Interferon Alpha A Cytokine That Is an Effective Adjuvant Treatment for Melanoma

Interferon-alpha, a biologic compound that has both antipro-liferative and immune modulatory activity in vitro and in vivo, has been tested in a number of Phase II studies in metastatic melanoma, yielding response rates of 10% to 25% with a small proportion of complete responses (CRs) and median survival of 6 to 9 months.42,43 Response rates appeared to be dose related. These modest results, however, have led to a number of trials of high-, moderate-, and low-dose interferon as adjuvant treatment in patients with resected intermediate (stage IIB and IIC) and high-risk (stage III lymph nodal) melanoma. In Europe, low-dose extended-duration regimens have been tested with fixed doses of 3 million units/m2 for up to 3 years. A total of seven well-conceived randomized trials have compared low-dose interferon to a control arm, usually observation (Table 20.2). For patients with high-risk disease, no differences in overall and relapse-free survival were observed in those six European and one American studies.44-48 For those with intermediate-risk disease, there is no clear survival benefit, but with brief follow-up, several studies have shown a relapse-free survival advantage to the low-dose interferon arm. However, in the most recently published and largest trial to date, the "AIM-HIGH" trial in the UK, which compared low-dose interferon for 3 years with observation, did not show any difference in either overall survival or time to relapse.49,50 In that study, 674 patients with stage IIB or III disease received either interferon at a dose of 3 million units subcutaneously three times a week for 2 years or observation. There was no difference in overall survival (odds ratio, 0.94; P = 0.6) or in relapse-free survival (odds ratio, 0.91; P = 0.3). The overall survival at 5 years was 44%, interestingly, considerably better than the 37% figure for the interferon arm of the EST 1684 trial that resulted in U.S. Food and Drug Administration (FDA) approval for high-dose interferon.51 In an editorial that accompanied the recent publication of the results of the AIM-HIGH trial, it was concluded that except for the nearly mature EORTC 18952

TABLE 20.2. Low-dose interferon-alpha trials for adjuvant therapy of melanoma.

Outcome

TABLE 20.2. Low-dose interferon-alpha trials for adjuvant therapy of melanoma.

Outcome

Reference

Cooperative group (PI)

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