Hersey P
Department of Oncology and Immunology, Royal Newcastle Hospital, Newcastle, New South Wales, Australia.
World J Surg. 1992 Mar-Apr;16(2):251-60. doi: 10.1007/BF02071529.
Patients who develop lymph node metastases from melanoma are known to be at risk of developing further recurrences from melanoma following surgical removal of lymph node metastases. The purpose of the present study was to examine whether immunization over a 2 year period with a vaccine made from vaccinia viral lysates of an allogeneic melanoma cell (VMCL), following surgical removal of lymph node metastases, would help prevent the development of distant metastases and improve survival from the disease. Eighty patients treated with VMCL alone and followed for a minimum of 5.5 years had improved survival compared to a historical control group of 151 patients and a concurrent non-randomized group of 55 patients. Similarly, the survival of 102 patients treated with VMCL + low dose cyclophosphamide for a minimum of 3.5 years was superior to that of the historical control group but not to that of the VMCL alone treated group. Improvement in survival was still evident when this was measured from the date of removal of the primary tumor. Analysis of subsets of patients showed that VMCL treatment appeared to benefit patients irrespective of the number of lymph nodes involved and whether surgery was carried out near to (synchronous metastases) or some time after removal of the primary (delayed metastases). Analysis of the effect of treatment on duration to development of distant metastases suggested that there was a lower proportion of metastases during treatment with VMCL compared to the historical control groups. Treatment with VMCL also appeared to be associated with a lower incidence of cutaneous metastases but a higher proportion of visceral (including liver) metastases. Treatment was not associated with prolongation of survival after development of distant metastases. The results from this prolonged follow-up provide further support for an apparent survival benefit from immunotherapy with VMCL and suggest that the duration to and site of distant metastases is altered by this treatment. A randomized control (Phase III) study based on these results is in progress.
已知发生黑色素瘤淋巴结转移的患者在手术切除淋巴结转移灶后有发生黑色素瘤进一步复发的风险。本研究的目的是探讨在手术切除淋巴结转移灶后，用同种异体黑色素瘤细胞痘苗病毒裂解物制成的疫苗进行为期2年的免疫接种，是否有助于预防远处转移的发生并提高该疾病的生存率。与151例历史对照组患者和55例同期非随机分组患者相比，单独接受VMCL治疗并至少随访5.5年的80例患者生存率有所提高。同样，102例接受VMCL + 低剂量环磷酰胺治疗至少3.5年的患者的生存率优于历史对照组，但不如单独接受VMCL治疗的组。从原发肿瘤切除日期开始测量生存率时，生存率的提高仍然很明显。对患者亚组的分析表明，无论受累淋巴结的数量以及手术是在切除原发肿瘤时（同步转移）还是在切除原发肿瘤后的一段时间（延迟转移）进行，VMCL治疗似乎都对患者有益。对治疗对远处转移发生时间的影响分析表明，与历史对照组相比，VMCL治疗期间转移的比例较低。VMCL治疗还似乎与皮肤转移的发生率较低但内脏（包括肝脏）转移的比例较高有关。远处转移发生后，治疗与生存期延长无关。这种长期随访的结果为VMCL免疫治疗明显的生存获益提供了进一步支持，并表明这种治疗改变了远处转移的发生时间和部位。基于这些结果的随机对照（III期）研究正在进行中。
