Adapted ECHO-7 virus Rigvir immunotherapy (oncolytic virotherapy) prolongs survival in melanoma patients after surgical excision of the tumour in a retrospective study.
Adapted ECHO-7 virus Rigvir immunotherapy (oncolytic virotherapy) prolongs survival in melanoma patients after surgical excision of the tumour in a retrospective study.
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在一项回顾性研究中，改良的 ECHO-7 病毒 Rigvir 免疫疗法（溶瘤病毒疗法）可延长黑色素瘤患者手术切除肿瘤后的生存期。
DOI：
10.1097/cmr.0000000000000180
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发表时间：
2015-10
影响因子：
2.2
通讯作者：
Muceniece A
中科院分区：
文献类型：
--
作者：
Doniņa S;Strēle I;Proboka G;Auziņš J;Alberts P;Jonsson B;Venskus D;Muceniece A
自 2004 年以来，一种适用于黑色素瘤的溶瘤非致病性 ECHO-7 病毒 (Rigvir) 已于 2004 年在拉脱维亚获得批准并注册用于病毒疗法，这是一种主动且特异性的免疫疗法。本回顾性研究的目的是确定 Rigvir 对 IB、IIA、IIB 和 IIC 期黑色素瘤患者的进展时间和总生存期的有效性。本研究包括接受原发性黑色素瘤手术切除的白人患者 (N=79)。所有患者术后均无疾病，分为IB、IIA、IIB和IIC亚期。记录临床化学参数的循环水平。通过Cox回归分析生存率。与正在观察的患者相比（根据现行指南），Rigvir 显着（P<0.05）延长了手术后 IB-IIC 期黑色素瘤患者的生存期。接受观察的患者与接受 Rigvir 治疗的患者相比，其风险比存在统计学上的显着差异：所有患者的风险比为 6.27，IIA-IIB-IIC 亚期患者的风险比为 4.39，IIB-IIC 亚期患者的风险比为 6.57。两个治疗组之间的随访期没有统计学差异。这些结果表明，接受 Rigvir 治疗的患者的死亡率比观察组患者低 4.39–6.57 倍。在这项研究中，Rigvir 治疗没有出现不良副作用或中止。根据 NCI CTCAE 分级的不良事件安全性评估在 Rigvir 治疗的患者中没有显示任何高于 2 级的值。总之，Rigvir 显着延长了早期黑色素瘤患者的生存期，且没有任何副作用。
An oncolytic, nonpathogenic ECHO-7 virus adapted for melanoma that has not been genetically modified (Rigvir) is approved and registered for virotherapy, an active and specific immunotherapy, in Latvia since 2004. The present retrospective study was carried out to determine the effectiveness of Rigvir in substage IB, IIA, IIB and IIC melanoma patients on time to progression and overall survival. White patients (N=79) who had undergone surgical excision of the primary melanoma tumour were included in this study. All patients were free from disease after surgery and classified into substages IB, IIA, IIB and IIC. Circulating levels of clinical chemistry parameters were recorded. Survival was analysed by Cox regression. Rigvir significantly (P<0.05) prolonged survival in substage IB–IIC melanoma patients following surgery compared with patients who were under observation (according to current guidelines). The hazard ratio for patients under observation versus treated with Rigvir was statistically significantly different: hazard ratio 6.27 for all, 4.39 for substage IIA–IIB–IIC and 6.57 for substage IIB–IIC patients. The follow-up period was not statistically different between both treatment groups. These results indicate that the patients treated with Rigvir had a 4.39–6.57-fold lower mortality than those under observation. In this study, there was no untoward side effect or discontinuation of Rigvir treatment. Safety assessment of adverse events graded according to NCI CTCAE did not show any value above grade 2 in Rigvir-treated patients. In conclusion, Rigvir significantly prolongs survival in early-stage melanoma patients without any side effect.