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
ZHANG Qun*, HE Fang, KANG De-hua, WANG Zhen-yu, WEN Bi-xiu,LUO Wei
*Department of Radiation Oncology, Cancer Center of Sun Yat-Sen University, State Key Laboratory of Oncology in Southern China, Guangzhou 510060,ChinaCorresponding author:LUO Wei, Email:luowei2@mail.sysu.edu.cn
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 docetaxel and fluorouracil were 60 mg/m2 d1 and 550 mg/m2 d1—5, respectively, the MTD of cisplatin was 65 mg/m2 d1. 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 d1), cisplatin (65 mg/m2 d1), and fluorouracil (550 mg/m2 d1—5), which is repeated every 3 weeks, is proved safe and effective for Asian patients with locally advanced NPC.
ZHANG Qun*,HE Fang,KANG De-hua et al. 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[J]. Chinese Journal of Radiation Oncology, 2013, 22(2): 129-132.
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2013, Vol. 22 
