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发表于 2008-6-11 02:24:36
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来自: 美国
爱必妥对亚洲人无效
中位存活率(加爱必妥) 中位存活率(无爱必妥) 亚洲人例( 121 ) 17.6月
20.4 月
FLEX的随机多中心三期试药结果:第一 线治疗晚期非小细胞肺癌( NSCLC ) 爱必妥(cetuximab)联合顺铂/诺维本(CV)以及 仅用顺铂/诺维本(CV)的比较结果
子类别:转移性肺癌 类别: 肺癌-转移性肺癌 会议: 2008年asco年度会议
摘要: 3 引文: j临床肿瘤学26日: 2008年( 5月20日补编; abstr 3 ) 作者:r. pirker等 摘要:
背景: 表皮生 长因子受体( EGFR )失 调在非小细胞肺癌及相关较差的预后中是常见的。这个三期的研究,评估表皮生长因子受体-有针对性的单克隆抗体cetuximab联合顺铂/诺维本( CV)相比,变异系数,在 晚期非小细胞肺癌疗效和安全性。 方法: 具有可 检测的表皮生长因子受体的晚期非小细胞肺癌患者被随机地,以 1比1比例分为两组,1组采用 爱必妥( cetuximab) ( 400 mg/m2初始剂量,然后 250 mg/m2/wk ) ,另加 顺铂(80 mg/m2 D1的)和 诺维本(25 mg/m2于D1 , D8级) q3w 。2组仅用顺铂/诺维本 。主要 终点是整体存活率( OS)。其次是士无 进展生存,肿瘤反应,疾病控制,和安全性。分 层随机是由ecog性能状态( 0 / 1比2 )和 肿瘤分期(湿 iiib比四)。 结果: 1125
年患者随机分组:A组 557人 ,B组 568 , 70 %为男性,年 龄中位数59 ( 18-83 )岁,有 94%的是四期, 47
%腺癌 , 34 %的鳞状细胞癌(鳞状细胞癌) , 83 % ecog 0 / 1 。生存分析是 868事件发生后。
A组整体存活率显着改善,(分 层Log - rank检验)。 初步结果: 预定小组分析显示白种人比亚洲人受益更大,且结果独立于组织学的不同和一般预后较好。分析 辅助终点正在进行中。 结论: 爱必妥加顺铂/诺维本对比顺铂/诺维本显示了优越的生存率,对于表皮生长因子受体可检测的非小细胞肺癌患者。在 亚洲人和白人之间,结果有显着差异。这是首次研究显示,爱必妥对表皮生长因子受体-有针对性的代理人在结合铂为基础的化疗在先进的第一线非小细胞肺癌,不论组织学和临床证实的相关 cetuximab在非小细胞肺癌。 中位存活率(加爱必妥) 中位存活率(无爱必妥) HR(危险性比率)[ 95 % CI为] P值 所
有例( 1125) 11.3
10.1 0.871 [ 0.762
- 0.996 ] 0.0441 白种人例( 945 ) 10.5
9.1 0.
800 [ 0.692-0.924 ] 0.0025 与AC例( 412 )
12.0 10.2
0.809 [ 0.644-1.016 ] 0.0673 与鳞状细胞癌(
347例) 10.2 8.9
0.794 [ 0.626-1.007 ]
0.0567 亚洲人例( 121 ) 17.6
20.4
1.179 [ 0.730 - 1.905 ] 0.4992
FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).Sub-category: | | Category: | Lung Cancer--Metastatic Lung Cancer | Meeting: | |
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 |  |  | Abstract No: | 3 | Citation: | J Clin Oncol 26: 2008 (May 20 suppl; abstr 3) | Author(s): | R. Pirker, A. Szczesna, J. von Pawel, M. Krzakowski, R. Ramlau, K. Park, U. Gatzemeier, E. Bajeta, M. Emig, J. R. Pereira | Abstract: | Background: Epidermal growth factor receptor (EGFR) dysregulation is common in NSCLC and is associated with poorer prognosis. This phase III study assessed the efficacy and safety of the EGFR-targeted monoclonal antibody cetuximab in combination with cisplatin/vinorelbine (CV) compared with CV alone in advanced NSCLC. Methods: Patients with EGFR-detectable advanced NSCLC were randomized 1:1 to cetuximab (400 mg/m2 initial dose, then 250 mg/m2/wk) plus C (80 mg/m2 d1) and V (25 mg/m2 d1, d8) q3w (arm A) or CV alone (arm B). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival, tumor response, disease control, and safety. Randomization was stratified by ECOG performance status (0/1 vs 2) and tumor stage (wet IIIb vs IV). Results: 1,125 patients were randomized: 557 to arm A, 568 to arm B, 70% male, median age 59 (18-83) years, 94% stage IV, 47% adenocarcinoma (AC), 34% squamous cell carcinoma (SCC), 83% ECOG 0/1. Survival analysis was performed after 868 events had occurred. OS was significantly improved in arm A (stratified log-rank test). Preliminary results of prespecified subgroup analyses suggest a greater benefit in Caucasians independent of histology and a general better prognosis in Asians. Analyses of secondary endpoints are ongoing. Conclusions: Cetuximab plus CV demonstrated superior survival over CV alone in patients with advanced EGFR-detectable NSCLC. There was a remarkable difference between the outcome of Asian and Caucasian patients. This is the first study to demonstrate a survival benefit of an EGFR-targeted agent in combination with platinum-based chemotherapy in advanced first-line NSCLC irrespective of histology and confirms the clinical relevance of cetuximab in NSCLC.
| Median OS (mo) Arm A | Median OS (mo) Arm B | HR [95% CI] | p-value | All (n=1125) | 11.3 | 10.1 | 0.871 [0.762- 0.996] | 0.0441 | Caucasians (n=945) | 10.5 | 9.1 | 0.800 [0.692-0.924] | 0.0025 | with AC (n=412) | 12.0 | 10.2 | 0.809 [0.644-1.016] | 0.0673 | with SCC (n=347) | 10.2 | 8.9 | 0.794 [0.626-1.007] | 0.0567 | Asians (n=121) | 17.6 | 20.4 | 1.179 [0.730- 1.905] | 0.4992 | HR, hazard ratio |
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