Ten-year analysis of vaccinia melanoma oncolysate (VMO) phase III trial.

e19031 Background: We present a 10-year analysis of the first randomized, prospective, double-blind, multi- institutional melanoma vaccine trial with patients treated with either vaccinia melanoma oncolysate (VMO) or attenuated vaccinia virus (VV) between June 1988 and June 1991. Methods: Patient data was collected from eleven institutions over the course of trial, as well as from the Social Security Death Index. This data was analyzed in April 2008 for disease-free interval (DFI) and overall survival (OS) using log-rank analysis. Results: At time of analysis, 109 patients were evaluable with 78 patients living (35 VMO, 43 VV). The patients were divided as such: VMO_Alive, VV_Alive, VMO_Deceased, VV_Deceased. Gender-wise, 79% of females treated with VMO have survived, compared to 52% of males (p = 0.0473). There was no statistical significance among VMO- and VV-treated groups with reference to age (p = 0.3286), number of nodes (p = 0.6855), time (p = 0.5525), or size of lesion (p = 0.4008). Conclusions: T...