Interferon therapy slows relapse, prolongs survival in patients with advanced melanoma

Patients with high-risk melanoma who used an interferon-based treatment were significantly more likely to survive than those treated with an experimental immune vaccine, a national clinical trial has found.

The study – the largest randomized clinical trial to date of high-dose interferon alfa-2b – reinforced findings from previous multicenter randomized trials that interferon therapy can delay cancer relapse and save the lives of patients with stage IIb/III melanoma. Interferon is a protein produced by the body that boosts the immune system and also directly inhibits melanoma.

Two-year survival in 395 patients randomized to receive interferon and 429 patients treated with the vaccine was 62 percent and 49 percent, respectively. Patients treated with interferon relapsed and died 33 percent less frequently than patients treated with a vaccine. All 774 patients had surgery prior to treatment on this trial to remove melanoma tumors.

Because of the positive trend in survival differences, the trial was stopped by its Data Safety Monitoring Committee last June, after a median patient follow-up of 16 months.

“High-dose interferon alfa-2b is the first treatment to show any significant survival benefit in patients with advanced melanoma,” says the lead author, John Kirkwood, MD, Director of the Melanoma Center at the University of Pittsburgh. “There is no question that high-dose interferon should be the treatment of choice for patients with operable, high-risk melanoma, and is a firm platform from which all further progress can be made.” Kirkwood is also studying the effect of interferon therapy before surgery, and in less advanced cancers in current prospective trials.

The experimental vaccine used in the trial was “ganglioside GM2,” which had been shown in a small study to produce an antibody response to melanoma cancer cells. But

while most patients did respond to the vaccine, the effects upon relapse rate and survival appear to be less than that offered by high-dose interferon.

The majority of patients on interferon therapy experienced significant flu-like symptoms.

“High-Dose Interferon Alfa-2b Significantly Prolongs Relapse-Free and Overall Survival Compared with GM2-KLH/QS-21 Vaccine in Patients with Resected Stage IIB-III Melanoma: Results of Intergroup Trial E1694/S9512/C509801.” John M. Kirkwood, et al.; University of Pittsburgh Medical Center, Pittsburgh, PA. Vol 19, No 9, (May) 2001, pp: 2370-2380.

The Journal of Clinical Oncology is the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world's leading professional society representing physicians who treat people with cancer.

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