インターフェロンアルファ‐２ａ（遺伝子組換え）の皮膚悪性腫ように対する臨床試験

Abstract

With Interferon Alpha-2a (Recombinant), a multi-centered clinical study was performed at 24 institutes in patients with such skin cancers as mycosis fungoides.In the most patients with mycosis fungoides, the interferon was administered intramusclary. On the other hand, in some patients with papulor- or tumor-type mycosis fungoides as well as those with skin metastatic malignant melanoma and epidermal cancers, the interferon was administered to all of their tumor lesions.The dosage regimen was as follows; 3 to 18 million (International Unit: IU) for intramuscle administration, or 3 to 9 million (IU) for local administration to the tumor lesions. Including 28 patients with mycosis fungoides, enrolled were total 40 patients with skin cancers such as ATL, skin metastatic malignant melanoma, epidermal cancers (extramammary paget disease, Bowen's disease, solar keratosis), of which 39 patients were eligible for safety evaluation and 35 were eligible for efficacy evaluation.As for mycosis fungoides, 11 of 23 patients who were eligible for efficacy with systemic administration (22 with intramuscle and 1 with subcutaneous administration) showed PR, and the efficacy rate of the interferon was 45%. In the cases of the other cancers, the intramuscle administration could lead PR in 2 of 2 eligible patients with ATL, and the local administration could lead PR in 2 of 3 with epidermal cancers and CR in 1 of 1 with malignant f olliculoma.With any route of the administration, such subjective and objective symptoms were observed mainly as fever, malaise, anorexia, headache, nausea/vomiting, and itching/ rash. As laboratory abnormalities, leucopenia thrombocytopenia, and SGOT/SGPT elevation were also seen. These adverse events were not irreversible nor clinically significant with any concerns.It was concluded that Interferon Alpha-2a is effective and tolerable for treatment of mycosis fungoides.