同步低剂量奈达铂联合超分割放疗治疗局部晚期非小细胞肺癌的临床Ⅰ/Ⅱ期研究  

The low-dose nedaplatin combined with hyperfractionate radiotherapy: a phrase Ⅰ/Ⅱ trial for locally advanced non-small cell lung cancer

作　　者：林玉成[1] 王建化[1] 王玉斌[1] 傅益谋[1] 陈文俊[1] 

机构地区：[1]瑞安市人民医院放疗科,浙江瑞安325200

出　　处：《中国癌症杂志》2010年第12期934-937,共4页China Oncology

摘　　要：背景与目的:同步联合放化疗是局部晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的标准治疗模式,并且同步低剂量化疗较高剂量化疗毒性更低、生存优势更好;超分割放疗较常规放疗更能提高局部控制率。本研究比较同步每周低剂量奈达铂联合超分割放疗与常规分割放疗的即期疗效和不良反应,旨在观察超分割放疗是否较常规放疗更具优势。方法:选择2008年4月—2010年4月我院62例不可手术的T4和(或)N2期NSCLC患者(恶性胸水除外),KPS评分>70,均经病理确诊,无远处转移。采用信封法随机分为超分割组32例和常规分割组30例。超分割组采用超分割放疗,剂量为6周69.6 Gy/58 f;常规分割组采用常规分割放疗,剂量为6周60 Gy/30 f。两组均同步低剂量奈达铂化疗,15～20 mg/m2,与每周一放疗前半小时静脉给药。3个月复查后电话随访,采用χ2检验对有效率和不良反应发生率进行比较,Kaplan-meier法计算生存率。结果:总随访率100%。随访时间4～24个月,中位随访时间9.3个月。超分割组、常规分割组有效率分别为84.4%和76.6%(χ2=0.08,P=0.792);1年生存率分别为69.4%和62.7%(χ2=1.41,P=0.230)。两组Ⅰ～Ⅱ级急性放射性支气管炎发生率分别为59.4%和80.0%,Ⅲ级为37.5%和20.0%;Ⅰ～Ⅱ级急性放射性肺炎发生率分别为96.9%和100%,Ⅲ级为3.1%和0%;Ⅰ～Ⅱ级急性放射性食管炎发生率分别为59.4%和83.3%,Ⅲ级为34.4%和16.7%;Ⅰ～Ⅱ级急性骨髓抑制分别为25.0%和20.0%,Ⅲ级为15.6%和13.3%。统计结果显示,两组间Ⅲ级急性放射性食管炎和Ⅲ级急性放射性支气管炎的发生率,两组差异有统计学意义(P<0.05)。结论:超分割放疗组即期疗效、1年生存率与常规分割放疗组相似。Ⅲ级急性放射性食管炎、Ⅲ级急性放射性支气管炎发生率高于常规分割放疗组,虽然可以耐受,但疗效并没有优势。Background and purpose：Presently,concurrent chemoradiotherapy is the standard treatment for the locally advanced non-small cell lung cancer（NSCLC）.Evidence showed that combined low-dose chemotherapy yielded lower toxicities and a better survival rate.Hyperfractionate radiotherapy could improve the local control rate.This study evaluated the superiority of the low dose of nedaplatin combined hyperfractionate radiotherapy in comparison to the combined conventional fractionation in terms of effectiveness and toxicity.Methods：Sixty two cases of unresectable NSCLC from T4（except malignant pleural effusion） and/or N2 patients who have a Karnofsky performance（KPS） score of 70,a definite pathological diagnosis and no metastasis,were randomly divided into the treatment-group（32 cases） or control-group（30 cases）.The radio-dosage for the treatment-group was 69.6 Gy/58 fractions（6 weeks） whereas that of the control-group was 60 Gy/30 fractions（6 weeks）.Both regimens were combined with 15-20 mg/m2 of nedaplatin and given half an hour before radiotherapy every week.Results：The foll ow-uprate was 100%,the follow-up time from 4 to 24 months（the median time was 9.3 months）.The response rate（RR） of the treatment-group and control-group were 84.4% and 76.6%,respectively（χ2=0.08,P=0.792）.1-year survival rates were 69.4% and 62.7%,respectively（χ2=1.41,P=0.230）.Low-grade（Ⅰ-Ⅱ） toxicity for the radiation of bronchitis in the two groups were 59.4% and 80.0%,respectively,but were 37.5% and 20.0%,respectively,for grade Ⅲ toxicity.Ⅰ-Ⅱ toxicity for radiation of esophagitis for the two groups were 59.4% and 83.3%,respectively,but 34.4% and 16.7%,respectively,for grade Ⅲ toxicity.Low-grade bone marrow suppression of the two groups were 25% and 20%,respectively,but 15.6% and 13.3%,respectively,for grade Ⅲ toxicity.All the toxicities of the two groups have no statistical significance respectively.Conclusion：There were no differences between the two groups in terms of RR and

关 键 词：非小细胞肺癌 超分割放疗 生存率 急性不良反应 

分 类 号：R734.2[医药卫生—肿瘤] R730.58[医药卫生—临床医学]