菌状息肉症に対するOH-6000後期臨床第II相試験

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A late phase II study of OH-6000 consisting of two phases, one to find the optimal dosage and regimen and the other to evaluate the clinical efficacy at the optimal dosage and regimen, was performed in patients with mycosis fungoides. This study was a multicenter study including 42 medical institutions nationwide. The drug was administered by the intramuscular route at a daily dose of 1×106 or 2×106 IU, 3 times a week on alternating days or 5 consecutive days a week.The optimal dosage and regimen was determined to be 1×106 or 2×106 IU, adjusted for adverse reactions and severity of symptoms, administered at least 5 consecutive days a week, for 8 or more successive weeks. Therefore, the latter phase of the study was performed with this dosage and regimen.Of a combined total of 38 completed cases in both study phases, complete response (CR) was observed in 3 and partial response (PR) in 19, for an overall response rate of 57.9%. The response rates in the individual study phases were 41.2% (7/17) in the dosage and regimen-finding phase and 71.4% (15/21) in the efficacy-evaluation phase.Adverse reactions were those commonly observed with other IFN-γ; none were serious and all were reversible.In conclusion, OH-6000 was considered to be a highly useful drug in the treatment of mycosis fungoides.
日本皮膚悪性腫瘍学会の論文