Clinical trial of chemotherapy by superselective intra-arterial infusion of nedaplatin (CDGP) and 5-FU with concurrent radiotherapy for advanced oral cancer

Nedaplatin (CDGP) is one of the platinum-derivatives to further improve the anti-tumor effect and to reduce adverse effects of cisplatin, such as renal toxicity. The present study evaluated the efficacy and adverse events of chemotherapy by superselective intra-arterial infusion of CDGP and 5-fluorouracil (FU) combined with concurrent radiotherapy in patients with advanced squamous cell carcinoma of the oral cavity. Sixteen patients were treated with CDGP plus 5-FU in combination with concurrent irradiation of 40-60 Gy. Ten patients were treated as a preoperative therapy and 6 as a definitive therapy. The overall clinical response rate was 93.8% and histological effects according to the grading system of Shimosato et al. were seen in 13/16 (81.2%). Adverse events were observed in all patients. Mucositis, leucopenia and thrombocytopenia (>Grade 2) were seen in 13 (81.3%), 11(68.8%) and 8 (50.0%) of 16 patients, respectively. The overall 2-year and 4 months survival rate was 86.2%. One patient have died of disease and another of other causes. Concurrent chemoradiotherapy using CDGP plus 5-FU was tolerated with good clinical and histological effects, resulting in good local control for advanced oral carcinoma. (author)