Adjuvant interferon alpha 2b in high risk melanoma - the Scottish study

In 1989, the Scottish melanoma group initiated a randomized trial, comparin g observation alone with 6 months' therapy with low dose interferon a (give n subcutaneously 3 MU day(-1), thrice weekly), for patients with primary me lanomas of at least 3 mm Breslow thickness, or with evidence of regional no de involvement. The trial was closed in 1993 with only 95 eligible patients randomized. There were no toxic deaths, and no patient failed to complete the treatment for reasons of toxicity. 6 months' treatment with low-dose in terferon-cx resulted in a statistically significant improved disease-free s urvival for up to 24 months after randomization (P < 0.05). However, at a m edian follow-up of over 6 years, although there was an apparent improvement in disease-free survival (from 9 to 22 months), and overall survival (from 27 to 39 months), consistent with larger studies powered to detect such di fferences, these differences were not statistically significant. The data t herefore suggest that 6 months of low-dose interferon is active, and confir m the importance of the large randomized studies, such as the UKCCCR AIM-Hi gh and EORTC trials, that seek to confirm a possible survival advantage for low or intermediate dose interferon. (C) 2001 Cancer Research Campaign.