]), diarrhea (six [2.1%]), and prolonged QT interval (three [1.0%]). Treatment-related skin rash was reported in 26 patients (9.1%), all grade 1 or 2. There was no interstitial lung disease reported in this study. CONCLUSIONS: SH-1028 is efficacious and tolerable in second-line treatment of patients with advanced NSCLC with positive EGFR T790M.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 3_ND Problema de salud: 3_diarrhea Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: J Thorac Oncol Año: 2022 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 3_ND Problema de salud: 3_diarrhea Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: J Thorac Oncol Año: 2022 Tipo del documento: Article
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