Efficacy

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Trials have studied the role of interferon alfa in high- and low-dose regimens.

High-dose interferon

An early RCT of high-dose treatment (intravenous interferon alfa-2b 20 MU/day for 1 month, followed by10 MU three times weekly for 11 months) in 287 people with lesions greater than 4 mm in depth at presentation showed a significant improvement in disease-free and overall survival compared with those treated with surgery alone. The overall survival in the interferon group was 3-1 years, compared with 2-8 years treated with surgery alone.46 However, in a larger study of 642 patients there was no difference in the overall survival of patients with either high- or low-dose interferon alfa compared with no further therapy.47 A recent study from the same authors compared high-dose interferon alfa-2b with vaccine treatment (GM2-KLH/QS-21) in patients with resected stage IIB-III melanoma of the skin.48 A total of 880 patients were randomised equally between the two interferon alfa and vaccine groups. The trial demonstrated a significant treatment benefit for those receiving interferon alfa-2B in both relapse-free survival (hazard ratio 1-47, CI 1-14-1-90, P= 0-0015) and overall survival (hazard ratio 1-52, CI 1-07-2-15, P = 0-009). There was no control (observation only) arm so a direct comparison with no adjuvant treatment could not be made. However, based on comparisons with the observation arm of previous adjuvant trials, the outcome for patients receiving the vaccine seemed to be no worse than for similar patients receiving observation only. This study therefore seems to have confirmed the relapse-free survival and overall survival benefits of high-dose interferon reported earlier.46

Are there any effective adjuvant treatments?

Low-dose interferon

To date, two clinical trials have used low-dose subcutaneous interferon (3 MU three times weekly) in patients presenting with lesions greater than 1-5 mm in depth but with negative lymph nodes. In the first trial of 499 patients this regimen was continued for 18 months and compared with surgery alone. There was a significant extension of the relapse-free interval and a trend towards extension of overall survival.49 The second trial randomised 311 patients to receive treatment for 12 months versus observation only, after surgical removal of the melanoma. At 41 months relapse-free survival was prolonged but overall survival was not.50

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