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Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon Alfa-2b compared with high-dose interferon Alfa-2b for Resected stage III cutaneous melanoma . PURPOSE To compare the overall survival ( OS ) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b ( IFN-alpha-2b ) with the OS achieved using high-dose IFN-alpha-2b . PATIENTS AND METHODS An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003 . Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-alpha-2b ( arm 1 ) or high-dose IFN-alpha-2b alone for 1 year ( arm 2 ) . Active specific immunotherapy was injected subcutaneously ( SC ) weekly for 4 weeks , at week 8 , and bimonthly thereafter . IFN-alpha-2b SC was begun on week 4 and continued thrice weekly at 5 MU/m2 for 2 years . IFN-alpha-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen . RESULTS Median follow-up time was 32 months for all patients and 42 months for surviving patients . Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 ( P = .56 ) . Five-year OS rate is 61 % in arm 1 and 57 % in arm 2 . Estimated 5-year relapse-free survival ( RFS ) rate is 50 % in arm 1 and 48 % in arm 2 , with median RFS times of 58 and 50 months , respectively . The incidence of serious adverse events as a result of treatment was the same in both arms , but more severe neuropsychiatric toxicity was seen in arm 2 . CONCLUSION OS and RFS achieved by active specific immunotherapy and low-dose IFN-alpha-2b were indistinguishable from those achieved by high-dose IFN-alpha-2b . Long RFS and OS times were observed in both treatment arms .
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Intervention_Pharmacological
allogeneic melanoma lysate vaccine with low-dose interferon Alfa-2b
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Intervention_Pharmacological
high-dose interferon Alfa-2b
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Intervention_Pharmacological
specific immunotherapy and low-dose interferon alfa-2b ( IFN-alpha-2b )
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Intervention_Pharmacological
high-dose IFN-alpha-2b .
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Intervention_Pharmacological
active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-alpha-2b ( arm 1 )
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Intervention_Pharmacological
high-dose IFN-alpha-2b alone
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Intervention_Pharmacological
IFN-alpha-2b SC
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Intervention_Pharmacological
IFN-alpha-2b
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Intervention_Pharmacological
active specific immunotherapy and low-dose IFN-alpha-2b
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Intervention_Pharmacological
high-dose IFN-alpha-2b .
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Outcome_Physical
stage III melanoma
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Outcome_Other
Median follow-up time
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Outcome_Other
Median OS time
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Outcome_Mortality
Five-year OS rate
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Outcome_Mortality
Estimated 5-year relapse-free survival ( RFS ) rate
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Outcome_Adverse-effects
incidence of serious adverse events
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Outcome_Adverse-effects
neuropsychiatric toxicity
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Participant_Condition
Resected stage III cutaneous melanoma
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Participant_Condition
patients with resected stage III melanoma
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Participant_Sample-size
604 patients