Overview analysis of adjuvant therapies for melanoma - a special referenceto results from vaccinia melanoma oncolysate therapy trials

A phase III, randomized, double-blind, multi-institutional vaccinia melanom a oncolysate (VMO) trial was performed for patients with stage III (AJCC) m elanoma. When compared with the control vaccinia virus (V) therapy, VMO the rapy did not show clinical efficacy in the final analysis of data from this trial. However, the data did allude to significant therapeutic efficacy wi th VMO therapy if it had been compared with an observation arm. Therefore, a comparative overview statistical analysis was performed to identify the t herapeutic efficacy of VMO. This review compares VMO results with data from the treatment and observation arms of other prominent randomized anti-mela noma biologic trials (i.e., FCOG EST 1684; SWOG, IFN-gamma (J. Natl. Cancer Inst. 87 (1995) 1710); WHO IFN-alfa-2a (ASCO 14 (1995) 410); Mayo IFN-alfa -2a (J. Clin. Oncol. 13 (1995) 2776); French IFN-alfa-2a (ASCO 15 (1996) 43 7). The analysis was carried out comparing the disease-free interval (DFI) and overall survival (OS). The analysis shows that the VMO results are fair ly comparable to the results of the treatment arms from the ECOG and Mayo t rials at the 5-year mark; percent DFI 0.37, 0.37, and 0.4, percent OS 0.48, 0.46, 0.47, respectively. In some cases, VMO DFI is superior to the observ ation arms from other studies; ECOG, Mayo, and WHO; 0.37 versus 0.26, 0.3, 0.27 (4 years), respectively. These comparative results suggest that the va ccinia arm is not a true observation arm in the VMO trial, and the VMO coul d have shown an enhanced efficacy had the trial included a no-treatment obs ervation control arm. (C) 2001 Elsevier Science Ltd. All rights reserved.