Lipton A, Harvey H A, Balch C M, Antle C E, Heckard R, Bartolucci A A
Department of Medicine, Milton S. Hershey Medical Center, Hershey, PA 17033.
J Clin Oncol. 1991 Jul;9(7):1151-6. doi: 10.1200/JCO.1991.9.7.1151.
Two separate studies have been reported comparing Corynebacterium parvum and bacille Calmette-Guérin (BCG) as adjuvant immunotherapy for stage II melanoma patients (The Milton S. Hershey Medical Center, 48 patients; Southeastern Cancer Study Group [SECSG], 162 patients). As the criteria for patient selection and drugs used were similar, we have pooled the data to analyze the effects of these two treatments. Both studies used BCG (Tice, Chicago, IL) 3 x 10(8) live organisms per treatment by Tine technique and C parvum (Burroughs-Wellcome, Triangle Park, NC) subcutaneous at a dose of 4 mg/m2 (SECSG) or 5 micrograms/m2 (Hershey) per treatment. The only difference in these studies was the frequency of immunization, with patients in Hershey receiving 22 doses and the SECSG patients receiving 55 doses during the 2-year period of treatment. Kaplan-Meier life-table analysis for the 210 patients shows a prolonged disease-free interval for patients treated with C parvum (P = .02, two-sided Mantel procedure). In similar fashion, patients treated with C parvum had an improved survival rate (from all causes) when compared with BCG-treated patients (P = .012). An analysis of the results for the 170 patients for which the number of positive nodes was available was performed using Cox's model, with nodes as a stratification variable and with covariates of place, treatment, age, and sex. In this analysis, an observed benefit for C parvum on the disease-free interval had a P value of .37 while the benefit of C parvum on the survival times (from all causes) had a P value of .04. When the same analysis was performed using only patients aged younger than 60 years, the observed benefit of C parvum on disease-free interval had a P value of .08 and the benefit of C parvum on survival times (from all causes) had a P value of .008.
已有两项独立研究报告了比较微小棒状杆菌和卡介苗（BCG）作为II期黑色素瘤患者辅助免疫疗法的情况（米尔顿·S·赫尔希医疗中心，48例患者；东南癌症研究组[SECSG]，162例患者）。由于患者选择标准和所用药物相似，我们汇总了数据以分析这两种治疗方法的效果。两项研究均使用卡介苗（蒂氏，伊利诺伊州芝加哥），每次治疗采用划痕法接种3×10⁸活菌体，以及微小棒状杆菌（百时美施贵宝公司，北卡罗来纳州三角研究园），皮下注射，每次剂量为4mg/m²（SECSG）或5μg/m²（赫尔希）。这些研究的唯一差异在于免疫接种频率，在2年的治疗期内，赫尔希的患者接受22次接种，而SECSG的患者接受55次接种。对这210例患者进行的Kaplan-Meier生存表分析显示，接受微小棒状杆菌治疗的患者无病间期延长（P = 0.02，双侧Mantel检验）。同样，与接受卡介苗治疗的患者相比，接受微小棒状杆菌治疗的患者（所有原因导致的）生存率有所提高（P = 0.012）。对170例有阳性淋巴结数量数据的患者结果进行分析时，使用Cox模型，将淋巴结作为分层变量，并将地点、治疗、年龄和性别作为协变量。在此分析中，微小棒状杆菌对无病间期的观察到的益处P值为0.37，而微小棒状杆菌对生存时间（所有原因导致的）的益处P值为0.04。当仅对60岁以下的患者进行相同分析时，微小棒状杆菌对无病间期的观察到的益处P值为0.08，而微小棒状杆菌对生存时间（所有原因导致的）的益处P值为0.008。
