Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Germany.
J Thorac Oncol. 2010 Oct;5(10):1616-22. doi: 10.1097/JTO.0b013e3181f1c7b0.
Erlotinib is a small molecule inhibitor of epidermal growth factor receptor tyrosine-kinase activity that has been shown to significantly increase survival for patients with previously treated advanced non-small cell lung cancer. Here, we report safety and efficacy data from a large, global, open-label, phase IV trial of erlotinib (Tarceva Lung Cancer Survival Treatment).
Patients who had previously failed on chemotherapy or radiotherapy and were unsuitable for these treatments were treated with oral erlotinib (150 mg/d) until disease progression or unacceptable toxicity.
The disease control rate was 69% in 5394 patients for whom best response data were available. Survival data were available for 6580 patients. Median progression-free and overall survival times were 3.25 months and 7.9 months, respectively. The 1-year survival rate was 37.7%. Among the 6580 patients included in the safety analysis, 799 (12%) experienced one or more erlotinib-related adverse events (AEs, other than prespecified AEs defined in the protocol), and only 4% experienced an erlotinib-related serious AE. Of the 6580 patients for whom data were available, dose reductions were reported in 1096 (17%), the majority (95%) due to an erlotinib-related AE (most commonly rash 65% or diarrhea 10%). Treatment was discontinued for 337 patients (5%) because of erlotinib-related AEs. Incidence of erlotinib-related rash was investigated as a separate end point. Seventy-one percent of patients for whom data were available experienced erlotinib-related rash; of these, the majority of cases were grade 1/2 (59%).
These data confirm the favorable efficacy and safety profile of erlotinib in a large heterogeneous non-small cell lung cancer population.
厄洛替尼是一种小分子表皮生长因子受体酪氨酸激酶抑制剂，已被证明可显著提高先前接受治疗的晚期非小细胞肺癌患者的生存率。在这里，我们报告了一项大型、全球性、开放性、四期临床试验的安全性和疗效数据，该试验使用厄洛替尼（Tarceva 肺癌生存治疗）治疗。
先前接受化疗或放疗失败且不适合这些治疗的患者接受口服厄洛替尼（150mg/d）治疗，直至疾病进展或出现不可接受的毒性。
在可获得最佳反应数据的 5394 名患者中，疾病控制率为 69%。有 6580 名患者可获得生存数据。无进展生存期和总生存期的中位数分别为 3.25 个月和 7.9 个月。1 年生存率为 37.7%。在纳入安全性分析的 6580 名患者中，799 名（12%）发生了 1 次或多次与厄洛替尼相关的不良事件（AE，除方案中预先规定的 AE 外），仅有 4%发生了与厄洛替尼相关的严重 AE。在可获得数据的 6580 名患者中，1096 名（17%）报告了剂量减少，其中大多数（95%）是由于与厄洛替尼相关的 AE（最常见的是皮疹 65%或腹泻 10%）。由于与厄洛替尼相关的 AE，有 337 名患者（5%）停止治疗。厄洛替尼相关皮疹的发生率被作为一个单独的终点进行研究。在可获得数据的患者中，71%发生了与厄洛替尼相关的皮疹；其中，大多数病例为 1/2 级（59%）。
这些数据证实了厄洛替尼在大型异质性非小细胞肺癌人群中的良好疗效和安全性。
