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
10.3760/cma.j.issn.1004-4221.2013.02.012
- VernacularTitle:局部晚期鼻咽癌调强放疗同期化疗前TPF诱导化疗Ⅰ和Ⅱ期临床研究
- Author:
Qun ZHANG
;
Fang HE
;
Dehua KANG
;
Zhenyu WANG
;
Bixiu WEN
;
Wei LUO
- Publication Type:Journal Article
- Keywords:
Nasopharygeal neoplasms/chemotherapy;
Chemotherapy,neoadjuvant;
Adverse effect;
Dose escalation trial
- From:
Chinese Journal of Radiation Oncology
2013;(2):129-132
- CountryChina
- Language:Chinese
-
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 Thirtythree 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.
