Background and objective: As the first epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in China, icotinib shows promising anticancer activity in vitro and vivo. The phase III clinical study (ICOGEN) showed that icotinib has a good efficacy and tolerability in Chinese patients with advanced non-small cell lung cancer (NSCLC) compared with gefitinib. This retrospective study aims to evaluate the efficacy and tolerability of icotinib monotherapy for advanced NSCLC patients with EGFR mutation and wild-type patients in our hospital.
Methods: Patients with advanced NSCLC who were treated with icotinib in Zhejiang Cancer Hospital were retrospectively analyzed from August, 2011 to August, 2012. Survival was estimated using Kaplan-Meier analysis and Log-rank tests.
Results: The clinical data of 49 patients (13 with wild-type and 36 with EGFR mutation) with NSCLC were enrolled in the current study. The patients' overall objective response rate (ORR) was 58.3% and the disease control rate (DCR) in 36 EGFR mutation patients was 88.9%. The ORR was 7.7% and DCR was 53.8% in the wild-type patients. Median progression-free survival (PFS) with icotinib treatment in EGFR mutation patients was 9.5 months and 2.2 months in wild-type patients (P<0.001). Nineteen patients with EGFR mutation received icotinib as first-line and 17 in further-line treatment. The PFS was 9.5 months in the first-line and 8.5 months for second-line or further-line patients (P=0.41). Median overall survival (OS) in EGFR mutation patients was not reached, but was 12.6 months in wild-type patients. Most of the drug-related adverse events were mild (grade I or II) and reversible with no grade IV toxicity.
Conclusions: Icotinib monotherapy showed significant antitumor activity in advanced NSCLC EGFR mutation patients. The toxicity was well tolerated and acceptable.
背景与目的: 埃克替尼是国内第一个口服的表皮生长因子受体（epidermal growth factor receptor, EGFR）酪氨酸激酶受体抑制剂，在体内外实验研究中显示出对非小细胞肺癌的明显抑制作用。Ⅲ期临床研究ICOGEN显示埃克替尼对复治晚期非小细胞肺癌疗效不劣于吉非替尼。本研究探讨在晚期非小细胞肺癌明确EGFR状态的患者中（EGFR野生型和突变型）埃克替尼的疗效和安全性。
方法: 回顾性分析2011年8月-2012年8月在浙江省肿瘤医院就诊并行埃克替尼治疗的晚期非小细胞肺癌患者，Kaplan-Meier法进行生存分析和比较。
结果: 49例患者明确了EGFR突变状态并行埃克替尼治疗，49例患者中13例为野生型，36例为突变型。突变患者的客观缓解率和疾病控制率分别为58.3%和88.9%，野生型患者的客观缓解率和疾病控制率分别为7.7%和53.8%。突变和野生型患者的中位无进展生存期为9.5个月和2.2个月（P < 0.001）。36例突变患者中一线治疗19例，二线及二线以上患者17例。一线和复治患者的中位无进展生存期（progression-free survival, PFS）分别为9.5个月和8.5个月（P=0.41）。突变型患者的中位总生存期（overall survival, OS）尚未达到，野生型患者的OS为12.6个月。患者的不良反应以皮疹和腹泻为主，但多为轻到中度。
结论: 埃克替尼在EGFR突变患者中的疗效较好，可以作为EGFR突变患者的优选方案。患者的毒副反应多数可以耐受。