No RCTs of alfa interferon in CTCL have been reported, except as combination therapy (see above).

In an open study, 20 heavily pretreated patients (stage IB-III) were given maximum tolerated doses of alfa interferon (50 MU/m2 intramuscularly three times weekly) for 3 months.33 An OR rate of 45% was reported, with a median response duration to maximum tolerated doses of alfa interferon of 5 months.

A subsequent non-randomised study revealed response rates of 64% in 22 patients (stage IA—IVA) with an overall CR rate of 27%.34 Objective responses were greater in the group treated with an escalating-dose schedule of alfa interferon (36 MU/day) compared with those on a low-dose regimen (3 MU/day) for 10 weeks (78% versus 37%) but overall numbers were too small for statistical comparison.

An open study of 43 patients treated with escalating doses (3-18 MU daily) of alfa interferon showed an OR rate of 74%, with a CR rate of 26%.35 Responses were more common in those who had not had prior treatment and in those with stage I/II (88%) than in those with stage III/IV (63%) disease. DFS was 21% at 55 months.

A phase II study of intermittent high-dose interferon alfa-2a given on days 1-5 every 3 weeks (mean dose 65-5 MU/m2/week) showed a response rate of 29%, with only one CR in 24 patients with advanced (IVA/B) refractory CTCL.36 Dose reductions were necessary and no improved responses were seen in those patients receiving dose escalation.

In an open study, 45 patients with CTCL, including 13 patients with Sezary syndrome, received low-dose alfa interferon (6-9 MU daily) for 3 months and those responding were continued on alfa interferon alone while non-responders were given alfa interferon plus acitretin, 0-5 mg/kg/day.37 After 12 months' therapy 62% achieved PR or CR, including 11 patients on combined therapy. However, this study design does not exclude the possibility that the response in the alfa interferon non-responder group was due to a delayed efficacy from continued alfa interferon therapy after 3 months.

Intralesional alfa interferon (1-2 MU three times weekly for 4 weeks) can induce complete regression of individual plaques (10 of 12 sites) compared with placebo-treated sites (1 of 12 sites).38

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