Wallack M K, Sivanandham M, Whooley B, Ditaranto K, Bartolucci A A
St. Vincent's Hospital, Department of Surgery, New York, NY, USA.
Ann Surg Oncol. 1996 Mar;3(2):110-7. doi: 10.1007/BF02305788.
A phase III, randomized, double-blind, multi-institutional trial was performed evaluating active specific immunotherapy using vaccinia melanoma oncolysate (VMO) in the surgical adjuvant setting in patients with stage II melanoma (UICC staging). The first interim analysis showed no significant difference in disease-free and overall survival. The data were further analyzed to identify subsets of patients with improved outcome when treated with VMO.
Patients received either VMO or placebo of live vaccinia vaccine virus (V), once a week for 13 weeks and then once every 2 weeks for an additional 39 weeks or until recurrence. Having stratified patients according to sex, age, number of positive nodes, tumor thickness, and clinical stage, data were analyzed for disease-free survival and overall survival.
Male patients showed a 17% difference in overall survival at 4 years when treated with VMO (p = 0.19). A subset of male patients < 57 years of age with one to five positive nodes showed a 30% difference at 4 years with VMO (p = 0.06). Patients with clinical stage I but pathological stage II disease (both male and female), who had undergone prophylactic node dissection, showed a 23% difference in survival at 3 years with VMO (p = 0.11).
This subset analysis shows encouraging survival benefit in certain subsets of patients and an increasing trend in overall survival. Further follow-up of this phase III trial from a second interim analysis will be forthcoming.
开展了一项III期随机双盲多机构试验，评估在II期黑色素瘤（国际抗癌联盟分期）患者的手术辅助治疗中使用牛痘黑色素瘤溶瘤物（VMO）进行主动特异性免疫治疗的效果。首次中期分析显示无病生存期和总生存期无显著差异。对数据进行进一步分析，以确定接受VMO治疗后预后改善的患者亚组。
患者接受VMO或活牛痘疫苗病毒（V）安慰剂治疗，每周一次，共13周，然后每2周一次，再持续39周或直至复发。根据性别、年龄、阳性淋巴结数量、肿瘤厚度和临床分期对患者进行分层后，分析无病生存期和总生存期数据。
接受VMO治疗的男性患者4年总生存期差异为17%（p = 0.19）。年龄<57岁、有1至5个阳性淋巴结的男性患者亚组，接受VMO治疗4年时差异为30%（p = 0.06）。临床分期为I期但病理分期为II期（无论男女）且接受过预防性淋巴结清扫的患者，接受VMO治疗3年时生存差异为23%（p = 0.11）。
该亚组分析显示在某些患者亚组中生存获益令人鼓舞，且总生存期呈上升趋势。将对该III期试验进行第二次中期分析并进行进一步随访。
