紫杉醇联合奈达铂或顺铂周方案同步放化疗治疗Ⅲ期非小细胞肺癌的临床研究

The Research of Paclitaxel Weekly Combined with Nedaplatin or Cisplatin Concurrent with Radiotherapy and Chemotherapy for Advanced Ⅲ Non-small Cell Lung Cancer

目的观察每周小剂量紫杉醇联合奈达铂或顺铂同步放化疗治疗局部晚期非小细胞肺癌(NSCLC)的疗效及不良反应。方法 58例不能手术Ⅲ期非小细胞肺癌患者(Ⅲa期22例,Ⅲb期36例),随机分为观察组29例:接受紫杉醇45mg/m2 d1+奈达铂25 mg/m2 d1化疗,每周一次。对照组29例:接受紫杉醇45mg/m2 d1+顺铂25 mg/m2 d1化疗,每周一次。两组同期行肺部三维适形放疗(GTV:6600cGy/30f/6+w、CTV:6000 cGy/30F/6+w、PTV:5400 cGy/30F/6+w)。结果同步放化疗后评价疗效:观察组:CR1例;PR17例,总有效率(CR+PR)66.7%。对照组:CR0例;PR15例,总有效率(CR+PR)71.4%。χ2=0.02,P>0.05,两组比较差异无统计学意义。白细胞减少;贫血;肝功损害;放射性肺炎及放射性食道炎发生率两组比较差异亦无统计学意义(P>0.05)。肾功损害,恶心;呕吐及体质量下降>10%,发生率观察组明显低于对照组,两组比较差异均有统计学意义(P<0.05)。结论紫杉醇联合奈达铂与紫杉醇联合顺铂同步放化疗治疗局部晚期非小细胞肺癌疗效确切,但紫杉醇联合奈达铂比紫杉醇联合顺铂患者耐受性更好。

Objective To observe efficacy and adverse reactions of the low-doses of paclitaxel weekly combined with nedaplatin or cisplatin concurrent with radiotherapy and chemotherapy for locally advanced non-small cell lung cancer （NSCLC）. Methods 58 patients with inoperable stage III non-small cell lung cancer （22 cases with Ilia and stage 36 cases with IIIb） were randomly divided into observation group and control group. In observation group of 29 cases： paclitaxel 45mg/m2 d1＋ nedaplatin 25 mg/m2 dl once a week, while in control group of 29 cases： paclitaxel 45mg/m2 dl ＋ cisplatin 25 mg/m2 dl. All pationts in two groups accepted three-dimensional conformal radiotherapy （GTV： 6600cGy/30f/6＋w, CTV： 6000 cGy/30F/6＋w, PTV： 5400 cGy/30F/6＋ w）. Results In observation group CR lcases, PR 17cases, the total response rate （CR＋PR） was 66.7%, and in the control group： CR 0 cases; PR 15 cases, the total response rate （CR＋PR） was 71.4% （P〉0.05）, the difference was not statistically significant between two groups. There was no significant difference in two groups patients with leukopenia, anemia, liver damage, radiation pneumonitis and radiation esophagitis, respectively; but renal damage, nausea, vomiting and weight loss （〉10%） rate were significantly lower than the control group, with statistically significant （P〈0.05）. Conclusion The effective between two regimens is the same for locally advanced non-small cell lung cancer, but paclitaxel combined with nedaplatin is better tolerated than paclitaxel plus cisplatin when synchronous radiotherapy.