Adjuvant Cisplatin and Vinorelbine for Completely Resected Non-small Cell Lung Cancer Subgroup Analysis of the Lung Adjuvant Cisplatin Evaluation
Adjuvant Cisplatin and Vinorelbine for Completely Resected Non-small Cell Lung Cancer Subgroup Analysis of the Lung Adjuvant Cisplatin Evaluation
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DOI：
10.1097/jto.0b013e3181c814e7
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发表时间：
2010-02-01
影响因子：
20.4
通讯作者：
Pignon, Jean Pierre
中科院分区：
文献类型：
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作者：
Douillard, Jean-Yves;Tribodet, Helene;Pignon, Jean Pierre
背景：旨在评估辅助顺铂-长春瑞滨对完全切除的非小细胞肺癌的影响，并在肺辅助顺铂评估（LACE）数据库中确定可能受益于该方案的患者。总体 LACE 荟萃分析显示，基于顺铂的辅助化疗具有生存获益（5 年生存获益为 5.4%，风险比 [HR] 0.89，p = 0.004）。 LACE 统计分析计划预先规定了顺铂-长春瑞滨方案的亚组分析。随机接受顺铂-长春瑞滨或观察组的患者是最大的亚组 (41%)，在药物剂量和资格方面也是最同质的。 患者和方法：LACE-长春瑞滨队列包括评估顺铂-长春瑞滨与观察组的试验。总生存期是主要终点。还评估了将患者随机分配至其他化疗或观察（LACE-其他）的其他研究。结果：LACE-长春瑞滨队列包括来自四项研究（长春瑞宾辅助试验协会、大肺试验、国际辅助肺癌试验和加拿大国家癌症研究所临床试验组 JBR.10）的 1888 名患者。基线特征与 LACE-other 相似，但 IA 期患者较少（2% 对 11%）。与观察相比，顺铂-长春瑞滨的 5 年生存率提高了 8.9%（HR 0.80，95% 置信区间：0.70-0.91，p
Background: To evaluate the impact of adjuvant cisplatin-vinorelbine in completely resected non-small cell lung cancer and identify patients likely to benefit from this regimen in the Lung Adjuvant Cisplatin Evaluation (LACE) database. The overall LACE meta-analysis showed survival benefit with cisplatin-based adjuvant chemotherapy (5-year survival benefit of 5.4%, hazard ratio [HR] 0.89, p = 0.004). Subgroup analysis for the cisplatin-vinorelbine regimen was prespecified in the LACE statistical analysis plan. Patients randomized to cisplatin-vinorelbine or observation were the largest subgroup (41%) and the most homogeneous in terms of drug doses and eligibility.Patients and Methods: The LACE-vinorelbine cohort included trials evaluating cisplatin-vinorelbine versus observation. Overall survival was the primary end point. Other studies randomizing patients to other chemotherapy or observation (LACE-other) were also evaluated.Results: The LACE-vinorelbine cohort included 1888 patients from four studies (Adjuvant Navelbine International Trialist Association, Big Lung Trial, International Adjuvant Lung Cancer Trial, and National Cancer Institute of Canada Clinical Trials Group JBR.10). Baseline characteristics were similar to the LACE-other but had fewer patients with stage IA (2% versus 11%). Survival improvement at 5 years was 8.9% with cisplatin-vinorelbine versus observation (HR 0.80, 95% confidence interval: 0.70-0.91, p