Intermediate dose recombinant interferon-alpha as second-line treatment for patients with recurrent cutaneous melanoma who were pretreated with low dose interferon

BACKGROUND. Interferon (IFN) is widely considered the most effective agent in the adjuvant therapy of patients with cutaneous melanoma (CIM). However, little is known about the effect of IFN on pretreated CR I patients who ex perience disease recurrence. The authors conducted a Phase II study to dete rmine whether intermediate doses of IFN could be beneficial for these patie nts. METHODS. A series of 24 consecutive CM patients who had undergone surgery f or local, in-transit, or lymph node disease recurrence during adjuvant ther apy with low dose IFN (IFN alpha-2b, 3 million units [MU] per day, three ti mes per week) were enrolled for second-line therapy with intermediate dose IFN (IFN alpha-2b, 10 MU per day) for one year. RESULTS. IFN was discontinued in 7 patients (29.2%) because of toxicity. Se veral patients complained of impairment in their daily activities. Progress ion of disease was registered in 17 patients (70.8%), with a median disease free survival of 5.5 months (95% confidence interval, 3.4-14.2). The media n follow-up for the 7 patients who did not experience disease recurrence wa s 15 months (range, 13-22 months). CONCLUSIONS, An increased dose of IFN as second-line adjuvant treatment was poorly tolerated and produced negative clinical outcomes in patients with CM. However, these patients probably were unresponsive to IFN regardless of the dosage level. In fact, the first adjuvant IFN treatment was ineffectiv e in all patients. Thus, the key factor in the treatment of CM seems to be patient responsiveness to IFN rather than the total dosage achieved. Cancer 2000;89:1490-4. (C) 2000 American Cancer Society.