Introduction: Nedaplatin (cis-diammine-glycolate platinum) is a new anticancer agent developed in Japan. It is especially designed to reduce adverse side effects of CDDP such as renal toxicity and neurotoxicity.
Aim: We used nedaplatin as a superselective intra-arterial infusion chemotherapy for oral cancers and carried out a pharmacological study of the dose clearance of nedaplatin based on renal function as well as evaluating its efficacy, including hematological side effects.
Patients and methods: Typical regimens of this chemotherapy consisted of 5-days straight of 24-h continuous intravenous infusion of 5-Fu with a single shot of nedaplatin via transfemoral artery on day 4. The dose of nedaplatin was calculated based on the 24-h creatine clearance. A total of 37 patients who had oral cancer and had received 68 courses (total) of chemotherapy were found to be eligible for this study.
Results: Total and free platinum concentrations in the plasma were measured at each of the time points, and the area under the curve (AUC, measured in units of µg h/ml) was calculated based on the platinum concentration with the following formula: CL (clearance of free platinum: l/h) = 0.042 × CCr (ml/min) + 5.84. The response rate was 70.1 % (in CR 51 %, in PR 19 %). Histological CR was seen in 28.6 % of surgical specimens. Moderate hematological side effects were seen. However, severe adverse events were not observed, including those associated with cannulation of the femoral artery.
Conclusion: The dose-clearance formula that was established by our study can most likely be utilized to accurately predict the optimal administered dose of nedaplatin for arterial infusion chemotherapy.
Keywords: Chemotherapy; Dose clearance; Intra-arterial infusion; Nedaplatin; Superselective.