恩度联合化疗治疗转移性鼻咽癌的Ⅱ期临床研究

A Phase- II Clinical Study on Endostar in Combination with Chemotherapy for Metastatic Nasopharyngeal Carcinoma

目的:评估恩度联合化疗治疗转移性鼻咽癌的近期疗效和安全性。方法:对30例影像学、细胞学或病理诊断转移性鼻咽癌患者进行化疗,初治患者采用顺铂+氟尿嘧啶方案,非初治患者采用吉西他滨+顺铂方案,化疗同时给予恩度1次/d,静滴,共14d。治疗期间监测血常规、生化、尿常规、血压、心电图等指标,化疗1次/3周,第2个疗程化疗后4周评估近期疗效并进行统计分析。疗效评估参照RECIST标准,主要不良反应评估参照美国国立癌症中心的常见毒性标准(NCI-CTC-AE 3.0版)。结果:30例患者均完成治疗,其中CR 4例,PR 22例,SD 3例,PD 1例,临床获益率96.7%,客观反应率86.7%。3级以上不良反应主要有粒细胞减少、血小板降低和1例左心室舒张功能不全。所有患者经相应治疗后不良反应均得到缓解。结论:恩度联合化疗治疗转移性鼻咽癌近期疗效和耐受性良好。值得进一步开展临床研究评估生存受益。

Objective： This work aimed to evaluate the efficiency and acute toxicities of recombinant human endostatin （Endostar） combined with chemotherapy in metastatic nasopharyngeal carcinoma （NPC）. Methods： Thirty metastatic NPC patients were treated with Endostar in combination with chemotherapy. The chemotherapeutic regimen consisted of cisplatin and fluorouracil, or cisplatin and gemcitabine. Endastar was intravenously given at a dosage of 7.5 mg. m-2. day-1 for 14 days. The treatment outcomes were evaluated according to the RESIST criteria. The National Cancer Institute - Common Toxicity Criteria - AE3.0 （NCI-CTC-AE 3.0） was used to evaluate the acute toxicities. Results： All 30 patients completed the plan. Among them, complete remission was found in 4 patients, partial remission in 22, stable disease in 3, and progressed disease in 1. Adverse events Grade 3 and above included granulocytopenia and thrombocytopenia. Left ventricular diastolic dysfunction occurred in 1 patient. All adverse events were treated and relieved. Conclusion： Endostar combined with chemotherapy was efficient and safe for metastatic NPC. Further studies are needed to verify the long-term effects.