Skin tests predict survival after autologous tumor cell vaccination in metastatic melanoma: Experience in 81 patients

Skin tests predict survival after autologous tumor cell vaccination in metastatic melanoma: Experience in 81 patients
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DOI:
10.1023/a:1008363601515
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发表时间:
2000-08-01
期刊:
影响因子:
50.5
通讯作者:
Pinedo, HM
Pinedo, HM
中科院分区:
医学1区
文献类型:
--
作者:
Baars, A;Claessen, AME;Pinedo, HM

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背景:目前,转移性黑色素瘤手术切除后尚无标准的辅助治疗方法。我们调查了手术后接种自体肿瘤细胞-卡介苗是否对恶性黑色素瘤患者有利。在这项研究中,我们关注接种疫苗治疗后DTH反应的预后价值。患者和方法:选择81例AJCC III和IV期黑色素瘤患者。只要可行,就行根治性转移瘤切除术。ASI是通过每周三次皮内接种10(7)照射的自体肿瘤细胞开始的,从手术后四周开始。根据对前三次注射的DTH反应的大小,计划随后的疫苗接种。前两种疫苗还含有10(7)种卡介苗作为免疫刺激佐剂。结果:硬结和红斑与存活率密切相关(P<0.0001和P=0.0004)。在III期黑色素瘤患者的根治性转移切除后,观察到48%的五年存活率。在IV期疾病中,根治性手术后的五年存活率为34%。当接种治疗开始时出现肉眼疾病时,没有出现临床反应。除接种部位出现一过性皮肤溃疡外,未观察到严重的副作用。结论:本研究表明,大规模制备自体黑色素瘤细胞疫苗是可行的,而接种可产生与生存显著相关的迟发型超敏反应。在辅助剂环境下给予ASI似乎对III期和IV期黑色素瘤有益,同时只引起非常轻微的副作用。
Background: Currently there is no standard adjuvant treatment following surgical resection of metastatic melanoma. We investigated whether surgery followed by autologous tumor cell-BCG vaccination was beneficial for malignant melanoma patients. In this study we focus on the prognostic value of DTH response following vaccination therapy.Patients and methods: Eighty-one patients with AJCC stage III and IV melanoma were selected. Whenever feasible, radical metastasectomy was performed. ASI was initiated by the administration of three weekly intra-cutaneous vaccinations with 10(7) irradiated autologous tumor cells, starting four weeks after surgery. Depending on the size of DTH response to the first three injections, subsequent vaccinations were planned. The first two vaccines also contained 10(7) BCG organisms as an immune stimulatory adjuvant.Results: Induration as well as erythema correlated strongly with survival (P < 0.0001 and P = 0.0004). After radical metastasectomy in stage III melanoma patients a five-year survival of 48% was observed. In stage IV disease, a five-year survival of 34% was seen, after radical surgery had been performed. When macroscopic disease was present at start of vaccination treatment, no clinical responses occurred. Apart from transient skin ulceration at the site of BCG-containing vaccinations, no serious side effects were observed.Conclusions: This study shows that large-scale preparation of autologous melanoma cell vaccines is feasible, while vaccination results in DTH responses that correlate significantly with survival. ASI seemed to be beneficial in stage III and stage IV melanoma when given in the adjuvant setting, while causing only very mild side effects.