Adjuvant active specific immunotherapy of stage II and stage III colon cancer with an autologous tumor cell vaccine: first randomized phase III trials show promise
Adjuvant active specific immunotherapy of stage II and stage III colon cancer with an autologous tumor cell vaccine: first randomized phase III trials show promise
复制标题
DOI：
10.1016/s0264-410x(00)00485-0
复制
发表时间：
2001-03-21
期刊：
影响因子：
5.5
通讯作者：
Pinedo, HM
中科院分区：
文献类型：
--
作者：
Hanna, MG;Hoover, HC;Pinedo, HM
我们进行了三项多机构，前瞻性随机对照临床试验，评估切除术后辅助活性特异性免疫治疗对II期和III期结肠癌患者的治疗效果。在每项研究中，考虑了四个结果：疾病复发时间，总生存期，无病生存期。使用Kaplan-Meir方法生成曲线，使用对数秩检验比较疗效分布，计算无复发生存期。此外，对三项III期试验进行了荟萃分析，因为这些试验已证明具有同质性。进行了两项主要分析：（1）所有三项研究中的意向治疗结肠癌患者，以及（2）所有三项研究中的可分析结肠癌患者。这些分析的结论是，辅助主动特异性免疫治疗为II期结肠癌患者提供了显着的临床获益，似乎是这些患者的一种重要的新辅助治疗。(C)2001爱思唯尔科技有限公司版权所有。
We performed three multi-institutional, prospectively randomized, controlled clinical trials, assessing the therapeutic effect of post-resection adjuvant active specific immunotherapy in patients with stage II and stage III colon cancer. In each study four outcomes were considered: time-to-disease recurrence, overall survival intervals, disease-free survival intervals. and recurrence-free survival intervals using the Kaplan-Meir method for generating curves and the log-rank test used to compare efficacy distributions. In addition, a meta-analysis of the three phase III trials was performed since the trials had proven homogeneity. Two main analyses were performed: (1) the intent-to-treat colon cancer patients from all three studies, and (2) analyzable colon cancer patients in all three studies. The conclusion of these analyses is that adjuvant active specific immunotherapy provided significant clinical benefits in patients with stage II colon cancer and appears to be an important new adjuvant treatment for these patients. (C) 2001 Elsevier Science Ltd. All rights reserved.