局部晚期鼻咽癌患者尼妥珠单抗及塞来昔布联合放化疗临床观察

Nimotuzumab and celecoxib combined with chemoradiotherapy for locally advanced nasopharyngeal carcinoma

目的放疗为主的综合治疗是鼻咽癌的主要治疗手段,分子靶向治疗是近年研究的热点。本研究旨在评价诱导化疗序贯调强放疗同期联合尼妥珠单抗及塞来昔布,治疗局部晚期鼻咽癌的疗效及不良反应。方法选取2013-06-01-2016-09-30江南大学附属医院就诊的31例局部晚期鼻咽癌患者,放疗前给予2个周期诱导化疗,采用IMRT技术,放疗同期给予尼妥珠单抗及塞来昔布治疗。根据RTOG评分标准评价放疗不良反应,NCI CTCAE 3.0标准评价化疗不良反应,RECIST实体瘤评价标准评价客观疗效。中位随访时间为30.5个月。采用Kaplan-Meier法绘制生存曲线。结果放疗结束后3个月客观有效率100%。2年无进展生存率89.2%,95%CI为75.8%～98.5%,2年总生存率96.8%,95%CI为84.1%～100%。放疗期间不良反应3～4度发生率38.7%(12/13),其中口腔黏膜炎3～4度发生率25.8%(8/31),中性粒细胞减少3度发生率12.9%(4/31)。所有患者均未出现尼妥珠单抗相关的皮疹、腹泻、过敏反应及塞来昔布相关的心血管不良反应。结论诱导化疗序贯IMRT联合尼妥珠单抗及塞来昔布治疗局部晚期鼻咽癌耐受性良好,初步疗效满意,值得临床进一步研究。

OBJECTIVE Radiotherapy is the primary treatment modality for nasopharyngeal carcinoma.Newer treatment modalities,especially the use of molecular targeted agents concurrently with radiotherapy are explored.This study aimed to evaluate the safety and efficacy of induction chemotherapy followed by intensity-modulated radiotherapy plus concurrent nimotuzumab and celecoxib for patients with locally advanced nasopharyngeal carcinoma (LA-NPC). METHODS A total of 31 newly diagnosed patients with LA-NPC treated at affiliated hospital of Jiangnan University between June I 2013 and September 30 2016 were analyzed.All patients were treated with the regimen of two cycles of induction chemotherapy,followed by intensity-modulated radiotherapy plus concurrent nimotuzumab and celecoxib.Chemotherapy toxicities were graded by the National Cancer Institute Common Toxicity Criteria(NCI CTCAE,version 3.0), whereas radiotherapy-related toxicities were assessed using the Acute and Late Radiation Morbidity Scoring Criteria of RTOG.The evaluation of disease response was according to the Response Evaluation Criteria in Solid Tumors(RECIST). With a median follow-up of 30.5 months,Survival curve was estimated with the Kaplan-Meier method.RESULTS Objective response rate(ORR)was 100%at three months after the completion of IMRT.the 2-year PFS and OS were 89.2% (95 %CI:75.8%-98.5%)and 96.8 %(95%CI:84.1%-100 %).During the period of radiotherapy,grade 3-4 toxicities occurred in 38.7%(12/31)patients:25.8%(8/31)had grade 3 oral'mucositis,12.9%(4/31)had grade 3 neutropenia. CONCLUSIONS The regime of induction chemotherapy followed by intensity-modulated radiotherapy plus concurrent nimotuzumab and celecoxib for the treatment of LA-NPC is well-tolerated,with encouraging preliminary clinical outcome. Further clinical trials are needed to confirm these findings.