完全切除的非小细胞肺癌的辅助顺铂和长春瑞滨：肺辅助顺铂评估的亚组分析。

Adjuvant cisplatin and vinorelbine for completely resected non-small cell lung cancer: subgroup analysis of the Lung Adjuvant Cisplatin Evaluation.

机构信息

Department of Medical Oncology, Centre R Gauducheau, St-Herblain, France.

出版信息

J Thorac Oncol. 2010 Feb;5(2):220-8. doi: 10.1097/JTO.0b013e3181c814e7.

DOI:10.1097/JTO.0b013e3181c814e7

PMID:20027124

Abstract

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 <0.001). Stage was a significant predictor for survival (test for trend, p = 0.02; benefit at 5 years: 14.7% [stage III], 11.6% [stage II], and 1.8% [stage I]). Similar benefits were seen for disease-free survival (HR 0.75 [0.67-0.85, p <0.001], stage III [HR 0.62, 0.50-0.76], stage II [HR 0.69, 0.57-0.83], and stage I [HR 0.95, 0.767-1.19]). The overall result was statistically superior to LACE-other (LACE other HR 0.95, 0.86-1.05, interaction p = 0.04).

CONCLUSION

In subgroup analyses, adjuvant cisplatin-vinorelbine provides a superior survival benefit and can be recommended in completely resected stages II and III non-small cell lung cancer.

摘要

背景

为了评估辅助顺铂-长春瑞滨在完全切除的非小细胞肺癌中的影响，并在 Lung Adjuvant Cisplatin Evaluation (LACE) 数据库中确定可能从该方案中获益的患者。总体 LACE 荟萃分析显示，基于顺铂的辅助化疗有生存获益（5 年生存率获益 5.4%，风险比[HR]0.89，p=0.004）。LACE 统计分析计划中预设了顺铂-长春瑞滨方案的亚组分析。接受顺铂-长春瑞滨或观察治疗的患者是最大的亚组（41%），并且在药物剂量和纳入标准方面最为同质。

患者和方法

LACE-vinorelbine 队列纳入了评估顺铂-长春瑞滨与观察的试验。总生存期是主要终点。还评估了其他将患者随机分配至其他化疗或观察的研究（LACE-other）。

结果

LACE-vinorelbine 队列纳入了来自四项研究（Adjuvant Navelbine International Trialist Association、Big Lung Trial、International Adjuvant Lung Cancer Trial 和 National Cancer Institute of Canada Clinical Trials Group JBR.10）的 1888 例患者。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-长春瑞滨治疗 5 年时的生存改善为 8.9%（HR 0.80，95%置信区间：0.70-0.91，p<0.001）。分期是生存的显著预测因素（趋势检验，p=0.02；5 年获益：III 期 14.7%，II 期 11.6%，I 期 1.8%）。无病生存期也有类似的获益（HR 0.75[0.67-0.85，p<0.001]，III 期[HR 0.62，0.50-0.76]，II 期[HR 0.69，0.57-0.83]，I 期[HR 0.95，0.767-1.19]）。总体结果明显优于 LACE-other（LACE other HR 0.95，0.86-1.05，交互检验 p=0.04）。