Follow-up analysis of a randomized phase III immunotherapeutic clinical trial on melanoma.

Development of a melanoma-specific vaccine is of clinical necessity. Therefore, a phase III, randomized, double-blind trial was performed (June 1988-June 1991) to assess the clinical effectiveness of our vaccinia melanoma oncolysate (VMO) vaccine in stage III melanoma patients. Patient data were collected from 11 institutions, as well as from the Social Security Death Index and were analyzed from April through August 2008 for disease-free interval (DFI) and overall survival (OS). The median OS for patients who were administered the VMO vaccine was 7.71 years, compared to 7.95 years for patients administered the vaccinia virus vaccine (V) (p=0.70). The median DFI for the VMO group was six years, while the median DFI for the V group has not yet been reached. This analysis demonstrated a statistically significant difference in OS in females in both groups (VMO, 79%; V, 92%), as compared to males (VMO, 57%; V, 68%) (p=0.0473). This follow-up analysis demonstrated that females had a survival advantage over males, thus warranting further investigation. This significant observation may facilitate the recruitment of patients for future clinical trials, as well as determine which patients are more likely to benefit from receiving the VMO vaccine.