High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy.
High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy.
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在一项扩大使用计划研究中，厄洛替尼对既往接受过化疗的台湾 NSCLC 患者具有高效功效。
DOI：
10.1016/j.lungcan.2008.02.023
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发表时间：
2008
期刊：
影响因子：
5.3
通讯作者：
W. Kao
中科院分区：
文献类型：
--
作者：
R. Perng;Chih‐Hsin Yang;Yuh;G. Chang;Meng;R. Hsieh;N. Chu;R. Lai;W. Su;C. Tsao;T. Hsia;Hao‐Cheng Chen;Chih;Ming;Jui;M. Ho;C. Chung;Chong;Wen‐Cheng Chang;H. Kuo;Chih;Zhong‐Zhe Lin;W. Kao
目的厄洛替尼是第一个表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），已证明对非小细胞肺癌（NSCLC）患者具有生存获益。在台湾 NSCLC 患者中进行了一项开放标签 II 期研究，以评估其疗效。方法将接受过至少一种标准化疗或放疗的已证实的 IIIB/IV 期 NSCLC 患者纳入本研究。所有患者均口服厄洛替尼，150mg/天，直至疾病进展。结果2005年5月至2006年7月，来自台湾14家医院的300名患者入组。该分析基于 299 名至少接受一剂厄洛替尼治疗的患者。在 273 名有缓解数据的患者中，最佳缓解率为 29% 的部分缓解和 44% 的疾病稳定。不吸烟 (p=0.033)、腺癌/BAC (p=0.0027)、女性 (p=0.0013)、年龄小于 65 岁 (p=0.0115)、IV 期 (p=0.0492)、皮疹患者 (p=0.0216) 和较高级别皮疹 (p=0.003) 与对治疗的反应显着相关治疗。皮疹是一种常见的不良事件（任何级别：84%，3-4 级：16%）。疾病进展的中位时间为 5.6 个月。无进展生存期的 Cox 回归模型显示，早期进展风险最高的患者是患有鳞状细胞癌的低体力状态男性。结论这是台湾最大的 NSCLC 多中心前瞻性临床研究。结果表明，厄洛替尼在大量先前接受过化疗或放疗的台湾 NSCLC 患者中具有出色的缓解率、进展时间和总生存率。
PURPOSEErlotinib is the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) which has demonstrated a survival benefit in non-small-cell lung cancer (NSCLC) patients. An open label phase II study was conducted in Taiwanese patients with NSCLC to evaluate its efficacy.METHODSPatients with proven stage IIIB/IV NSCLC who had received at least one line of standard chemotherapy or radiotherapy were enrolled into this study. All patients were given oral erlotinib, 150mg/day till disease progression.RESULTSFrom May 2005 to July 2006, 300 patients were entered from 14 hospitals in Taiwan. This analysis was based on 299 patients who received at least one dose of erlotinib. The best response rates were a 29% partial response and 44% stable disease in 273 patients who had response data available. Non-smoking (p=0.033), adenocarcinoma/BAC (p=0.0027), female (p=0.0013), aged less than 65 years (p=0.0115), stage IV (p=0.0492), patients with skin rash (p=0.0216), and a higher grade of skin rash (p=0.003) were significantly correlated with response to treatment. Skin rash was a common adverse event (any grade: 84%, Gr 3–4: 16%). The median time to disease progression was 5.6 months. Cox regression model for progression free survival showed patients most at risk of early progression were males of low performance status having squamous cell carcinoma.CONCLUSIONSThis was the largest multicenter prospective clinical study of NSCLC in Taiwan. The results demonstrated the excellent response rates, time-to-progression and overall survival of erlotinib in a large population of Taiwanese NSCLC patients who had been previously treated with chemotherapy or radiotherapy.
影响因子：
158.5
作者：
Schiller, JH;Harrington, D;Johnson, DH
通讯作者：
Johnson, DH