Clinical usefulness of iv injected Cepharanthin (biscoclaurin alkaloid) in leukopenia induced by radiation therapy

A multi-institutional double-blind randomized study was designed to evaluate the clinical usefulness and the optimum dosage of Cepharanthin (KS-102) in leukopenia induced by radiation therapy. A total of 135 cancer patients were allocated to receive 10 mg (30 patients), 50 mg (34), 100 mg (36), or placebo(35) after giving written or oral informed consent. Two ampules of KS-102 were iv injected once a day, beginning with irradiation for 4 weeks. There were no significant differences in background factors among the four groups. KS-102 was significantly effective in both the 50 and 100 mg groups as compared with the placebo group. Although there was no significant difference in either safety or usefulness among the groups, usefulness of KS-102 tended to be dose-dependent. An average WBC count was significantly larger in both the 50 mg and 100 mg groups 3 and 4 weeks after irradiation; and in the 100 mg group 2 weeks after irradiation, at the completion of irradiation, and one and 4 weeks after the completion. Based on efficacy criteria for the maintenance of WBC count of 3,000/mm3 or more, KS-102 was significantly effective in both the 50 mg and 100 mg groups 3 weeks after irradiation, and in the 100 mg group one week after the completion, as compared with the placebo group. In view of the rate of decreased WBC count, it was significantly effective in both the 50 mg and 100 mg groups at the completion of irradiation and in the 100 mg group 4 weeks after the completion. Side effects, such as vascular pain, paralysis, and redness, were seen in 3 patients given placebo, 5 patients given 50 mg, and 4 patients given 100 mg, with no statistically significant difference. One patient had drug-relatd transient abnormality in laboratory findings. KS-102 was found safe and useful by the consecutive iv injection of 50 mg/day or 100 mg/day. (N.K.)