PURPOSE:Erlotinib 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.
METHODS:Patients 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.
RESULTS:From 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.
CONCLUSIONS:This 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.
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【High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy.].
【在先前接受化学疗法治疗的一项扩大的访问计划研究中，厄洛替尼对台湾NSCLC患者的高疗效。】
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DOI：10.1016/j.lungcan.2008.02.023文章类型：杂志文章
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目的：厄洛替尼是第一种表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），已证明在非小细胞肺癌（NSCLC）患者中具有生存获益。在台湾的NSCLC患者中进行了一项开放标签的II期研究，以评估其疗效。
方法：IIIB / IV期NSCLC阶段已被证实接受过至少一线标准化疗或放疗的患者被纳入本研究。所有患者均口服厄洛替尼，剂量为150mg /天，直至疾病进展。
结果：从2005年5月到2006年7月，来自台湾14所医院的300名患者进入了研究。该分析基于299名接受至少一剂厄洛替尼的患者。最好的缓解率是在有可用响应数据的273例患者中，部分缓解率为29％，疾病稳定率为44％。非吸烟（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），较高等级的皮疹（p = 0.003）与治疗反应显着相关。皮疹是常见的不良事件（任何等级：84％，Gr 3-4：16％）。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，处于早期进展风险最大的患者是表现为鳞状细胞癌的低性能男性。
结论：这是台湾地区最大的非小细胞肺癌多中心前瞻性临床研究。结果表明，在先前接受过化学疗法或放射疗法治疗的大量台湾NSCLC患者中，厄洛替尼具有出色的缓解率，进展时间和总体生存率。
方法：IIIB / IV期NSCLC阶段已被证实接受过至少一线标准化疗或放疗的患者被纳入本研究。所有患者均口服厄洛替尼，剂量为150mg /天，直至疾病进展。
结果：从2005年5月到2006年7月，来自台湾14所医院的300名患者进入了研究。该分析基于299名接受至少一剂厄洛替尼的患者。最好的缓解率是在有可用响应数据的273例患者中，部分缓解率为29％，疾病稳定率为44％。非吸烟（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），较高等级的皮疹（p = 0.003）与治疗反应显着相关。皮疹是常见的不良事件（任何等级：84％，Gr 3-4：16％）。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，处于早期进展风险最大的患者是表现为鳞状细胞癌的低性能男性。
结论：这是台湾地区最大的非小细胞肺癌多中心前瞻性临床研究。结果表明，在先前接受过化学疗法或放射疗法治疗的大量台湾NSCLC患者中，厄洛替尼具有出色的缓解率，进展时间和总体生存率。
