Chang Alex, Parikh Purvish, Thongprasert Sumitra, Tan Eng Huat, Perng Reury-Perng, Ganzon Domingo, Yang Chih-Hsin, Tsao Chao-Jung, Watkins Claire, Botwood Nick, Thatcher Nick
Johns Hopkins Singapore International Medical Centre, Singapore.
J Thorac Oncol. 2006 Oct;1(8):847-55.
The IRESSA Survival Evaluation in Lung Cancer (ISEL) phase III study compared the efficacy of gefitinib (IRESSA) versus placebo in patients with refractory advanced non-small cell lung cancer (NSCLC). Although a statistically significant difference in survival was not seen between gefitinib and placebo in the overall ISEL population, preplanned subset analyses demonstrated a significant survival benefit in patients who had never smoked and in patients of Asian origin.
In ISEL, 1692 patients who were refractory to or intolerant of their latest chemotherapy were randomized to receive either gefitinib (250 mg/day) or placebo, plus best supportive care. Preplanned subgroup analyses included an assessment of patients who were of Asian origin (n = 342).
Two hundred thirty-five patients of Asian origin received gefitinib, and 107 received placebo. In these patients, treatment with gefitinib significantly improved survival compared with placebo (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.48, 0.91; p = 0.010; median survival, 9.5 versus 5.5 months). Patients of Asian origin also experienced statistically significant improvements in time to treatment failure with gefitinib compared with placebo (HR, 0.69; 95% CI, 0.52, 0.91; p = 0.0084; 4.4 versus 2.2 months), and objective response rates were higher with gefitinib than with placebo (12 versus 2%). Gefitinib was generally well tolerated in patients of Asian origin, with rash and diarrhea being the most common adverse events. No unexpected adverse events were observed.
Treatment with gefitinib was associated with a significant improvement in survival in a subgroup of patients of Asian origin with previously treated refractory advanced NSCLC.
肺癌易瑞沙生存评估（ISEL）III期研究比较了吉非替尼（易瑞沙）与安慰剂对难治性晚期非小细胞肺癌（NSCLC）患者的疗效。尽管在整个ISEL人群中，吉非替尼与安慰剂在生存方面未观察到统计学上的显著差异，但预先计划的亚组分析显示，从未吸烟的患者和亚洲裔患者有显著的生存获益。
在ISEL研究中，1692例对其最新化疗难治或不耐受的患者被随机分配接受吉非替尼（250毫克/天）或安慰剂，加最佳支持治疗。预先计划的亚组分析包括对亚洲裔患者（n = 342）的评估。
235例亚洲裔患者接受了吉非替尼治疗，107例接受了安慰剂治疗。在这些患者中，与安慰剂相比，吉非替尼治疗显著改善了生存（风险比[HR]，0.66；95%置信区间[CI]，0.48，0.91；p = 0.010；中位生存期，9.5个月对5.5个月）。与安慰剂相比，亚洲裔患者使用吉非替尼治疗失败时间也有统计学上的显著改善（HR，0.69；95%CI，0.52，0.91；p = 0.0084；4.4个月对2.2个月），且吉非替尼的客观缓解率高于安慰剂（12%对2%）。吉非替尼在亚洲裔患者中总体耐受性良好，皮疹和腹泻是最常见的不良事件。未观察到意外不良事件。
对于先前接受治疗的难治性晚期NSCLC亚洲裔患者亚组，吉非替尼治疗与生存显著改善相关。
