Department of Thoracic Surgery, Xuan Wu Hospital, Capital Medical University, Beijing, China.
Thorac Cancer. 2016 Sep;7(5):543-548. doi: 10.1111/1759-7714.12365. Epub 2016 Jun 13.
Epidermal growth factor receptor (EGFR) mutations occur in about 50% of Asian patients with non-small cell lung cancer (NSCLC). Patients with advanced NSCLC and EGFR mutations derive clinical benefit from treatment with EGFR-tyrosine kinase inhibitors (TKIs). This study assessed the efficacy and safety of adjuvant icotinib without chemotherapy in EGFR-mutated NSCLC patients undergoing resection of stage IB-IIIA.
Our retrospective study enrolled 20 patients treated with icotinib as adjuvant therapy. Survival factors were evaluated by univariate and Cox regression analysis.
The median follow-up time was 30 months (range 24-41). At the data cut-off, five patients (25%) had recurrence or metastasis and one patient had died of the disease. The two-year disease-free survival (DFS) rate was 85%. No recurrence occurred in the high-risk stage IB subgroup during the follow-up period. In univariate analysis, the micropapillary pattern had a statistically significant effect on DFS ( P = 0.040). Multivariate logistic regression analysis showed that there was no independent predictor. Drug related adverse events (AEs) occurred in nine patients (45.0%). The most common AEs were skin-related events and diarrhea, but were relatively mild. No grade 3 AEs or occurrences of intolerable toxicity were observed.
Icotinib as adjuvant therapy is effective in patients harboring EGFR mutations after complete resection, with an acceptable AE profile. Further trials with larger sample sizes might confirm the efficiency of adjuvant TKI in selected patients.
表皮生长因子受体（EGFR）突变发生在约 50%的亚洲非小细胞肺癌（NSCLC）患者中。晚期 NSCLC 患者和 EGFR 突变患者从 EGFR-酪氨酸激酶抑制剂（TKI）治疗中获得临床获益。本研究评估了表皮生长因子受体突变的 NSCLC 患者在接受 IB 期-IIIA 期切除术后，无化疗情况下辅助伊可替尼的疗效和安全性。
我们的回顾性研究纳入了 20 例接受伊可替尼辅助治疗的患者。通过单因素和 Cox 回归分析评估生存因素。
中位随访时间为 30 个月（范围 24-41）。在数据截止时，5 例患者（25%）出现复发或转移，1 例患者死于该疾病。两年无病生存率（DFS）为 85%。在随访期间，高危 IB 期亚组中无复发。单因素分析显示，微乳头状模式对 DFS 有统计学意义（P=0.040）。多因素 logistic 回归分析显示，没有独立的预测因素。9 例患者（45.0%）发生药物相关不良事件（AE）。最常见的 AE 是皮肤相关事件和腹泻，但相对较轻。未观察到 3 级 AE 或不可耐受的毒性发生。
伊可替尼作为辅助治疗在完全切除后携带 EGFR 突变的患者中是有效的，其 AE 谱可接受。进一步的临床试验，样本量更大，可能会证实辅助 TKI 在选定患者中的有效性。
