title: Adapted ECHO-7 virus Rigvir immunotherapy (oncolytic virotherapy) prolongs survival in melanoma patients after surgical excision of the tumour in a retrospective study.
abstract: 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.
authors.affiliation: aOutpatient Department, Riga Eastern Clinical University Hospital bInstitute of Microbiology and Virology cDepartment of Public Health and Epidemiology, Riga Stradiņš University dLatvian Virotherapy Center, Riga, Latvia eDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
authors.forename: Simona
authors.initials: S
authors.lastname: Doniņa
authors.forename: Ieva
authors.initials: I
authors.lastname: Strēle
authors.forename: Guna
authors.initials: G
authors.lastname: Proboka
authors.forename: Jurgis
authors.initials: J
authors.lastname: Auziņš
authors.forename: Pēteris
authors.initials: P
authors.lastname: Alberts
authors.forename: Björn
authors.initials: B
authors.lastname: Jonsson
authors.forename: Dite
authors.initials: D
authors.lastname: Venskus
authors.forename: Aina
authors.initials: A
authors.lastname: Muceniece
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D029822:Enterovirus B, Human / Q000276:immunology; D005260:Female; D006801:Humans; D007844:Latvia / Q000453:epidemiology; D008297:Male; D008545:Melanoma / Q000401:mortality* / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D008875:Middle Aged; D009367:Neoplasm Staging; D050130:Oncolytic Virotherapy / Q000379:methods*; D011184:Postoperative Period; D012189:Retrospective Studies; D012878:Skin Neoplasms / Q000401:mortality* / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D016019:Survival Analysis; D055815:Young Adult