Table 1. Adjuvant Trials With Interferon-alpha |
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Study |
Agent |
Patients |
Stage |
Dose (MU)/Schedule |
Results |
| ECOG E168414 | IFN-a
2b vs OBS |
287 | IIB/III | 20 /m²/IV x 5 days/wk x 4 wks, then 10 /m²/SQ/TIW x 48 wks |
(+) OS (p= 0.047) (+) DFS (p= 0.004) |
| ECOG E16915 | IFN-a
2b (high vs low) vs OBS |
642 | IIB/III | 20 /m²/IV x 5 days/wk x 4 wks, then 10 /m²/SQ/TIW x 48 wks or 3 /SQ/TIW x 2 years |
Preliminary analysis (-) OS but (+) DFS |
| WHO #1616 | IFN-a
2a vs OBS |
444 | III | 3 /SQ/TIW x 3 years | (-) OS and DFS (p= NS) |
| NCCTG17 83-7052 |
IFN-a
2a vs OBS |
262 | II¹/III | 20 /m²/IM x 5 days/wk x 12 wks | (-) OS and DFS (p= NS) |
| SWOG 864218 | IFN-g
vs OBS |
134 | II/III | 0.1 mg SQ TIW x 1 year | (-) OS and DFS (p= NS) |
| France19 (Grob et al) |
IFN-a
vs OBS |
493 | IIA/IIB | 3 /SQ/TIW x 18 months | (+) DFS (p= 0.03) OS needs longer f/u |
| Austria20 (Pehamberger et al) |
IFN-a
vs OBS |
311 | IIA/IIB | 3 /SQ/daily x 3 wks then, 3 /SQ/TIW x 12 months |
(+) DFS (p= 0.02) OS needs longer f/u |
| ECOG E1694 | IFN-a
2b vs GMK vaccine |
851 | IIB/III | 20 /m²/IV x 5 days/wk x 4 wks,
then 10 /m²/SQ/TIW x 1 year or GMK SQ/once weekly x 3 months |
Ongoing |
| EORTC 18-871 |
IFN-a
2a vs IFN-g vs OBS |
800 | II²/III | 1 /SQ/TIW x 1 year 0.2 mg /SQ/TIW x 1 year |
Ongoing |
| EORTC 18-952 |
IFN-a
2a vs OBS |
1000 | IIB/III | 10 /SQ/5 days/wk x 4 wks, then 10 /SQ/TIW x 1 year or 5 /SQ//TIW x 2 years |
Ongoing |
| ECOG E1697 | IFN-a
2b vs OBS |
1444 | IIA | 20 /m²/IV x 5 days/wk x 4 wks | Ongoing |
| UKCCCR | IFN-a
2a vs OBS |
1000 | II/III | 3 /SQ/TIW x 2 years | Ongoing |
ABBREVIATIONS: IFN = interferon; OBS= observation; MU = million units; IV = intravenous; IM = Intramuscular; SQ = Sub-cutaneous; TIW = 3 times a week; OS = Overall Survival; DFS = Disease Free Survival; NS = not statistically significant; GMK= name of an anti-ganglioside vaccine; ECOG = Eastern Cooperative Oncology Group; WHO = World Health Organization; NCCTG = North Central Cancer Treatment Group; SWOG = Southwestern Oncology Group; EORTC = European Organization for Research and Treatment of Cancer; UKCCCR = United Kingdom Coordinating Committee on Cancer Research; 1: > 1.69 mm thick ; 2: > 3mm thick |
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