Abstract
“Multi-Center Clinical Trial of IFN-γ on Mycosis Fungoides in Post-Marketing Surveillance”A clinical trial was performed at 36 institutes to investigate the efficacy and safety of IFN-γ (Biogamma®) in 69 patients with mainly CTCL.The general improvement rate (CR and PR) was 37.7%, which was lower than that of phase II trials, which was 60.7%. This may be explained by the fact that the present study had about twice as many patients in advanced stage of the disease, such as tumor phase, than phase II.Patients administered 2million JRU of IFN-γ over 12 weeks showed the high improvement rate.Adverse effects and their frequency were almost same as those in premarketing clinical trials.Patients receiving a combination therapy, such as IFN-γ and PUVA, showed lower improvement rate as compared with those treated with IFN-γ alone. As much severe patients were assigned to the combination therapies, the improvement rate was considered lower in this group than others. More effective combination therapies must therefore be explored for patients in more advanced stages of CTCL.
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