Adjuvant Therapy: Melanoma

Table 2

Phase III studies of IFN-α for metastatic melanoma.

Study reference	No of patients eligible for analysis	TNM stage	Therapy and IFN subspecies	Dose and schedule—treatment arm	Median followup at time of reporting (yrs)	Median DFS (mths)	Median OS (mths)	% Node- positive
				High dose
NCCTG 83-7052 [20]	262	II–III (T2-4N0M0/TanyN + M0)	IFN-α2a versus observation	IM 20 MU/m^2 thrice weekly for 4 months	6.1	NS	NS	61
ECOG E1684 [21]	287	II–III (T4N0M0/TanyN + M0)	IFN-α2b versus observation	IV 20 MU/m^2 5 days a week for 4 weeks → then →SC 10 MU/m^2 3 days a week for 48 weeks	12.6	6.9	S (at 6.9 yrs) NS (at 12 yrs)	89
ECOG E1690 [22]	642	II–III (T4N0M0/TanyN + M0)	IFN-α2b—high dose versus low dose versus observation	High dose: IV 20 MU/m^2 5 days a week for 4 weeks → then → SC 10 MU/m^2 3 days a week for 48 weeks; Low dose: SC 3MU/m^2 2 days a week for 2 years	6.6	4.3	NS	74
ECOG E1694 [23]	774	II–III (T4N0M0/TanyN + M0)	IFN-α2b versus GMK vaccine	IV 20 MU/m^2 5 days a week for 4 weeks → then → SC 10 MU/m^2 2 days a week for 48 weeks	2.1	62% (2yr) versus 49%	78% versus 73%	77
ECOG E2696 [25]	107	II–III–IV (stage IV:  resectable meta static disease)	IFN-α2b with GMK vaccine with and without induction	Induction: IV 20 MU/m^2 5 days a week for 4 weeks → then →SC 10 MU/m^2 3 days a week for 48 weeks; No induction: SC 10 MU/m^2 3 days a week for 48 weeks	2.4	S	S	Not available
				Intermediate dose
EORTC 18952 [31]	1388	II–III (T4N0M0/TanyN + M0)	IFN-α2b for 1 yr versus 2 yrs versus observation	IV 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 years	1.6	7.2% (NS)	5.4% (NS)	74
EORTC 18991 [91]	1256	III (TanyN + M0)	PEG IFN-α2b versus observation	SC 6 μg/kg/week for 8 weeks → then →SC 3 μg/kg/week for 5 years	3.8	45.6% versus 38.9% (NS)	NS	100
				Low dose
Austrian melanoma cooperative group (AMCG) [92]	311	II (T2-4N0M0)	IFN-α2a versus observation	SC 3 MU 7 days a week for 3 weeks → then →SC 3 MU 3 days a week for 1 year	3.4	S	Not available	0
French melanoma cooperative group (FCGM) [93]	499	II (T2-4N0M0)	IFN-α2a versus observation	SC 3 MU 3 days a week for 18 months	>3	0.74 (HR), S	0.70 (HR), S	0
WHO melanoma program trial 16 [94]	444	III (TanyN + M0)	IFN-α2a versus observation	SC 3 MU 3 days a week for 36 months	7.3	NS	NS	100
Scottish melanoma cooperative group [45]	96	II–III (T3-4N0M0/TanyN + M0)	IFN-α2a versus observation	SC 3 MU 3 days a week for 6 months	>6	NS	NS	Not available
EORTC 18871/DKG 80-1 [42]	728	II–III (T3-4N0M0/TanyN + M0)	IFN-α2b versus IFN-γ versus ISCADOR M versus observation	IFN-α2b: SC 1 MU every other day for 12 months; IFN-γ: SC 0.2 mg every other day for 12 months	8.2	NS	NS	58
UKCCCR/AIM HIGH [44]	674	II–III (T3-4N0M0/TanyN + M0)	IFN-α2a versus observation	SC 3 MU 3 days a week for 24 months	3.1	NS	NS	Not available
DeCOG [95]	840	III (T3anyN + M0)	IFN-α2a	SC 3 MU 3 days a week for 18 months (A) versus 5 yrs (B)	4.3	81.9% versus 79.7% NS	85.9% versus 84.9% NS	Not available
DeCOG [34]	444	III (TanyN + M0)	IFN-α2a	SC 3 MU 3 days a week for 24 months (A) versus SC 3 MU 3 days a week for 24 months + DTIC 850 mg/m^2 every 4–8 weeks for 24 months (B) vesus observation (C)	3.9	HR: 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.