尼妥珠单抗联合PF方案诱导治疗局部晚期鼻咽癌的多中心临床研究

陆颖; 陈达桂; 梁锦辉; 高健全; 罗展雄; 王仁生; 刘文其; 黄昌杰; 宁雪坚; 刘美莲; 黄海欣

doi:10.3971/j.issn.1000-8578.2019.18.2031

尼妥珠单抗联合PF方案诱导治疗局部晚期鼻咽癌的多中心临床研究

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

摘要

摘要:
目的探讨尼妥珠单抗联合PF方案（顺铂+氟尿嘧啶）的诱导治疗在后续接受同期放化疗的局部晚期鼻咽癌患者中的安全性及作用。
方法 118例Ⅲ~Ⅳa期鼻咽癌患者纳入研究，随机分为NPF组58例（尼妥珠单抗联合PF方案诱导治疗组）和TPF组60例（多西他赛、顺铂、氟尿嘧啶方案诱导化疗组），2周期诱导治疗后，所有患者均接受顺铂同期的调强放射治疗（IMRT），比较两组的安全性、近期疗效。
结果与TPF组比较，NPF组诱导治疗对于颈部淋巴结有更显著的疗效（P=0.036）；而诱导治疗的原发病灶疗效、诱导治疗的总体疗效和全程治疗结束的即刻疗效评价比较，差异均无统计学意义（P > 0.05）。诱导治疗期间，中性粒细胞减少、胃肠道反应较TPF组均显著改善（P=0.028, P=0.049）。同期放化疗阶段，与TPF组比较，NPF组的胃肠道反应、口腔黏膜炎及放射性皮炎均显著改善（P=0.038, P=0.041, P=0.035）。
结论对于后续接受顺铂同期IMRT治疗的局部晚期鼻咽癌，尼妥珠单抗联合PF方案的诱导治疗具有更好的淋巴结缓解率，且不良反应更轻微；患者在后续的同期放化疗中耐受性更好，但远期疗效需要进一步随访观察。

Abstract:
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.

HTML全文

参考文献(12)

施引文献

资源附件(0)