Hsueh E C, Gupta R K, Qi K, Yee R, Leopoldo Z C, Morton D L
Roy E. Coats Research Laboratories, John Wayne Cancer Institute, Saint John's Health Center, Santa Monica, California, USA.
Cancer J Sci Am. 1997 Nov-Dec;3(6):364-70.
Although prognosis remains poor for patients with distant metastatic melanoma, we have observed significantly prolonged survival in patients receiving our polyvalent melanoma cell vaccine (PMCV) following complete metastasectomy for American Joint Committee on Cancer (AJCC) stage IV melanoma. Clinical prognostic factors specific to this stage IV subgroup have not been well characterized. We previously reported that the serum immune complex (IC) level of a 90-kD glycoprotein antigen (TA90) was an objective predictor of survival and recurrence in patients with early-stage melanoma. In the present study we correlated the postoperative TA90-IC level of AJCC stage IV patients prior to adjuvant PMCV therapy with their duration of subsequent survival.
From October 1, 1984, to December 31, 1995, 125 stage IV patients began PMCV after complete resection of distant melanoma metastases. One blood sample was obtained immediately prior to vaccine therapy, and the serum TA90-IC level was assessed as positive or negative using our double-determinant ELISA. Disease-free and overall survival were recorded prospectively from the start of vaccine therapy. The correlation between prevaccine TA90-IC level and survival was assessed by the log-rank test and Cox proportional hazards model.
Median follow-up after PMCV therapy was 36.5 months, with a minimum of 12 months. Univariate analysis demonstrated that TA90-IC level is significant for both overall survival and disease-free survival. Median overall survival, median disease-free survival, and rate of 5-year survival were higher for patients with negative TA90-IC levels than for those with positive TA90-IC level (58 vs 19 months, 7 vs 4 months, and 49% vs 27%, respectively). Multivariate analysis established TA90-IC as an independent prognostic indicator for both overall and disease-free survival following adjuvant PMCV therapy for AJCC stage IV melanoma.
Prevaccine TA90-IC level correlated strongly with overall and disease-free survival in our stage IV melanoma patients receiving postoperative PMCV immunotherapy. This is the first serum marker shown to have importance in predicting the survival of melanoma patients receiving adjuvant immunotherapy after complete resection of distant metastases.
尽管远处转移性黑色素瘤患者的预后仍然很差，但我们观察到，对于接受美国癌症联合委员会（AJCC）IV期黑色素瘤完全转移灶切除术后接受我们的多价黑色素瘤细胞疫苗（PMCV）治疗的患者，其生存期显著延长。这一IV期亚组特有的临床预后因素尚未得到很好的描述。我们之前报道，一种90-kD糖蛋白抗原（TA90）的血清免疫复合物（IC）水平是早期黑色素瘤患者生存和复发的客观预测指标。在本研究中，我们将AJCC IV期患者在辅助PMCV治疗前的术后TA90-IC水平与其随后的生存期进行了关联分析。
从1984年10月1日至1995年12月31日，125例IV期患者在远处黑色素瘤转移灶完全切除后开始接受PMCV治疗。在疫苗治疗前立即采集一份血样，使用我们的双检测酶联免疫吸附测定法（ELISA）将血清TA90-IC水平评估为阳性或阴性。从疫苗治疗开始前瞻性记录无病生存期和总生存期。通过对数秩检验和Cox比例风险模型评估疫苗接种前TA90-IC水平与生存期之间的相关性。
PMCV治疗后的中位随访时间为36.5个月，最短为12个月。单因素分析表明，TA90-IC水平对总生存期和无病生存期均具有显著意义。TA90-IC水平为阴性的患者的中位总生存期、中位无病生存期和5年生存率均高于TA90-IC水平为阳性的患者（分别为58个月对19个月、7个月对4个月、49%对27%）。多因素分析确定TA90-IC是AJCC IV期黑色素瘤辅助PMCV治疗后总生存期和无病生存期的独立预后指标。
在我们接受术后PMCV免疫治疗的IV期黑色素瘤患者中，疫苗接种前TA90-IC水平与总生存期和无病生存期密切相关。这是首个被证明对远处转移灶完全切除后接受辅助免疫治疗的黑色素瘤患者的生存具有预测重要性的血清标志物。
