Phase I / II clinical trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy followed by intensity-modulated radiotherapy and concomitant chemotherapy in locally advanced nasopharyngeal carcinoma

Abstract

Objective To investigate the maximum-tolerated dose （MTD） of cisplatin in docetaxel, cisplatin, and fluorouracil （TPF） induction chemotherapy followed by intensity-modulated radiotherapy （IMRT） and concomitant chemotherapy as well as the safety and short-term efficacy of TPF induction chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma （ NPC ）. Methods Thirty- three patients with locally advanced NPC were enrolled in this trial. The MTD of cisplatin was determined by dose escalation study, and the short-term efficacy and toxicities were evaluated. Results When the doses of doeetaxel and fluorouracil were 60 mg/m2 dl and 550 mg/m2 dl--5, respectively, the MTD of cisplatin was 65 mg/m2 dl. In this regimen （repeated every 3 weeks）, grade 3--4 toxicities included neutropenia （67%）, febrile neutropenia （9%）, diarrhea （21%）, and oral mucositis （6%）. Except those who experienced dose-limited toxicity, other patients completed the whole treatment schedule. After TPF induction chemotherapy, the overall response rate was 97%, and the complete response rate was 21%. Conclusions In the endemic areas of NPC, induction chemotherapy with docetaxel （60 mg/m2 dl ） , cisplatin （65 mg/m2 dl ）, and fluorouracil （550 mg/m2 dl--5）, which is repeated every 3 weeks, is oroved safe and effective for Asian natients with locallv advanced NPC. Key words: Nasopharygeal neoplasms/chemotherapy ; Chemotherapy, neoadjuvant ; Adverse effect; Dose escalation trial