Phase Ⅰ study of TPF neoadjuvant chemotherapy followed by radical radiotherapy in advanced nasopharyngeal carcinoma
- VernacularTitle:TPF诱导化疗治疗局部晚期鼻咽癌的Ⅰ期临床研究
- Author:
Guo LING
1
,
2
;
Lin HUAN-XIN
;
Xu MIN
;
Chen QIU-YAN
;
Wang CHENG-TAO
;
Huang PEI-YU
Author Information
1. 华南肿瘤学国家重点实验室,广东广州,510060
2. 中山大学肿瘤防治中心鼻咽癌科,广东广州,510060
- Keywords:
Nasopharyngeal carcinoma;
neoadjuvant chemotherapy;
radiotherapy;
docetaxeI;
cisplatin;
5-fluorouracil
- From:Chinese Journal of Cancer
2010;29(2):143-147
- CountryChina
- Language:Chinese
-
Abstract:
Background and Objective: PF regimen is the standard chemotherapy for advanced head and neck cancers including nasopharyngeal cancer. Recently PF has been found to enhance the tumor control by addition of taxotere. The purpose of this study was to evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of TPF neoadjuvant regimen [taxotere, cisplatin (DDP) and 5-fluorouracil (5-FU)]followed by radical radiotherapy in advanced nasopharyngeal carcinoma (NPC). Methods: Between December 2006 and May 2008, 41 patients with newly diagnosed UICC stage Ⅲ or Ⅳ advanced nasopharyngeal cancer were enrolled. There were 29 male and 12 female patients, with a median age of 47 years (range 29-60 years), and ECOG performance status ≤ 2.The initial dose was taxotere 40 mg/m~2 d1, DDP 40 mg/m~2 d1, and 5-FU 400 mg/m~2 d1-5. The treatment was repeated every 3 weeks for two cycles. Each dose of taxotere and DDP was increased by 5 mg/m~2 and 5-FU by 50 mg/m~2, respectively. The dose was escalated after six patients completed two cycles at the initial dose and DLT was assessed. Radiotherapy was started from the 5th week, with 68-72 Gy/34-36 fractions delivered to the nasopharynx and 60-66 Gy/30-33 fractions to the node-positive area.Results: Forty patients (79 cycles) were evaluated for toxicity and efficacy of the therapy. No DLT occurred at the dose levels 1-4. At dose level 5, three of six patients experienced DLT including grade Ⅲ/Ⅳ neutropenia lasting more than 1 week. Two of them also had grade Ⅲ mucositis, leading to the interruption of radiotherapy for more than 1 week. Three more new patients were retreated with the same dose (at dose level 6) under the G-CSF support, and no DLT occurred. Dose escalation continued to level 7, and DLT was found in all of the four patients, including three grade Ⅳ neutropenia, one of them had fever and pneumonitis; three grade Ⅲ diarrhea; and one grade Ⅲ mucositis lasting 10 days. Dose escalation was stopped and three more new patients were treated again at dose level 5 and no DLT was found. Other severe toxicities included grade Ⅲ anemia (1),grade Ⅲ vomiting (4), and grade Ⅲ weight loss (9). No severe hepatic and renal toxicities were found. Conclusions: TPF neoadjuvant chemotherapy is a safe and effective regimen in the treatment of advanced NPC, with recommended doses of taxotere 60 mg/m~2 dl, DDP 60 mg/m~2 d1, and 5-FU 600 mg/m~2 d1-5.
