紫杉醇同步后程加速超分割方案治疗老年食管癌的近期疗效

Short-term Efficacy of Paclitaxel Plus Concurrent Late-course Accelerated Hyperfractionated Radiotherapy on Elderly Patients with Esophageal Carcinoma

目的探讨老年食管癌后程加速超分割放射治疗加国产紫杉醇同步化疗的近期疗效及不良反应。方法 88例老年食管癌患者随机分为放化组（后程加速超分割放疗同步紫杉醇化疗组）44例和单放组（单纯后程加速超分割放疗组）44例。单放组先常规分割放疗2Gy/d,5Fx/W,36Gy/18Fx后改为2Fx/d,间隔〉6h,（1.4~1.5）Gy/Fx,总剂量（DT）（61.2~66）Gy/（36~38）Fx;放化组照射方法和剂量完全同单放组,放疗开始予紫杉醇同步化疗,30mg/m2静脉滴注3h,放疗前给药,每周1次,共6次,用药前给予预处理。观察指标主要包括近期疗效、1年局控率、1年生存率、食管和气管的近期急性反应、血液系统不良反应、胃肠反应等。结果放化组总有效率（CR＋PR）为93.2%;单放组总有效率为77.3%,两组间总有效率差异具有统计学意义（χ2=4.423,P〈0.05）。放化组和单放组1年局控率分别为86.4%和72.7%;1年生存率分别为86.4%和72.7%,两组间差异具有统计学意义（P〈0.05）。两组急性食管炎、气管炎、胃肠道反应等发生率差异均无统计学意义（P〉0.05）。放化组血液系统毒性增加,Ⅲ~Ⅳ度骨髓抑制两组差异具有统计学意义（P〈0.01）。结论后程加速超分割放射治疗加紫杉醇同步化疗治疗老年食管癌是一种可以耐受的方案,近期疗效有改善,远期疗效值得进一步研究。

Objective To evaluate the short-term efficacy and clinical toxicity of late-course accelerated hyperfractionated radiotherapy plus concurrent chemotherapy with China-made paclitaxel in treatment of elderly patients with esophageal carcinoma.Methods From Nov.2006 to Nov.2008,88 elder patients with esophageal carcinoma were randomly divided into two groups：44 cases in the LCAF group receiving LCAF alone;another 44 cases in the LCAF＋C group with additional paclitaxel 30 mg/m2,once per week before radiotherapy for six weeks with premedication of one hour travenous infusion simultaneously.All patients were beforehand laid immobilized with thermoplastic cast.Six MV X-ray or fifteen MV X-ray was employed.The schedule of LCAF was as following： conventional radiotherapy of 2.0 Gy per day,once per day,five days per week,was treated during the first phase to a total dose of 36 Gy,then followed by LCAF（twice per day,1.4~1.5 Gy per fraction,between two fractions more than six hours,to the total dose of 61.2~66 Gy with 36-38 fractions）.The toxicity,response rate,one-year local control rate and one-year overall survival rate were evaluated and compared between the two groups.Results The total response rate（CR＋PR） in the LCAF＋C group and in the LCAF group was 93.2% and 77.3%,respectively.There was a significant difference（χ2=4.423,0.01P0.05）of the total response rate between the two groups.The one-year local control rates and the one-year survival rates were 86.4%,72.7% and 86.4%,72.7% respectively,whose difference was statistically significant（P0.05）.Acute radiation esophagitis grade 1~2 and grade 3~4 for the two groups were 68%,61% and 25.0%,22.7%,respectively.Acute radiation pneumonitis grade 1~2 and grade 3~4 for those of the two groups were 29.5%（13/44）,31.8% and 9.1%,4.5%,respectively.No significant diferences in incidences of acute radiation pneumonitis and esophagitis between LCAF＋C and LCAF groups were found（P0.05）,The rate grade 3-4 myelosuppression in LCAF＋C was significantly higher than in LCAF（P0.01）.All the toxicities were well tolerated.Conclusion The toxicity of hyperfractionated radiotherapy delivered concurrently with China-made paclitaxel regimen for elder patients with esophageal cancer is tolerable and the improved short-term effect is promising.But the long-term effect is worth further study.