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Adjuvant immunotherapy using vaccinia viral lysates found ineffective.
2003 JAN 1 - (NewsRx.com & NewsRx.net) -- Phase III study results show immunotherapy with vaccinia viral lysates doesn't benefit patients with high-risk melanoma.
The "prospective, randomized, multicenter trial [aimed] to determine whether immunotherapy with a vaccine prepared from vaccinia melanoma cell lysates (VMCL) over a 2-year period after definitive surgery would improve relapse-free survival (RFS) and overall survival (OS) in patients with American Joint Committee on Cancer stage IIIB and III melanoma compared with a control group treated only with surgery," wrote P. Hersey and colleagues.
In the study, 353 patients were randomized to VMCL and 347 received no immunotherapy. "Seventy-seven percent had lymph node (LN) metastases and 66% had clinically detected LN metastases," the researchers said.
"Analysis on the basis of all eligible, randomized patients (n=675) found, after a median follow-up period of 8 years, a median OS of 88 months in the control versus 151 months in the treated group (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.64 to 1.02; p=068 by stratified univariate Cox analysis)," reported Hersey's group.
"At 5 and 10 years, survival rates for control and treated patients were 54.8% versus 60.6% and 41% v 53.4%, respectively," they ...
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Source: HighBeam Research, Adjuvant immunotherapy using vaccinia viral lysates found ineffective.