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Vaccinia melanoma cell lysates do not extend survival of melanoma patients.
2003 JAN 1 - (NewsRx.com & NewsRx.net) -- by Maria G. Essig, MS, ELS, senior medical writer - Phase II clinical trial results indicated that treatment of malignant melanoma with a vaccine containing vaccinia melanoma cell lysates (VMCL) did not significantly increase relapse-free survival or overall survival, but the data confidence intervals suggest that the treated patients may benefit.
"Patients with high-risk melanoma treated by immunotherapy with vaccinia viral lysates were found in phase II studies to have improved survival compared with historical controls," said Peter Hersey at Newcastle Mater Hospital and colleagues throughout Australia. "We therefore elected to test this therapy in a phase III study."
The investigators randomly assigned 700 patients with American Joint Committee on Cancer stage IIB and III melanoma to receive immunotherapy with a vaccine prepared from VMCL for 2 years after surgery (treatment group, n=353) or to undergo surgery only (control group, n=347). Relapse-free survival (RFS) and overall survival (OS) of the two groups were compared.
At a median follow-up of 8 years, treated patients had a median OS of 151 months compared with 88 months for the control patients (hazard ratio, 0.81; 95% confidence interval, 0.64 to 1.02; p=0.068). At 5 years, the survival rate for patients in the treated group was 60.6% compared with 54.8% for control subjects. At 10 years, survival rates were 53.4% and 41%, respectively.
Patients in the treatment group had a median RFS of 50.9% at 5 years compared with 46.8% in the control group.
"Immunotherapy ...
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Source: HighBeam Research, Vaccinia melanoma cell lysates do not extend survival of melanoma...