局部晚期鼻咽癌吉西他滨和顺铂联合调强放疗Ⅱ期临床试验  

Phase H study of gemcitabine plus cisplatin chemotherapy combined with intensity modulatedradiotherapy in locoregionally advanced nasopharyngeal carcinoma

作　　者：欧丹[1] 何霞云[1] 胡超苏[1] 应红梅[1] 朱国培[1] 

机构地区：[1]复旦大学上海医学院肿瘤学系复旦大学附属肿瘤医院放疗科,上海200032

出　　处：《中华放射肿瘤学杂志》2012年第5期412-415,共4页Chinese Journal of Radiation Oncology

摘　　要：目的评价吉西他滨和顺铂与调强放疗序贯治疗局部晚期鼻咽癌的疗效和不良反应。方法71例局部晚期鼻咽癌（Ⅲ期41例、ⅣA期30例）患者接受新辅助化疗、调强放疗、辅助化疗，新辅助化疗、辅助化疗各2个疗程[吉西他滨1000mg／m^2，第1、8天静脉滴注（＞30min）；顺铂25mg／m^2，第1～3天，静脉滴注；21d为1个疗程]。调强放疗鼻咽大体肿瘤体积66．0～70．4Gy，颈部淋巴结大体肿瘤体积66Gy，临床高危靶体积60Gy，临床低危靶体积54Gy。结果新辅助化疗后的有效率为91．2％，主要急性不良反应为1～2级骨髓抑制。所有患者随访满3年，3年鼻咽局部控制率、区域控制率、无远处转移率、总生存率分别为93％、99％、91％、90％。3级晚期不良反应中张口困难1例、听力下降2例、颅神经损伤2例。结论吉西他滨和顺铂联合调强放疗局部晚期鼻咽癌有效、方便、耐受性良好，值得进一步探索药物最适当的治疗周期。Objective To evaluate the efficacy and toxicity of gemcitabine plus cisplatin （GP） chemotherapy combined with intensity-modulated radiation therapy （IMRT） in locoregionally advanced nasopharyngeal carcinoma （NPC）. Methods 71 patients （Stage Ⅲ ：41, Stage ⅣA ：30） with locoregionally advanced NPC were entered this study. Neoadjuvant chemotherapy was consisted of cisplatin 25 mg/m2 intravenously on dl-3 and gemeitabine 1000 mg/m2 in 30 minutes intravenous infusion on days 1 and 8, every 3 weeks for 2 cycles. Adjuvant chemotherapy consisted of 2 cycles of the same GP regimen was given at 28 days after the end of radiotherapy. The prescription doses was 66. 0 -70. 4 Gy to the gross tumor volume, 66 Gy to positive neck nodes, 60 Gy to the high-tisk clinical target volume, 54 Gy to the low-risk clinical target volume. Results The overall response rate to neoadjuvant chemotherapy was 91.2% , acute toxicity was mainly grade 1 -2 myleosuppression. All patients completed IMRT. The median follow-up duration was 38 months. The 3-year nasopharyngeal local control, regional control, distant metastasis-free survival rate and overall survival rate were 93%, 99%, 91% , 90%, respectively. Severe late toxicities included grade 3 trismus in 1 patient, grade 3 heating impairment in 2 patients and cranial nerve palsy in 2 patients, respectively. No grade 4 late toxicities were observed. Conclusions The combination of GP chemotherapy and IMRT for locoregionally advanced nasopharyngeal carcinoma is well-tolerated, convenient, effective, and warrants further studies of more proper cycles of GP regimen.

关 键 词：鼻咽肿瘤/化学疗法 鼻咽肿瘤/放射疗法 化学疗法 吉西他滨和顺铂 放射疗法 调强 预后 

分 类 号：R739.63[医药卫生—肿瘤]