Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group study E5283
Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group study E5283
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DOI：
10.1200/jco.2000.18.1.148
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发表时间：
2000-01-01
影响因子：
45.3
通讯作者：
Hanna, MG
中科院分区：
文献类型：
--
作者：
Harris, JE;Ryan, L;Hanna, MG
目的：一项随机III期临床试验，用自体肿瘤细胞卡介苗（BCG）疫苗进行辅助活性特异性免疫治疗（ASI），以确定手术切除加ASI是否比II期和III期结肠癌患者单独切除更有益。患者和方法：结肠癌患者（n = 412）（297例II期疾病，115例III期疾病患者）随机分配到观察组或治疗组，其中他们每周接受三次皮内疫苗注射，每次10（7）在手术后约4周开始照射自体肿瘤细胞。前两次每周注射也含有10（7）个BCG微生物。观察患者的复发时间和无病生存和总survival.Results的确定：这是一个负面的研究，在7.6年的中位数随访期后，有治疗组之间的临床结果没有统计学上的显着差异。然而，当评估治疗依从性时，ASI的无病生存率（P = 0.078）和总生存率（P = 0.12）趋势，即接受预期治疗的患者对第三次接种有迟发性皮肤超敏反应（DCH）反应（硬结大于或等于5 mm）。此外，DCH反应的程度与预后改善相关。硬结大于10 mm的患者的5年生存率为84.6%，而硬结小于5 mm的患者的5年生存率为45.0%。结论：当评估所有随机患者时，在手术切除的II期或III期结肠癌患者中，未观察到ASI的显着临床益处。然而，有迹象表明，治疗依从性与有效的免疫接种导致无病和总体生存的好处。(C)2000年，美国临床肿瘤学会。
Purpose: A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell-bacillus Calmette-Guerin (BCG) vaccine wets conducted to determine whether surgical resection plus ASI was more beneficial than resection alone in stage II and III colon cancer patients.Patients and Methods: Patients(n = 412) with colon cancer (297 with stage II disease, 115 with stage III disease) were randomly allocated to an observation arm or to a treatment arm in which they received three weekly intradermal vaccine injections of 10(7) irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 10(7) BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival.Results: This was a negative study in that after a 7.6-year median follow-up period, there were no statistically significant differences in clinical outcomes between the treatment arms. However, there were disease-free survival (P = .078) and overall survival (P = .12) trends in fervor of ASI when treatment compliance was evaluated, ie, patients who received the intended treatment had a delayed cutaneous hypersensitivity (DCH) response to the third vaccination (induration greater than or equal to 5 mm). Also, the magnitude of the DCH response correlated with improved prognosis. The 5-year survival proportion was 84.6% for those with indurations greater than 10 mm, compared with 45.0% for those with indurations less than 5 mm.Conclusions: When all randomized patients were evaluated, no significant clinical benefit was seen with ASI in surgically resected colon cancer patients with stage II or III colon cancer. However, there was an indication that treatment compliance with effective immunization results in disease-free and overall survival benefits. (C) 2000 by American Society of Clinical Oncology.