Table 2: Phase III studies of IFN-α for metastatic melanoma.

Study referenceNo of patients eligible for analysisTNM stageTherapy and IFN subspeciesDose and schedule—treatment armMedian followup at time of reporting (yrs)Median DFS (mths)Median OS (mths)% Node- positive

High dose

NCCTG 83-7052 [20]262II–III (T2-4N0M0/TanyN + M0)IFN-α2a versus observationIM 20 MU/m2 thrice weekly for 4 months6.1NSNS61 

ECOG E1684 [21]287II–III (T4N0M0/TanyN + M0)IFN-α2b versus observationIV 20 MU/m2 5 days a week for 4 weeks then SC 10 MU/m2 3 days a week for 48 weeks12.66.9S (at 6.9 yrs) NS (at 12 yrs)89 

ECOG E1690 [22]642II–III (T4N0M0/TanyN + M0)IFN-α2b—high dose versus low dose versus observationHigh dose:
IV 20 MU/m2 5 days a week for 4 weeks then SC 10 MU/m2 3 days a week for 48 weeks
Low dose:
SC 3MU/m2 2 days a week for 2 years
6.64.3NS74 

ECOG E1694 [23]774II–III (T4N0M0/TanyN + M0)IFN-α2b versus GMK vaccineIV 20 MU/m2 5 days a week for 4 weeks then SC 10 MU/m2 2 days a week for 48 weeks2.162% (2yr) versus 49%78% versus 73%77 

ECOG E2696 [25]107II–III–IV (stage IV:  resectable meta static disease)IFN-α2b with GMK vaccine with and without inductionInduction:
IV 20 MU/m2 5 days a week for 4 weeks then SC 10 MU/m2 3 days a week for 48 weeks
No induction:
SC 10 MU/m2 3 days a week for 48 weeks
2.4SSNot available

Intermediate dose

EORTC 18952 [31]1388II–III (T4N0M0/TanyN + M0)IFN-α2b for 1 yr versus 2 yrs versus observationIV 10 MU 5 days a week for 4 weeks then SC 10 MU 3 days a week for 1 year OR SC 5 MU 3 days a week for 2 years1.67.2% (NS)5.4% (NS)74 

EORTC 18991 [91]1256III (TanyN + M0)PEG IFN-α2b versus observationSC 6 μg/kg/week for 8 weeks then SC 3 μg/kg/week for 5 years3.845.6% versus 38.9% (NS)NS100

Low dose

Austrian melanoma cooperative group (AMCG) [92]311II (T2-4N0M0)IFN-α2a versus observationSC 3 MU 7 days a week for 3 weeks then SC 3 MU 3 days a week for 1 year3.4SNot available0 

French melanoma cooperative group (FCGM) [93]499II (T2-4N0M0)IFN-α2a versus observationSC 3 MU 3 days a week for 18 months>30.74 (HR), S0.70 (HR), S0 

WHO melanoma program trial 16 [94]444III (TanyN + M0)IFN-α2a versus observationSC 3 MU 3 days a week for 36 months7.3NSNS100 

Scottish melanoma cooperative group [45]96II–III (T3-4N0M0/TanyN + M0)IFN-α2a versus observationSC 3 MU 3 days a week for 6 months>6NSNSNot available

EORTC 18871/DKG 80-1 [42]728II–III (T3-4N0M0/TanyN + M0)IFN-α2b versus IFN-γ versus ISCADOR M versus observationIFN-α2b:
SC 1 MU every other day for 12 months
IFN-γ:
SC 0.2 mg every other day for 12 months
8.2NSNS58

UKCCCR/AIM HIGH [44]674II–III (T3-4N0M0/TanyN + M0)IFN-α2a versus observationSC 3 MU 3 days a week for 24 months3.1NSNSNot available

DeCOG [95]840III (T3anyN + M0)IFN-α2aSC 3 MU 3 days a week for 18 months (A) versus 5 yrs (B)4.381.9% versus 79.7% NS85.9% versus 84.9% NSNot available

DeCOG [34]444III (TanyN + M0)IFN-α2aSC 3 MU 3 days a week for 24 months (A) versus SC 3 MU 3 days a week for 24 months + DTIC 850 mg/m2 every 4–8 weeks for 24 months (B) vesus observation (C)3.9HR: 0.69 (A) versus 1.01 (B) versus 1.0 (C)HR: 0.62 (A) versus 0.96 (HR) (B) versus 1.0 (C)100%

Keys: NS—not significant; S—significant; HR—hazard ratio.