Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Lung Cancer. 2012 Jan;75(1):82-8. doi: 10.1016/j.lungcan.2011.05.022.
Gefitinib and erlotinib are potent EGFR TKIs, with antitumor activity. In this randomized, single-center, non-comparative phase II trial, the efficacy and safety of gefitinib and erlotinib was evaluated as the second-line therapy for advanced non-small cell lung cancer (NSCLC).
Patients with locally advanced, metastatic stage IIIB/IV NSCLC who failed first-line chemotherapy and had either EGFR mutation or at least two out of three clinical factors associated with higher incidence of EGFR mutations (female, adenocarcinoma histology, and never-smoker) were eligible.
A total of 96 (48 per arm) patients were randomly assigned to gefitinib- or erlotinib-arm, respectively. Baseline characteristics were well-balanced between the two arms. The response rates (RR) were 47.9% in the gefitinib arm and 39.6% in the erlotinib arm. Median PFS was 4.9 months (95% CI, 1.3-8.5) in the gefitinib arm and 3.1 months (95% CI, 0.0-6.4) in the erlotinib arm. The most common grade 3/4 toxicity was skin rash. Exploratory analyses showed that there was no significant difference in RR and PFS in the gefitinib arm compared to the erlotinib arm (RR (%) 47.9 vs. 39.6, p=0.269; median survival (months) 4.9 vs. 3.1, p=0.336). There was no significant difference in QOL between the two arms.
Both gefitinib and erlotinib showed effective activity and tolerable toxicity profiles as second-line treatment for the selected population of NSCLC. We may consider conducting a phase III trial to directly compare the efficacy and toxicity between gefitinib and erlotinib in an enriched patient population.
吉非替尼和厄洛替尼是有效的 EGFR-TKI，具有抗肿瘤活性。在这项随机、单中心、非对照的 II 期试验中，评估了吉非替尼和厄洛替尼作为晚期非小细胞肺癌（NSCLC）二线治疗的疗效和安全性。
局部晚期、转移性 IIIB/IV 期 NSCLC 患者，一线化疗失败，且具有 EGFR 突变或至少三个与更高 EGFR 突变发生率相关的临床因素中的两个（女性、腺癌组织学和从不吸烟者），符合条件。
共 96 例（每组 48 例）患者被随机分配至吉非替尼或厄洛替尼组。两组间基线特征平衡良好。吉非替尼组的缓解率（RR）为 47.9%，厄洛替尼组为 39.6%。吉非替尼组的中位无进展生存期（PFS）为 4.9 个月（95%CI，1.3-8.5），厄洛替尼组为 3.1 个月（95%CI，0.0-6.4）。最常见的 3/4 级毒性是皮疹。探索性分析显示，吉非替尼组与厄洛替尼组在 RR 和 PFS 方面无显著差异（RR（%）47.9 与 39.6，p=0.269；中位生存期（月）4.9 与 3.1，p=0.336）。两组间 QOL 无显著差异。
吉非替尼和厄洛替尼作为选定 NSCLC 人群的二线治疗，均显示出有效的活性和可耐受的毒性特征。我们可能会考虑开展一项 III 期试验，直接比较吉非替尼和厄洛替尼在富集患者人群中的疗效和毒性。
