GP对比TP方案诱导化疗联合同步放化疗治疗西北非高发区局部晚期鼻咽癌的疗效分析--一项前瞻性单中心Ⅱ期临床研究

Comparison of GP and TP induction chemotherapy combined with concurrent radiochemotherapy for locally advanced nasopharyngeal carcinoma in the non-endemic of Northwest China:A prospective single center phaseⅡclinical study

目的为探讨GP方案诱导化疗联合同步放化疗对比TP方案诱导化疗联合同步放化疗方案治疗我国西北非高发区局部区域晚期鼻咽癌的疗效及毒副反应,开展了前瞻性、单中心、随机对照临床研究,以明确GP方案诱导化疗在局部区域晚期鼻咽癌治疗中的价值。方法本中心初诊初治、病理确诊鼻咽癌、临床分期Ⅲ~Ⅳb期的患者随机分配至GP方案诱导化疗联合同步放化疗组(试验组)及TP方案诱导化疗联合同步放化疗组(对照组)。诱导化疗给予2~3周期。顺铂同步化疗为每3周方案,放疗期间给予1~3周期。比较两组患者的肿瘤缩退、生存差异,并评价两种诱导化疗方案的毒性及顺应性。结果共72例患者纳入本研究,GP组34例,TP组38例。两组病例一般临床资料均衡可比。近期疗效评估,无论诱导化疗后亦或同期放化疗后,TP组鼻咽部病灶及颈部淋巴结ORR与GP组均无组间差异。全组中位随访时间74.8月(0.8~108.9月),GP组与TP组5年无远转生存率(DMFS)分别为83.9%、76.5%(χ^2=4.140,P=0.042)。在诱导化疗期间,GP组较之TP组,中性粒细胞减少、白细胞减少、血小板减少发生率较高(P<0.05),其他急性毒副反应及晚期毒副反应两组间无差异。结论在我国西北非高发区局部晚期鼻咽癌中,GP方案诱导化疗较之TP方案诱导化疗远期疗效获益;治疗期间GP方案组急性血液学毒性较TP组重,但经对症处理后未影响患者后续放化疗的顺应性,晚期毒性反应两组相当,治疗耐受性可。

Objective To explore the curative effect and adverse reactions of GP induction chemotherapy combined with chemoradiation contrast TP induction for local advanced nasopharyngeal carcinoma in the non-endemic of Northwest China,our center conducted the prospective,single-center,randomized controlled clinical research so as to clarify GP regimenvalue of induction chemotherapy in local advanced nasopharyngeal carcinoma treatment.Methods We randomly assigned patients with newly diagnosed stageⅢ-Ⅳb patients to GP regimen of induction chemotherapy in combination with concurrent chemoradiotherapy and TP.Induction chemotherapy was given 2-3 cycles.Cisplatin regimen chemotherapy was given every 3 weeks and 1-3 cycles during radiotherapy.We compared the differences in tumor shrinkage and survival between the two groups and evaluated the toxicity and compliance of the two induction chemotherapy regimens.Results A total of 72 patients were enrolled in this study,including 34 patients in GP group and 38 patients in TP group.The general clinical data of the two groups were balanced.Short-term efficacy evaluation showed no difference between the TP group and the GP group in terms of nasopharyngeal disease and ORR of cervical lymph nodes either after induction or concurrent chemoradiotherapy.The median follow-up time of the whole group was 74.8 months(0.8-108.9 months),and the 5-year DMFS of the GP group and the TP group was 83.9%and 76.5%(χ^2=4.140,P=0.042),respectively.The difference was statistically significant.During the induction chemotherapy,the incidence of neutropenia,leukopenia and thrombocytopenia in the GP group was higher than that in the TP group(P<0.05).There was no difference between the two groups in other acute or late toxic or side effects.Conclusion In local advanced nasopharyngeal carcinoma in non-endemic regions of Northwest China,long-term efficacy of GP chemotherapy is better than that of TP chemotherapy.During the treatment,acute hematological toxicity of GP regimen group was heavier than that of TP group,but the compliance of subsequent chemoradiotherapy was not affected after symptomatic treatment.The late toxicity was equivalent to that of the two groups,and the treatment tolerance was acceptable.