Early stage II phase clinical trial of hydrochloric acid Irinotecan (CPT-11) for skin malignant tumor.

概要

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An early phase II study of CPT-11 involving patients with several malignant skin tumors was conducted at 6 institutions in Japan.The following four administration schedules were used: a weekly dose of 100mg/m2 (Arm A), a biweekly dose of 150mg/m2 (Arm B), 200mg/m2 every 3-4 weeks (Arm C) and 50mg/m2 once or twice a week (Arm D) .An antitumor effect was observed against squamous cell carcinoma (SCC), malignant melanoma (MM), Paget's disease (PD) and Bowen's disease (BD), with the response rates being 36.4% (4/11), 11.1% (1/9), 20.0% (1/5) and 100% (1/1), respectively. The response rate was 25.0% (3/12) in Arm A, 0% (0/1) in Arm B, 14.3% (2/14) in Arm C, and 50.0% (2/4) in Arm D.Major adverse reactions consisted of leukopenia, anemia, nausea/vomiting, and diarrhea, with the incidence being 52.9%, 41.2%, 61.8%, and 29.4%, respectively, all reactions were tolerable. Nausea/vomiting and diarrhea were common just after starting the Arm C regimen and the incidence of diarrhea was high in Arm D.In conclusion, CPT-11 was effective against malignant skin tumors such as SCC, MM, DC, and PD. MM and SCC show a high level of malignancy and no satisfactory chemotherapy has yet been established for them. Therefore, a late phase II study seems to be justifiable for SCC and MM at a dose of 100mg/m2 weekly.
日本皮膚悪性腫瘍学会の論文