放疗联合促红细胞生产素治疗相对贫血鼻咽癌患者的随机分组研究  

Prospective Randomized Clinical Trial on Radiotherapy with or without Recombinant Human Erythropoietin for Anemic Patients with Nasopharyngeal Carcinoma

作　　者：李金高[1] 龚晓昌[1] 叶新芊[1] 袁霞[1] 肖芸[1] 敖帆[1] 

机构地区：[1]江西省肿瘤医院放疗科,330029

出　　处：《实用癌症杂志》2010年第1期45-48,共4页The Practical Journal of Cancer

摘　　要：目的探讨放射治疗联合重组人促红细胞生成素(rHu-EPO)治疗贫血鼻咽癌的疗效。方法将放疗前血红蛋白<130g/L的104鼻咽癌患者,随机分为放疗组(50例)和放疗联合rHu-EPO组(54例)。两组放疗剂量为70Gy,联合治疗组在放疗第1天开始皮下注射rHu-EPO,每次10000IU,每周3次,治疗第3周开始两组患者均每日口服硫酸亚铁300mg。结果全组中位随访时间47个月。全组患者3、4、5年总生存率为77.9%、74.1%、70.0%,联合治疗组和放疗组的3、4、5年总生存率分别为75.4%、72.6%、69.4%和80.3%、75.5%、71.9%,联合治疗组和放疗组总生存率差异无统计学意义。全组3、4、5年无进展生存率为64.3%、63.2%和57.9%,联合治疗组和放疗组3、4、5年无进展生存率分别为58.8%、58.8%、56.1%和70.4%、68.1%、60.7%,两组无进展生存率差异无统计学意义。全组5年局部复发率为11.5%,远处转移率为24.0%,其中联合治疗组和放疗组复发率分别为14.8%和8.0%,远处转移率分别为22.2%和26.0%,差异无统计学意义。结论放疗联合rHu-EPO未能提高鼻咽癌患者放疗疗效。Objective To determine whether the addition of recombinant human erythropoietin （rHu-EPO） couht improve the outcomes of anemic patients reeeiving definitive radiotherapy for nasopharyngeal carcinoma. Methods Eligible patients were randomized to receive either radiotherapy combined with rHu-EPO or radiotherapy alone. The patients must have poorly differentiated squamous cell carcinoma with pre-radiotherapy hemoglohin less than 130g/L. The radiotherapy dose was 70Gy in 7 weeks,with a boost dose of 6 to 10Gy in 3 to 5 fractions if residual disease existed at the end of the radiotherapy. From the first day of radiotherapy,patients randomized to rHu-EPO group received rHu-EPO 10000U three times every week. Patients in both groups also received ferrous sulfate,300mg each day,after two weeks of radiotherapy. Results A total of 104 patients were enrolled. Median follow-up was 47 months. The 3,4,5 year overall survival for the 104 patients was 77.9% ,74.1% and 70.0% ,respectively. The 3,4,5 year overall survival were 75.4% ,72.6% and 69.4% for the rHu-EPO group,and 80.3% ,75.5% and 71.9% for the radiotherapy alone group. The overall survival in the two groups was not signiticantly different. The 3,4,5 year progression free survival for the 104 patients was 64.3% ,63.2% and 57.9% ,respectively. The 3,4,5 year progression free survival was 58.8% ,58.8% and 56.1% for rHu-EPO group,and 70.4% ,68.1% and 60.7% for the radiotherapy alone group. Again, the progression free survival in the two groups was not significantly different. The 5 year loco-regional recurrent rate was 11.5% , with 14.8% in the rHu-EPO group and 8.0% in the radiotherapy group. The 5 year distant metastasis rate was 24.0% for the whole group,with 22.2% in the rHu-EPO group and 26.0% in the radiotherapy group. The Ioco-regional recurrent rate and distant metastasis rate were not significantly different for the two groups. Conclusion The addition of rHu-EPO to definitive radiotherapy does not improve outcomes for patients with nasophaungeal carcinoma.

关 键 词：鼻咽肿瘤 放射疗法 贫血 重组人促红细胞生成素 

分 类 号：R739.63[医药卫生—肿瘤]