Multi-center Clinical Study of Nimotuzumab Combined with PF Regimen in Induction Treatment of Locally Advanced Nasopharyngeal Carcinoma

Objective To investigate the safety and efficacy of the induction therapy of nimotuzumab combined with PF regimen (cisplatin+5-fluorouracil) in the follow-up treatment of locally advanced nasopharyngeal carcinoma patients received concurrent chemoradiotherapy.

Methods We included 118 patients with stage Ⅲ-Ⅳa nasopharyngeal carcinoma, 58 cases in NPF group (induction therapy of nimotuzumab combined with PF regimen) and 60 cases in TPF group (induction chemotherapy of docetaxel, cisplatin and fluorouracil regimen). After two cycles of induction therapy, all patients received concurrent cisplatin and intensity-modulated radiotherapy (IMRT), and the safety and short-term efficacy of the two groups were compared.

Results Compared with TPF group, NPF induction therapy was more effective for cervical lymph nodes (P=0.036); however, there was no significant difference in the effect of induction therapy on primary lesions, overall effect or the immediate effect of the whole course of treatment(P > 0.05). Compared with TPF group, neutropenia and gastrointestinal reaction in the NPF group was significantly improved during the induction therapy (P=0.028, P=0.049); gastrointestinal reaction, oral mucositis and radiation dermatitis in the NPF group were significantly improved during the concurrent chemoradiotherapy (P=0.038, P=0.041, P=0.035).

Conclusion For locally advanced nasopharyngeal carcinoma patients received cisplatin concurrent IMRT, the induction therapy of nimotuzumab combined with PF regimen have a better lymph node remission rate and mild adverse reactions. Patients had better tolerance in subsequent concurrent chemoradiotherapy, but the long-term efficacy requires further follow-up observation.