Radiation therapy concurrent with weekly paclitaxel for locoregionally advanced nasopharyngeal carcinoma: outcomes of a phase I trial.
OBJECTIVE
The purpose of this study was to define the maximum tolerated dose (MTD) by describing the dose-limiting toxicity (DLT) of paclitaxel given as a 3-hour intravenous infusion concurrently with conventional radiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC).


METHODS
Patients with locoregionally advanced NPC were enrolled into a dose-escalating study. Toxicity was graded according to Common Toxicity Criteria 2.0. MTD was defined when 2 of 6 patients developed DLT. The starting dose of paclitaxel was 20 mg/m2 once weekly, with a subsequent dose escalation of 10 mg/m2 in cohorts of 3 new patients. Radiation therapy was administered in a conventional technique over 7 weeks in 2.0-Gy/daily fractions for 5 days/wk up to total doses of 68-70 Gy.


RESULTS
From November 2000 to June 2001, 16 patients completed chemoradiotherapy. On the first-dose level (20 mg/m2), no patient experienced DLT. On the next dose level with 30 mg/m2, 1 patient experienced DLT with grade 3 mucositis, which lasted for 5 weeks, and among the additional 3 patients, no one developed DLT. On the third dose level with 40 mg/m2, 1 patient developed grade 3 mucositis and another grade 3 dermatitis, and both of them lasted more than 3 weeks. To make the trial more credible, another 4 patients were added to the 30-mg/m2 level, and no DLT occurred. Thus, the accrual of patients stopped.


CONCLUSIONS
Combined modality with paclitaxel given weekly, as a 3-hour infusion concomitant to conventional radiotherapy, is feasible for locoregionally advanced NPC. The dose recommended for a phase II trial is 30 mg/m2 with mucositis and dermatitis as DLT, and other toxicity is mild.
Chen
Ming
M
Department of Radiation Oncology, Cancer Center, Sun Yat-Sen University, Guangzhou, China.
Wu
Shao-Xiong
SX
Chen
Yuan-Yuan
YY
Lu
Li-Xia
LX
Bao
Yong
Y
Lin
Huan-Xin
HX
Xian
Chao-Gui
CG
Li
Qun
Q
Deng
Xiao-Wu
XW
Lu
Tai-Xiang
TX
Cui
Nian-Ji
NJ
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011882:Radiotherapy, High-Energy
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel