放射治疗同步紫杉醇化疗局部晚期非小细胞肺癌的Ⅱ期临床研究  

Phase Ⅱ study on concomitant paclitaxel and radiotherapy for loc ally advanced non-small cell lung cancer

作　　者：吕纪马[1] 王绿化[1] 周宗玫[1] 张红星[1] 陈东福[1] 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤研究所肿瘤医院放射治疗科,北京100021

出　　处：《中华放射肿瘤学杂志》2004年第2期89-92,共4页Chinese Journal of Radiation Oncology

摘　　要：目的　评价放射治疗同步紫杉醇化疗 (1次 /周 )局部晚期非小细胞肺癌的毒性和近期疗效。方法　 18例局部晚期非小细胞肺癌患者卡氏评分≥ 80 ,中位年龄 6 4岁 (36～ 73岁 ,3例≥ 70岁 ) ;男性 15例 ,女性 3例 ;鳞癌 8例 ,腺癌 7例 ,分化差的癌 3例 ;ⅢA期 4例 ,ⅢB期 14例。放射治疗采用 6～ 8MV加速器 ,常规分割 ,总剂量 6 0～ 70Gy ;紫杉醇 6 0mg(14例 )或 90mg(2 8～ 4 6mg/m2 )每星期一放射治疗前给药 1次 ,共 5次 ,用药前给予预处理。按WHO疗效及毒性标准评价治疗毒性和疗效 ,以Kaplan Meier法计算生存率并绘制生存曲线。结果　全组中位随访 2 8个月 (4～ 35个月 ) ,无超敏反应。治疗毒性反应包括放射性食管炎 13例 (1级 4例 ,2级 4例 ,3级 5例 ) ;放射性肺炎 8例 (2、3级各 4例 ) ;1级发热 3例 ;1级皮肤反应 2例 ;1级恶心和 1、2级外周神经毒性各 1例 ;白细胞减少 6例(1级 3例 ,2级 2例 ,3级 1例 ) ;血小板减少 4例 (1级 3例 ,2级 1例 ) ;贫血 7例 (1级 6例 ,2级 1例 )。完全缓解 (CR) 1/ 15 ,部分缓解 (PR) 10 / 15 ,稳定 (SD) 2 / 15 ,进展 (PD) 2 / 15 ,总有效 (CR +PR) 11/ 15 ,中位生存期 18个月 (95 %CI 12 .3～ 2 3.7个月 ) ,1、2年生存率分别为 6 4 .3%和 30 .2 %。结论　放射治疗同步紫?Objective To evaluate the clinical toxicity and effect of concurrent paclitaxel chemotherapy and radiation therapy for locally advanced non-small cell lung cancer.Methods From April 1999 to September 2001,18 patients were allotted to this clinical phase Ⅱ study. Of 18 patients ,there were 15 males and 3 females, with a median age of 64 years (rang 36 to 73). Karnofsky scores were ≥ 80 for all cases. Four patients who had clinical stage ⅢA and 14 ⅢB lesions. Eight patients were proven as having squamous carcinoma, 7 adenocarcinoma and 3 poorly-differentiated carcinoma. Paclitaxel with a dose intensity rang of 28-46?mg/m 2 - diluted with 500 ml saline was weekly administrated once per week before radiotherapy for 5 weeks with premedication of 3-hour intravenous infusion. Conventional radiotherapy was delivered to the primary lesion,ipsilateral hilum, relevant mediastinum and bilateral supraclavicular regions to a total dose of 60-70 Gy by 6-8 MV photon. Toxicities and effects were evaluated according to the criteria of WHO. The survival rate was calculated and the survival cruve was plotted by Kaplan-Meier.Results Fifteen patients were evaluable for the toxicities and effects. Grade 3 radiation-esophagitis, pneumonia and leukocytopenia were observed in 5,4 and 1 patient, respectively. The overall responce rate (CR+PR) was 73.3% and median survival time was 18 months (95% CI 12.3-23.7 months). The 1-year and 2-year survival rates were 64.3% and 30.2%,respectively, after a median follow-up of 28 months (rang 4-35 months). Conclusions The toxicites of weekly paclitaxel of 28- 38?mg/m 2 combined with concurrent radiation therapy for advanced non-small cell lung cancer is tolerable and the improved responce rate and median survival time are promising.

关 键 词：放射治疗 紫杉醇 化疗 晚期非小细胞肺癌 预后 

分 类 号：R734.2[医药卫生—肿瘤]