Department of Thoracic Surgery II, Beijing Cancer Hospital, Beijing.
Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Hebi.
ESMO Open. 2023 Aug;8(4):101565. doi: 10.1016/j.esmoop.2023.101565. Epub 2023 Jun 20.
Despite the prolonged median disease-free survival (DFS) by adjuvant targeted therapy in non-small-cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations, the relationship between the treatment duration and the survival benefits in patients remains unknown.
In this multicenter, randomized, open-label, phase II trial, eligible patients aged 18-75 years with EGFR-mutant, stage II-IIIA lung adenocarcinoma and who had not received adjuvant chemotherapy after complete tumor resection were enrolled from eight centers in China. Patients were randomly assigned (1 : 1) to receive either 1-year or 2-year icotinib (125 mg thrice daily). The primary endpoint was DFS assessed by investigator. The secondary endpoints were overall survival (OS) and safety. This study was registered at ClinicalTrials.gov (NCT01929200).
Between September 2013 and October 2018, 109 patients were enrolled (1-year group, n = 55; 2-year group, n = 54). Median DFS was 48.9 months [95% confidence interval (CI) 33.1-70.1 months] in the 2-year group and 32.9 months (95% CI 26.6-44.8 months) in the 1-year group [hazard ratio (HR) 0.51; 95% CI 0.28-0.94; P = 0.0290]. Median OS for patients was 75.8 months [95% CI 64.4 months-not evaluable (NE)] in the 2-year group and NE (95% CI 66.3 months-NE) in the 1-year group (HR 0.34; 95% CI 0.13-0.95; P = 0.0317). Treatment-related adverse events (TRAEs) were observed in 41 of 55 (75%) patients in the 1-year group and in 36 of 54 (67%) patients in the 2-year group. Grade 3-4 TRAEs occurred in 4 of 55 (7%) patients in the 1-year group and in 3 of 54 (6%) patients in the 2-year group. No treatment-related deaths or interstitial lung disease was reported.
Two-year adjuvant icotinib was shown to significantly improve DFS and provide an OS benefit in EGFR-mutant, stage II-IIIA lung adenocarcinoma patients compared with 1-year treatment in this exploratory phase II study.
尽管表皮生长因子受体（EGFR）突变的非小细胞肺癌患者接受辅助靶向治疗后中位无病生存期（DFS）延长，但治疗持续时间与患者生存获益之间的关系仍不清楚。
在这项多中心、随机、开放标签、二期临床试验中，纳入了 8 个中心的年龄在 18-75 岁之间、有 EGFR 突变、II 期-IIIA 期肺腺癌且完全肿瘤切除后未接受辅助化疗的患者。患者被随机分配（1:1）接受 1 年或 2 年的伊可替尼（125 mg，每日 3 次）治疗。主要终点为研究者评估的 DFS。次要终点为总生存期（OS）和安全性。该研究在 ClinicalTrials.gov（NCT01929200）注册。
2013 年 9 月至 2018 年 10 月，共纳入 109 例患者（1 年组 n=55；2 年组 n=54）。2 年组的中位 DFS 为 48.9 个月（95%CI 33.1-70.1 个月），1 年组为 32.9 个月（95%CI 26.6-44.8 个月）[风险比（HR）0.51；95%CI 0.28-0.94；P=0.0290]。2 年组患者的中位 OS 为 75.8 个月（95%CI 64.4 个月-NE），1 年组为 NE（95%CI 66.3 个月-NE）（HR 0.34；95%CI 0.13-0.95；P=0.0317）。1 年组有 41 例（75%）患者和 2 年组有 36 例（67%）患者发生治疗相关不良事件（TRAEs）。1 年组有 4 例（7%）患者和 2 年组有 3 例（6%）患者发生 3-4 级 TRAEs。未报告 TRAE 相关死亡或间质性肺病。
在这项探索性二期研究中，与 1 年治疗相比，EGFR 突变、II 期-IIIA 期肺腺癌患者接受 2 年伊可替尼辅助治疗可显著改善 DFS，并获得 OS 获益。
