[A phase II clinical trial of oral VP 16-213 in advanced non-Hodgkin's lymphoma]

Abstract

A phase II clinical trial of oral VP 16-213, a semisynthetic podophyllotoxin, was undertaken in twenty nine patients with advanced non-Hodgkin's lymphoma. All patients had received extensive prior chemotherapies including adriamycin, cyclophosphamide, vinka alkaloids and/or bleomycin and has become refractory to these drugs. The dosage of VP 16-213 was 200 mg/day p.o. bid for 5 days at 3 to 4-week intervals. There were 3 CRs (10.3%) and 6 PRs (20.7%) with a median duration of remission of 16 weeks ranging from 7 to 185+ weeks. Leukopenia less than 4 X 10(3)/cm3 and thrombocytopenia less than 100 X 10(3)/cm3 were seen in 80% and 26.7% of cases, respectively. Alopecia (100%), anorexia (44%) and nausea (26%) were observed but these were well tolerated. We conclude that the oral administration of VP 16-213 has considerable antitumor activity with no cross-resistance to vinka alkaloids, anthracyclines and alkylating agents.