详情页 - 河北医科大学第四医院机构库

当前位置：首页 > 详情页

Routine-Dose and High-Dose Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 21-L858R Mutation: the Randomized, Phase II, INCREASE Trial

5| 导出 | 链接全文 |

文献详情

资源类型：

WOS体系：

Pubmed体系：

收录情况： ◇ SCIE

作者：

机构： [1]Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China. [2]Respiratory Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China. [3]Department of Medical Oncology, The Forth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang, China. [4]State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [5]Hebei Key Laboratory of Cancer Radiotherapy and Chemotherapy, Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China. [6]Department of Respiratory Medicine, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [7]Department of Oncology, Hebei Chest Hospital, Shijiazhuang, Hebei, China. [8]Department of Medical Oncology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China. [9]Department of Oncology, Affiliated People's Hospital of Hebei Medical University, Shijiazhuang, China. [10]Department of Oncology, Tianjin Medical University General Hospital, Tianjin, China. [11]Department of Head and Neck and Genito- Urinary Oncology, Harbin Medical University Cancer Hospital, Harbin, China. [12]Department of Medical Oncology, People's Hospital of Inner Mongolia Autonomous Region, Hohhot, China. [13]Department of Medical Oncology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. [14]Department of Oncology, Beijing Hospital, National Center of Gerontology, Beijing, China. [15]Department of Respiratory Medicine, Tianjin People's Hospital, Tianjin, China. [16]Respiratory Department, Sixth Medical Center of PLA General Hospital, Beijing, China. [17]Department of Medical Oncology, Xingtai People's Hospital of Hebei Medical University, Xingtai, China. [18]Department of Oncology, Peking University Third Hospital, Beijing, China. [19]Betta Pharmaceutical Co., Ltd., Hangzhou, China.

出处：

DOI：

ISSN：

摘要：

Purpose: Our primary purpose is to explore safety and efficacy of high-dose icotinib in comparison with routine-dose icotinib in patients with non-small cell lung cancer (NSCLC) harboring 21-L858R mutation. Patients and Methods: Patients with treatment-nave, EGFR-mutant (21-L858R or exon 19 deletion at 2:1) NSCLC were enrolled. Patients with 21-L858R mutation were randomized to receive routine-dose icotinib (125 mg, thrice daily; L858R-RD) or high-dose icotinib (250 mg, thrice daily; L858R-HD), whereas patients with exon 19 deletion received only routine-dose icotinib (19-Del-RD) until progression, death, or unacceptable toxicity. The primary endpoint was median progression-free survival (mPFS), assessed by an independent review committee. Results: From May 2015 to November 2017, 253 patients (86 in L858R-RD: 90 in L858R-HD; and 77 in 19-Del-RD) were enrolled. The mPFS in L858R-HD group was similar to that in 19-Del-RD group (12.9 months and 12.5 months, respectively) and was significantly longer than that in L858R-RD group [12.9 months vs. 9.2 months, hazard ratio (HR): 0.75; 95% confidence interval (CI), 0.53-1.05]. A longer but statistically nonsignificant mPFS was observed between 19-Del-RD and L858R-RD groups (12.5 months vs. 9.2 months, HR: 0.80; 95% CI, 0.57-1.13). A higher objective response rate (ORR) was observed in L858R-HD group compared with L858R-RD group (73% vs. 48%), also between 19-Del-RD and L858R-RD groups (75% vs. 48%). Similar incidences of grade 3/4 toxicities were observed among the three treatment groups. Conclusions: High-dose icotinib improved mPFS and ORR in patients with NSCLC harboring 21-L858R mutation with acceptable tolerability, which could be a new therapeutic option for this patient population.

基金：

语种：

被引次数：

WOS：

PubmedID：

中科院分区：

出版当年[2020]版：

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 | 2 区肿瘤学

JCR分区：

出版当年[2020]版：

Q1 ONCOLOGY

最新[2023]版：

Q1 ONCOLOGY

影响因子： 10.4 最新[2023版] 11.3 最新五年平均 12.531 出版当年[2020版] 12.836 出版当年五年平均 10.107 出版前一年[2019版] 13.801 出版后一年[2021版]

第一作者：

第一作者机构： [1]Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.

共同第一作者：

通讯作者：

通讯机构： [1]Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China. [*1]Beijing Chest Hospital, Capital Medical University, Beijing, 101149, China.

推荐引用方式(GB/T 7714)：

APA：

MLA：