3D-CRT结合同步化疗治疗Ⅲ期非小细胞肺癌的随机分组研究

目的]研究三维适形放射治疗（3D-CRT）大剂量分割同步给予铂类为主的化学药物治疗不能切除的Ⅲ期非小细胞肺癌（NSCLC）的可行性。方法]自2000年8月至2003年6月，将90例符合入选条件的Ⅲ期非小细胞肺癌患者随机分为3组，1组30例，以铂类为主的化疗＋3D-CRT常规分割组；2组30例，为单纯3D-CRT常规分割组；3组30例，以铂类为主的化疗＋3D-CRT大剂量分割组。1、2组分割剂量1．8—2Gy／次，5次/周，总剂量66～66．6Gy／6～8周，3组4．5～5Gy／次，3次/周，总剂量45Gy／4～5周.结果]1、2、3组的3年总生存率和无病生存率分别为33.3％、20．0％、36．6％和23.3％、16．6％、23．3％，中位生存期分别为31、20、32个月。1、3组明显好于2组（1组和2组比较．Х^2=3．87．P=0．0492；2组和3组比较，Х^2=4．28．P=0．0387）．2组的中位转移时间为22个月，与1组的31．5个月、3组的30．5个月比较，有显著性统计学意义（1组和2组比较Х^2=4．71，P=0．0301；2、3组比较Х^2=4．02，P=0．0449）。1、2、3组的中位复发时间分别为27．5、32、28个月，无显著性统计学差异（1、2组比较Х^2=0．42，P=0．5177；1、3组比较Х^2=0．001，P=0．9636；2、3组比较Х^2=0．44，P=0．5066）。急性放射性食管炎：1、2、3组的发生半分别为46．7％、43．3％、63．3％。1、2、3组发生放射性肺炎的例数接近（Х^2=1．440，P=0．487），以Ⅰ级反应为主。结论]3D-CRT联合化疗降低了Ⅲ期非小细胞肺癌患者的远处转移率，提高了总生存率和无病生存率。大剂量分割结合同步化疗可缩短疗程．提高局部控制率．但发生早期和晚期放射性损伤的概率增加．

Concurrent Three-Dimensional Conformal Radiotherapy Combined with Systemic Chemotherapy for Stage Ⅲ Nonsmall Cell Lung Cancer:A Randomized Trial

Purpose] To investigate the feasibility of conventional-dose fractionation, hypofractionation three-dimensional conformal radiotherapy （3D-CRT） plus concurrent cisplatin-based systemic chemotherapy on the patients with unresectable stage Ⅲ non-small cell lung cancer （NSCLC）. Methods ] Ninety cases with unresectablc stage Ⅲ NSCLC from August 2000 to June 2003 were divided randomly into 3 groups （30 cases each group）： group 1, conventional-dose fractionation 3D-CRT plus concurrent cisplatin-based systemic chemotherapy; group 2, conventional-dose fractionation 3D-CRT alone; group 3, hypofractionation 3D-CRT plus concurrent cisplatin-based systemic chemotherapy. Conventional-dose fractionation schedule 3D-CRT was given to a total dose of 66-66.6Gy （1.8-2Gy/fraction, 5 fractions/week） and hypofractionation schedule was given to a total dose of 45Gy （4.5-5Gy/fraction, 3 fractions/week）. Results] The 3-year overall survival rate and disease-free survival rate in Group 1, Group 2 and Group 3 were 33.3%,20.0%, 36.6% and 23.3%,16.6%,23.3% respectively. The median survival was 31 months, 20 months and 32 months, respectively, with superior outcome in group 1 and group 3 compared to group 2 （group 1 vs. group 2：Х^2=3.87 ,P=0.0492 ;group 2 vs. group 3： Х^2=4.28,P=0.0387）. The median metastasis time in group 2 （22 months） was lower than that in group 1 （31.5 months） and group 3 （30.5 months） （group 1 vs. group 2： Х^2=4.71, P=0.0301 ;group 2 vs. group 3： Х^2=4.02,P=0.0449）. The median recurrent time of group 1, group 2 and group 3 was 27.5, 32 and 28 months, respectively. There was no significant difference in regional recurrence among three groups （group 1 vs. group 2： Х^2=0.42,P=0.5177;group 1 vs. group 3： Х^2= 0.001, P=0.9636;group 2 vs. group 3： Х^2=0.44,P=0.5066）. The incidence of radiation-induced esophagitis in these 3 groups was 46.7%, 43.3% and 63.3%, respectively. The number of radiation-induced pneumonitis patients in these 3 groups was similar