Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: Subset analysis from the ISEL study
Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small cell lung cancer: Subset analysis from the ISEL study
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DOI：
10.1097/01243894-200610000-00014
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发表时间：
2006-10-01
影响因子：
20.4
通讯作者：
Thatcher, Nick
中科院分区：
文献类型：
--
作者：
Chang, Alex;Parikh, Purvish;Thatcher, Nick
IRESSA在肺癌中的生存评估（ISEL） III期研究比较了吉非替尼（IRESSA）与安慰剂在难治性晚期非小细胞肺癌（NSCLC）患者中的疗效。虽然在总体ISEL人群中，吉非替尼和安慰剂的生存率没有统计学上的显著差异，但预先计划的亚群分析显示，从未吸烟的患者和亚洲血统的患者的生存率显著提高。方法：在ISEL中，1692名对最新化疗难以耐受或不耐受的患者随机接受吉非替尼（250mg /天）或安慰剂，外加最佳支持治疗。预先计划的亚组分析包括对亚洲血统患者的评估（n = 342）。结果：235名亚裔患者接受吉非替尼治疗，107名接受安慰剂治疗。在这些患者中，与安慰剂相比，吉非替曼治疗显著提高了生存率（风险比[HR]， 0.66； 95%可信区间[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，亚洲患者在吉非替尼治疗失败的时间上也有统计学上的显著改善（HR, 0.69; 95% Cl, 0.52, 0.91; p = 0.0084； 4.4个月对2.2个月），吉非替尼的客观缓解率高于安慰剂（12%对2%）。吉非替尼在亚洲患者中耐受性良好，皮疹和腹泻是最常见的不良事件。未观察到意外不良事件。结论：吉非替尼治疗与先前治疗过的难治性晚期非小细胞肺癌的亚洲亚组患者的生存率显著改善相关。
Introduction: 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 gefitimb 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.Methods: In ISEL, 1692 patients who were refractory to or intolerant of their latest chemotherapy were randomized to receive either gefitimb (250 mg/day) or placebo, plus best supportive care. Preplanned subgroup analyses included an assessment of patients who were of Asian origin (n = 342).Results: Two hundred thirty-five patients of Asian origin received gefitimb, and 107 received placebo. In these patients, treatment with gefitimb 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 gefitimb compared with placebo (HR, 0.69; 95% Cl, 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.Conclusions: 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.