PhaseⅡclinical trial of induction chrono-chemotherapy followed by concurrent chemoradiation in loco-regionally advanced nasopharyngeal carcinoma / 中国肿瘤临床

ABSTRACT

Objective:The present study aimed to investigate the short-term efficacy and adverse effects of induction chrono-che-motherapy including docetaxe1 (TXT), cisplatin (DDP), and 5 fluorouraci1 (5-FU) followed by concomitant chemoradiotherapy in lo-co-regionally advanced nasopharyngeal carcinoma (NPC). Methods:Newly diagnosed locally advanced (Ⅲ~Ⅳb) NPC patients were enrolled in this study. All patients received three cycles of TPF regimen. The TPF chemotherapy regimen was administered as followsTXT, 75 mg/m2, i.v. infusion, d1; DDP, 75 mg/m2, bolus infusion from 1000 to 2200, d1-5; and 5-FU 750 mg/m2/d bolus infusion from 2200 to 1000, d1-5, with 21 days each cycle, followed by concomitant IMRT and chemotherapy (paclitaxel 135 mg/m2 i.v. infu-sion, with 21 days each cycle and a total of 2 courses). Acute and late toxicities were graded according to the Common Terminology Cri-teria for Adverse Events v3.0 scoring criteria. Tumor response was evaluated using 2000 Response Evaluation Criteria in Solid Tumors criteria. Results:The CR and PR rates of induction chemotherapy were 23.8%and 68.6%, respectively;whereas the CR and PR rates of the combined modality treatment were 64.8%and 31.4%, respectively. Two-year overall survival rate was 91.4%, two-year progres-sion free survival rate was 87.0%, and two-year distant metastasis-free survival rate was 88.4%. The main side effects from induction chemotherapy include an over grade 3 granulocytopenia of 28.6%. Major toxicity from concurrent chemo-radiotherapy was oral mucosi-tis (81.0%);grade 3 to 4 oral mucositis was 16%. No treatment-related deaths occurred in this study. Conclusion:Induction chrono-che-motherapy using TPF followed by concurrent chemoradiotherapy of paclitaxel is a well-tolerated treatment with short-term efficacy and severity for locally advanced NPC. Further follow-up is required to assess the late effects and long-term efficacy.