Clinical evaluation of anti-tumor effect of carboplation on oral squamous cell carcinoma

—multi-center study—

Abstract

Multi-center study to evaluate the anti-tumor effect and toxicity of carboplatin (CBDCA) on oral squamous cell carcinoma was conducted. Thirty-four patients, 28 males and 6 females aged 38 to 78 years (mean age 63 years) who agreed to participate in this trial were selected from 7 hospitals. CBDCA (300-400mg/m²) combined with UFT (400mg/m²/day, p.o.) or 5-FU (250-500mg/body/day, i.v. or i.a.) was administered intravenously to these patients.
The clinical response was evaluated 4 weeks after beginning this study. Seven patients were excluded from evaluation of the anti-tumor effect caused by irregular course of admini-stration of medicines and another one was unmeasurable 4 weeks later. Therefore, the response could be evaluated in 26 patients UFT was administrated to 22 of 26 patients for 4 weeks and 5-FU to 4 patients for 4 or 5 days immediately after prescription of CBDCA. Eighteen of the 26 patients were previously untreated and 8 had been recurrent cases. In a distribution of stage in these 18 previously untreated patients, 3 were stage II, 6 stage III and 9 stage IV cases. For evaluation of CBDCA toxicity, all 34 cases were used. A complete response was obtained in two cases and partial response in 9 cases, the overall response rate was 42.3%. Among the 18 previously untreated patients, a complete response was obtained in 2 cases and partial response in 7 cases (response rate 50.0%) . Among the 8 recurrent cases, a partial response was observed in only 2 cases (response rate 25.0%) . In stage IV cases, the highest response rate (66.7%) was obtained. In stages II and III, 33.3% of the patients showed a partial response respectively. Relatively severe myelosuppression was observed. Thrombocytopenia occurred in 55.8% of 43 courses (34 patients), leukocytopenia occurred in 58.1% and a decrease of hemoglobin was observed in 74.4%. Grade IV thromboocytopenia occurred in two courses and grade IV leukocytepenia in one course. Nausea occurred in 10 of the 34 patients and vomiting in 4 patients. Granisetron was useful to prevent to nausea and vomiting caused by CBDCA.