每周小剂量多西他赛同步适形放疗后DP巩固化疗治疗Ⅲ期非小细胞肺癌

Concurrent chemoradiotherapy with low-dose weekly docetaxel followed by consolidation chemotherapy with docetaxel and cisplatin in the treatment of stageⅢnon-small cell lung cancer

背景与目的同步放化疗是目前局部晚期非小细胞肺癌的标准治疗,但化疗药物的选择、剂量强度、放疗剂量及巩固化疗的作用仍没最终确定。本研究目的是比较多西他赛(Docetaxel,DTX)每周小剂量化疗与系统化疗同步适形放疗后DP方案巩固化疗对Ⅲ期非小细胞肺癌的疗效和毒副反应差异。方法44例初治的Ⅲ期非小细胞肺癌随机分为多西他赛每周小剂量化疗组(研究组)和系统化疗组(对照组)行同步放化疗。放疗采用三维适形累及野照射,常规分割,靶区总剂量66 Gy～70 Gy。放疗同时研究组给予DTX 20 mg.m^(-2).w^(-1)化疗,对照组给予DP方案(DTX 60 mg/m^2第1天+DDP 30 mg/m^2第1-3天,21天为一周期)化疗2周期。两组放疗结束后均给予DP方案化疗2-4周期。结果研究组和对照组的总有效率分别为81.8%、86.4%(x^2=0.120,P=0.942),完全缓解率均为27.3%,中位生存期分别为20个月和16个月,1、2年生存率分别为69.8%、48.1%和66.5%、40.2%,差异无统计学意义。3级以上白细胞减少和食管炎分别占患者的26.3%、14.3%和15.8%、28.6% (x^2=0.765,P=0.382;x^2=1.108,P=0.292),3级以上肺毒性少见。结论每周多西他赛同步适形放疗后多西他赛和顺铂巩固化疗治疗Ⅲ期非小细胞肺癌疗效较好,毒副反应可耐受。

Background and objective Concurrent chemoradiotherapy is regarded as the standard care for locally advanced non-small cell lung cancer at present. This paper is designed to evaluate the efficacy and toxicity of low-dose weekly docetaxel （DTX） with concurrent chemoradiotherapy followed by consolidation chemotherapy with DTX and cisplatin for unresectable stage Ⅲ non-small cell lung cancer（NSCLC）. Methods 44 previously untreated patients with stage Ⅲ NSCLC were randomized into low-dose weekly DTX group and control group concomitant with radiotherapy. Both groups were treated by the standard fractionation schedule with three-dimensional conformal radiotherapy. An involved-field irradiation technique was performed. Gross tumor and metastatic lymph nodes were irradiated to a total dose of 66 Gy-70 Gy. Patients in the former group received chemotherapy with DTX 20 mg.m^-2.w^-1, and the other group patients received DTX 60 mg/m^2 on day 1 and DDP 30 mg/m^2 on day 1-3 every 21 days. All patients received consolidation chemotherapy with DP regime after chemoradiotherapy for no more than 4 cycles. Results The overall response rates of patients in the low-dose weekly DTX group and control group were 81.8% with 27.3% CR（complete response） and 86.4% with 27.3% CR respectively （22=O.120, P=0.942）. After a median follow-up of 20 months, the median survival time was 20 months and 17 months respectively. The 1-, 2- year survival rates of patients in low-dose weekly DTX group and control group were 69.8%, 48.1% versus 66.5%, 40.2% respectively;there was no difference between two groups. Grade 3 or 4 neutropenia and esophagitis occurred in 26.3%, 14.3% and 15.8%, 28.6% respectively（x^2=0.765,P =0.382; 22=1.108,P =0.292）.Grade 3 and 4 pulmonary toxicity was unusual. Conclusion Concurrent chemoradiotherapy with low-dose weekly docetaxel followed by consolidation chemotherapy with docetaxel and cisplatin is highly active with manageable toxicity in patients with stage Ⅲ NSCLC.