Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma.
Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma.
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DOI：
10.1056/nejmoa0810699
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发表时间：
2009-09-03
影响因子：
158.5
通讯作者：
Fukuoka, Masahiro
中科院分区：
文献类型：
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作者：
Mok, Tony S.;Wu, Yi-Long;Fukuoka, Masahiro
背景资料：以前的非对照研究表明，吉非替尼一线治疗对选定的非小细胞肺癌患者有效。方法：在这项3期开放标签研究中，我们将东亚地区既往未接受过治疗的晚期肺腺癌患者随机分为吉非替尼组，这些患者均为非吸烟者或轻度吸烟者（250 mg/天）（609例患者）或卡铂（计算剂量以产生5或6 mg/ml/min的曲线下面积）加紫杉醇（200 mg/m2体表面积）（608例患者）。主要终点是无进展生存率。结果：吉非替尼组12个月无进展生存率为24.9%，卡铂-紫杉醇组为6.7%。该研究达到了显示吉非替尼的非劣效性的主要目的，也显示了其在意向治疗人群中无进展生存期方面优于卡铂-紫杉醇（进展或死亡的风险比为0.74; 95%置信区间[CI]为0.65至0.85; P
Background: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer.Methods: In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival.Results: The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin-paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P