埃克替尼辅助治疗II-IIIA期EGFR突变肺腺癌三年（ICWIP）：一项随机、双盲、安慰剂对照的3期试验
Three-year adjuvant treatment of icotinib in stage II-IIIA EGFR-mutated lung adenocarcinoma (ICWIP): a randomized, double-blind, placebo-controlled phase 3 trial.
作者
作者单位
- Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
- Department of Thoracic Surgery, China-Japan Friendship Hospital, Beijing, China.
- Department of Medical Oncology, Beijing Hospital, Beijing, China.
- Department of Oncology, The Fourth Medical Center of Chinese PLA General Hospital, Beijing, China.
- Department of Oncology, Beijing Chest Hospital, Capital Medical University, Beijing, China.
- Department of Oncology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
- Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
- Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
- Department of Thoracic Surgery, Peking University People's Hospital, Beijing, China.
- Department of Radiotherapy and Chemotherapy, Tangshan People's Hospital, Tangshan, China.
- Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. syuankai@cicams.ac.cn.
摘要
中文
这项多中心、双盲、安慰剂对照、随机3期试验（ICWIP）评估了完全切除的II-IIIA期表皮生长因子受体（EGFR）突变肺腺癌患者在接受四个周期辅助化疗后，三年埃克替尼辅助治疗与安慰剂相比的疗效和安全性（NCT02125240）。符合条件的患者按1:1随机分配接受埃克替尼（125mg，每日三次）或安慰剂治疗3年。主要终点是独立审查委员会（IRC）评估的无病生存期（DFS）。2014年6月3日至2018年11月15日期间，66名患者接受埃克替尼治疗，69名患者接受安慰剂治疗。在2024年10月31日的数据截止日期，埃克替尼组DFS的中位随访时间为78.3个月（四分位距[IQR] 71.3-95.6），安慰剂组为69.9个月（IQR 35.2-96.4）。IRC评估的中位DFS：埃克替尼组为48.2个月（95%置信区间[CI] 33.0-63.4），安慰剂组为20.0个月（95% CI 14.7-32.9）（风险比[HR] 0.54，95% CI 0.34-0.87；p=0.011）。3年DFS率：埃克替尼组58.5%（95% CI 39.9-73.1%），安慰剂组36.1%（95% CI 19.9-52.6%）；5年DFS率：埃克替尼组39.4%（95% CI 22.2-56.2%），安慰剂组25.8%（95% CI 8.7-47.1%）。两组中位总生存期（OS）均未达到（HR 0.84，95% CI 0.39-1.81；p=0.65）。估计5年OS率：埃克替尼组88.6%（95% CI 57.9-97.5%），安慰剂组83.4%（95% CI 57.7-94.2%）。埃克替尼组和安慰剂组分别有48.5%（32/66）和23.2%（16/69）的患者发生治疗相关不良事件。在完全切除的II-IIIA期EGFR突变肺腺癌且已完成四个周期辅助化疗的患者中，与安慰剂相比，埃克替尼辅助治疗三年显著改善了DFS，且安全性可控。
English
This multi-center, double-blind, placebo-controlled, randomized phase 3 trial (ICWIP) assessed the efficacy and safety of 3-year icotinib adjuvant treatment versus placebo in patients with completely resected stage II-IIIA epidermal growth factor receptor (EGFR) mutated lung adenocarcinoma who had completed four cycles of adjuvant chemotherapy (NCT02125240). Eligible patients were randomly assigned 1:1 to receive either icotinib (125 mg, three times daily) or placebo for 3 years. The primary endpoint was independent review committee (IRC)-assessed disease-free survival (DFS). Between June 3, 2014, and November 15, 2018, 66 patients received icotinib, and 69 patients received placebo. At the data cutoff date of October 31, 2024, the median follow-up for DFS was 78.3 months (interquartile range [IQR] 71.3-95.6) for the icotinib group and 69.9 months (IQR 35.2-96.4) for the placebo group. IRC-assessed median DFS was 48.2 months (95% confidence interval [CI] 33.0-63.4) in the icotinib group and 20.0 months (95% CI 14.7-32.9) in the placebo group (hazard ratio [HR] 0.54, 95% CI 0.34-0.87; p = 0.011). The 3-year DFS rates were 58.5% (95% CI 39.9-73.1%) for the icotinib group and 36.1% (95% CI 19.9-52.6%) for the placebo group, and the 5-year DFS rates were 39.4% (95% CI 22.2-56.2%) for the icotinib group and 25.8% (95% CI 8.7-47.1%) for the placebo group. The median overall survival (OS) was not reached in either group (HR 0.84, 95% CI 0.39-1.81; p = 0.65). The estimated 5-year OS rates were 88.6% (95% CI 57.9-97.5%) for the icotinib group and 83.4% (95% CI 57.7-94.2%) for the placebo group. Treatment-related adverse events occurred in 48.5% (32/66) and 23.2% (16/69) of the patients in the icotinib group and the placebo group, respectively. Three-year adjuvant treatment with icotinib significantly improved DFS compared to placebo in patients with completely resected stage II-IIIA EGFR-mutated lung adenocarcinoma who had completed four cycles of adjuvant chemotherapy, with a manageable safety profile.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 81.2
- 新锐分区
- 1区