Survival benefit of oral UFT for adjuvant chemotherapy after completely resected non-small-cell lung cancer.
Survival benefit of oral UFT for adjuvant chemotherapy after completely resected non-small-cell lung cancer.
复制标题
完全切除非小细胞肺癌后口服 UFT 辅助化疗的生存获益。
DOI：
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发表时间：
2004
影响因子：
45.3
通讯作者：
N. Matsuoka
中科院分区：
文献类型：
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作者：
C. Hamada;M. Ohta;H. Wada;S. Fujimura;K. Kodama;M. Imaizumi;Y. Nakanishi;N. Matsuoka
背景：在评估非小细胞肺癌术后辅助化疗疗效的临床试验中，应将生存率作为主要终点。由于样本量有限，单一研究通常不能提供明确的结论。因此，我们对所有适当随机的临床试验进行了荟萃分析，比较了在完全切除的非小细胞肺癌患者中，长期辅助化疗联合UFT(一种口服氟化嘧啶)与单纯手术的疗效，并进行了一些亚组分析和相互作用测试，以评估药物效果的概括性。
方法
确定了六项这样的试验。这项分析是基于每个试验的首席调查员提供的个别患者数据。在意向治疗的基础上分析了2,003名符合条件的患者的数据。感兴趣的终点是术后5年的总存活率。UFT组和单纯手术组之间的主要预后因素很好地平衡。
结果
Meta分析结果显示，UFT辅助化疗可显著提高总生存率(5年OS，HR 0.77；95%CI，0.63~0.94；p=0.011，7年OS，HR，0.74；95%CI，0.61~0.88；p=0.001)。UFT组5年OS率为81.8%，7年OS率为76.5%；单纯手术组为77.2%，69.5%。
结论
我们的结论是，对于完全切除的早期非小细胞肺癌患者，术后辅助化疗联合UFT具有一致的有利效果。没有重大的财务关系需要披露。
7002 Background: Survival rate should be used as the primary endpoint in clinical trials assessing the response of non-small-cell lung cancer to postoperative adjuvant chemotherapy. Single studies usually do not provide clear-cut conclusions because of limited sample size. We therefore performed a meta-analysis of all properly randomized clinical trials comparing long-term adjuvant chemotherapy with UFT, an oral fluorinated pyrimidine, to surgery alone in patients with completely resected non-small-cell lung cancer, and a number of subgroup analyses and tests for interaction were performed to evaluate generalizability of drug effect.
METHODS
Six such trials were identified. The analysis was based on individual patient data provided by the principal investigator of each trial. Data from 2,003 eligible patients were analyzed on an intention-to-treat basis. The endpoint of interest was overall survival at 5 years after surgery. Major prognostic factors were well balanced between the UFT group and surgery alone group.
RESULTS
The results of meta-analysis demonstrated that adjuvant chemotherapy with UFT significantly improved overall survival (5-year OS, HR, 0.77; 95%CI, 0.63-0.94; p=0.011, 7-year OS, HR, 0.74; 95%CI, 0.61-0.88; p=0.001). The 5-year OS rates and 7-year OS rates were 81.8%, 76.5% for the UFT arm and 77.2%, 69.5% for the surgery alone arm.
CONCLUSIONS
We conclude that postoperative adjuvant chemotherapy with UFT has a beneficial effect uniformly in patients with completely resected early-stage non-small-cell lung cancer. No significant financial relationships to disclose.