Radiation therapy and concomitant weekly paclitaxel for locally advanced nasopharyngeal carcinoma: outcomes of a phase I trial
- VernacularTitle:常规放疗加每周紫杉醇治疗局部晚期鼻咽癌的临床Ⅰ期试验
- Author:
Ming CHEN
;
Shaoxiong WU
;
Yuanyuan CHEN
;
Al ET
- Publication Type:Journal Article
- Keywords:
nasophayngeal neoplasms;
paclitaxel;
concurrent chemoradiotherapy
- From:
China Oncology
2001;0(03):-
- CountryChina
- Language:Chinese
-
Abstract:
Purpose:A phase I trial of radiotherapy concomitantly with weekly paclitaxel was carried out to define the maximal tolerant dose (MTD) by describing the dose limiting toxicity (DLT) of paclitaxel given as a 3 hour Ⅳ infusion in patients with locally advanced nasopharyngeal carcinoma (NPC). Methods:Patients with locally advanced NPC were enrolled into a prospective, dose escalating phase I study. Toxicity was graded according to CTC 2.0. MTD was defined when two out of six patients developed DLT. The starting dose of paclitaxel was 20 mg/m 2 once weekly IV over 3 hours, with a subsequent dose escalation of 10 mg/m 2 in cohorts of three new patients. Radiation therapy was administered with conventional technique over 7 weeks in 2.0 Gy/daily fractions for 5 days/week up to total doses of 68～70 Gy.Results:From December 2000 to June 2001, sixteen patients completed chemoradiotherapy, and all of them were eligible for toxicity evaluation. On the first dose level (20 mg/m 2 ) no patient experienced DLT. On the next dose level with 30 mg/m 2 , one patient experienced DLT with grade Ⅲ mucositis for 5 weeks, and among the additional 3 patients no one developed DLT. On the third dose level with 40 mg/m 2 , one patient developed grade Ⅲ mucositis for 4 weeks and another suffered from grade Ⅲ dermatitis for 4 weeks. In order to make the trial more credible, another 4 patients were added to 30 mg/m 2 level, and no DLT occurred. Thus, the accumulation of patients stopped. After a median follow-up 12 months, one patient died of multiple bone metastases. One patient needed an operation to eradicate the residual right upper cervical lymph node 3 months after radical irradiation. Fourteen patients survived with disease free condition.Conclusions:When paclitaxel is given weekly as a 3 hour infusion concomitant to conventional radiotherapy for locally advanced NPC, MTD is 30 mg/m 2 with mucositis and dermatitis as DLT, and other toxicities are mild.
