小児造血器腫瘍に対するVindesineの第2相試験および急性リンパ性白血病に対するVincristineとの第3相臨床比較試験

抄録

Eighty-eight children with leukemia and lymphoma with or without previous treatment were treated with vindesine alone in a dose of 2 to 3 mg per m² weekly or in combination with prednisolone and others.
Five (20%) of 20 patients treated by vindesine alone achieved complete remission. Thirty-one (46%) of 68 patients treated by combination chemotherapy of vindesine with prednisolone or L-asparaginase and others achieved complete remission. A diagnosis of the most patients was acute lymphocytic leukemia and 75% of patients who obtained complete remission had been treated with vincristine previously.
Our data suggested that there was no obvious cross resistance between vincristine and vindesine. Myelosuppression, neurotoxicity, liver dysfunction and epilation were major relevant adverse effects.
A phase III evaluation comparing vindesine versus vincristine in combination with prednisolone and L-asparaginase was done for 26 previously untreated children with acute lymphocytic leukemia. It would appear that vindesine in a dose of 3 mg per m² once weekly in combination with prednisolone and L-asparaginase was optimal and equally effective as vincristine in a dose of 1.5 mg per m² once weekly.
Neurotoxicity and other side effects of vindesine were less severe and less toxic than have been noticed with vincristine.