Studies on the pharmacodynamics of floxuridine in patients with trophoblastic neoplasms

OBJECTIVE: To evaluate the efficacy and adverse effects of floxuridine in the treatment of patients with trophoblastic neoplasms, and to compare that of floxuridine with 5FU. METHODS: 19 patients were enrolled and divided into single drug chemotherapy (FUDR/5FU) group or combination chemotherapy (FUDR + KSM/5FU + KSM) group. With the cross-over self-control way, 9 patients in the single drug chemotherapy group were intravenously infused FUDR or 5FU for 8 hr, respectively. 10 patients in the combination chemotherapy (FUDR + KSM/5FU + KSM) group were administered FUDR + KSM or 5FU + KSM as intravenous infusion for 8 hr. β-HCG level, WBC, neutrocyte, platelets counts before and after chemotherapy were recorded respectively. Nausea, vomiting and liver function were recorded as the adverse effects. The efficacy of chemotherapy was estimated as log(β-HCG_{before chemotherapy}/β-HCG_{after chemotherapy}). RESULT: The same value of log(β-HCG_{before chemotherapy}/β-HCG_{after chemotherapy}) in patients administered FUDR or FUDR + KSM was obtained as that of patients administered 5FU or 5FU + KSM. The incidence of hematological toxicity of FUDR was greater than that of 5FU, and the gastrointestinal adverse event following 5FU intravenous infusion were much more than that of FUDR. The correlation between the pharmacokinetics and pharmacodynamics of FUDR was not found yet. CONCLUSION: FUDR showed the same efficacy and safety as that of 5FU in the treatment of patients with trophoblastic neoplasms. It may also be used in substitute of 5FU in single drug or multiple-drugs chemotherapy.