新城疫病毒修饰的肿瘤细胞辅助主动特异性免疫疗法对结直肠癌肝转移切除术后患者的疗效：一项前瞻性随机试验的结果
Efficiency of adjuvant active specific immunization with Newcastle disease virus modified tumor cells in colorectal cancer patients following resection of liver metastases: results of a prospective randomized trial.
作者信息
Schulze T, Kemmner W, Weitz J, Wernecke K-D, Schirrmacher V, Schlag P M
机构信息
Department of Surgery and Surgical Oncology, Robert-Rössle-Klinik Berlin, Charité, Campus Buch, Universitätsmedizin Berlin, Klinik für Chirurgie und Chirurgische Onkologie, Berlin, Germany.
出版信息
Cancer Immunol Immunother. 2009 Jan;58(1):61-9. doi: 10.1007/s00262-008-0526-1. Epub 2008 May 17.
PURPOSE
Metastatic disease is a major cause of mortality in colorectal cancer patients. Even after complete resection of isolated liver metastases, recurrence develops in the majority of patients. Therefore, development of strategies to prevent recurrent liver metastases is of major clinical importance. The present prospectively randomised phase III trial investigates the efficiency of active specific immunotherapy (ASI) after liver resection for hepatic metastases of colorectal cancer.
METHODS
Patients with histologically confirmed liver metastases from colorectal cancer were randomised to the vaccination or control group. After complete resection of liver metastases, patients randomised to the vaccination group received six doses of Newcastle disease virus (NDV) infected autologous tumour cell vaccine (ATV-NDV). The primary end-point was overall survival, secondary end-points were disease-free survival and metastases-free survival.
RESULTS
Fifty-one patients were enrolled in the study with 50 patients available for analysis. The follow-up period was 116.1 +/- 23.8 month in the vaccination arm and 112.4 +/- 18.5 month in the control group. In the total patient group, no differences in the primary and secondary end-points were detected. Most interestingly, subgroup analysis revealed a significant advantage for vaccinated colon cancer patients with respect to overall survival [hazard ratio: 3.3; 95%, confidence interval (CI): 1.0-10.4; P = 0.042] and metastases-free survival (hazard ratio: 2.7; 95%, CI: 1.0-7.4; P = 0.047) in the intention-to-treat analysis.
CONCLUSION
Active specific immunotherapy in unselected colorectal cancer patients was not effective for prevention of recurrent metastatic disease. However, in colon cancer patients, ASI with ATV-NDV appears to be beneficial prolonging overall and metastases-free survival.
目的
转移性疾病是结直肠癌患者死亡的主要原因。即使孤立性肝转移灶完全切除后，大多数患者仍会复发。因此，制定预防复发性肝转移的策略具有重要的临床意义。本前瞻性随机III期试验研究了结直肠癌肝转移灶切除术后主动特异性免疫治疗（ASI）的疗效。
方法
组织学确诊为结直肠癌肝转移的患者被随机分为疫苗接种组或对照组。肝转移灶完全切除后，随机分配到疫苗接种组的患者接受六剂新城疫病毒（NDV）感染的自体肿瘤细胞疫苗（ATV-NDV）。主要终点是总生存期，次要终点是无病生存期和无转移生存期。
结果
51例患者入组本研究，50例患者可供分析。疫苗接种组的随访期为116.1±23.8个月，对照组为112.4±18.5个月。在整个患者组中，未检测到主要和次要终点的差异。最有趣的是，亚组分析显示，在意向性分析中，接种疫苗的结肠癌患者在总生存期[风险比：3.3；95%，置信区间（CI）：1.0-10.4；P = 0.042]和无转移生存期（风险比：2.7；95%，CI：1.0-7.4；P = 0.047）方面具有显著优势。
结论
对未选择的结直肠癌患者进行主动特异性免疫治疗对预防复发性转移性疾病无效。然而，在结肠癌患者中，使用ATV-NDV进行ASI似乎有利于延长总生存期和无转移生存期。
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