title: Superselective Intra-arterial Infusion Chemotherapy with Nedaplatin for Oral Cancer: A Pharmacological Study of the Dose Clearance.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793 Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Miyake
authors.affiliation: Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793 Japan.
authors.forename: Yumiko
authors.initials: Y
authors.lastname: Ohbayashi
authors.affiliation: Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793 Japan.
authors.forename: Akinori
authors.initials: A
authors.lastname: Iwasaki
authors.affiliation: Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793 Japan.
authors.forename: Fumi
authors.initials: F
authors.lastname: Sawai
authors.affiliation: Department of Radiology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Toyama
authors.affiliation: Department of Radiology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Nishiyama
keywords: Chemotherapy; Dose clearance; Intra-arterial infusion; Nedaplatin; Superselective