Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy
Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy
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DOI：
10.1016/j.lungcan.2011.05.022
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发表时间：
2012-01-01
期刊：
影响因子：
5.3
通讯作者：
Ahn, Myung-Ju
中科院分区：
文献类型：
--
作者：
Kim, Seung Tae;Uhm, Ji Eun;Ahn, Myung-Ju
目的：吉非替尼和厄洛替尼均为强效EGFR TKI，具有抗肿瘤活性。本研究为随机、单中心、非比较性II期临床试验，评价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，首次失败的转移性IIIB/IV期NSCLC患者-线化疗，并且有EGFR突变或至少三分之二的与EGFR突变发生率较高相关的临床因素结果：共有96例（每组48例）患者被随机分配到吉非替尼或厄洛替尼组。两组之间的基线特征平衡良好。吉非替尼组和厄洛替尼组的缓解率（RR）分别为47.9%和39.6%。吉非替尼组和厄洛替尼组的中位PFS分别为4.9个月（95%CI，1.3-8.5）和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的RR和PFS无显著差异（RR（%）47.9 vs. 39.6，p = 0.269;中位生存期（月）4.9 vs. 3.1，p = 0.336）。两组患者的生活质量无显著性差异。结论：吉非替尼和厄洛替尼作为非小细胞肺癌的二线治疗，均具有较好的疗效和耐受性。我们可能会考虑进行一项III期临床试验，在丰富的患者人群中直接比较吉非替尼和厄洛替尼的疗效和毒性。(C)2011爱思唯尔爱尔兰有限公司保留所有权利。
Purpose: 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 and methods: 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.Results: 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% Cl, 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.Conclusion: 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. (C) 2011 Elsevier Ireland Ltd. All rights reserved.