肺癌同步放化疗中紫杉醇剂量递增临床Ⅰ和Ⅱ期试验

Clinical phaseⅠ/Ⅱstudy of concurrent paclitaxel with radiotherapy for inoperable non-small cell lung cancer after induction chemotherapy

目的 评价诱导化疗后小剂量紫杉醇同时合并放疗不能手术非小细胞肺癌的毒性和疗效。方法 对 2 5例病理确诊的不能手术非小细胞肺癌患者首先接受诺维本 +顺铂方案诱导化疗 2～ 3个周期 ,1个月后接受同步放化疗。三维适形放疗总剂量 6 0Gy ,30分次 ,6～ 7周完成。紫杉醇剂量递增试验每次 15mg/m2 ,共分 5个组 :2次 /周 2周组、2次 /周 4周组、2次 /周 6周组、3次 /周 4周组、3次 /周 6周组 ,每组 3例。 3次 /周 6周组增加 9例 ,以验证其重复性。采用美国RTOG制定的放射反应评价标准评价副反应。若每组 3例中 1例出现 3级以上副反应则在同一剂量水平重复试验。终止试验的标准是 3级以上副反应发生率≥ 2 / 6或剂量达到常规化疗剂量 135mg/m2 。结果 除 1例因紫杉醇过敏反应外 ,2 4例均按计划完成了治疗 ,各剂量组至少已递增 1次。 3次 /周 4周组治疗期间 3例中 1例出现 3级疲劳 ,增加 3例重复该剂量 ,未再发生 3级以上副反应。放化疗期间发生 1、2级放射性食管炎 14例 ,其中需要软食、流质者 2例 ;1、2级放射性肺炎 7例 ,其中需要激素治疗的 2级3例。 2 4例疗后评价完全缓解 2例 ,部分缓解 17例 ,病情稳定 3例 ,进展的 2例分别转移至肝脏、腹膜后淋巴结。结论 诱导化疗后每次 15mg/m2 、3次 /周 6周的?

Objective To evaluate the radiosensitization of low dose paclitaxe l on inoperable non-small cell lung cancer (NSCLC) after induction chemotherapy . Methods Previously untreated 25 patients with histologically/cytologically prov en unresectable NSCLC were eligible. Induction chemotherapy regimen included Novelbine 25?mg/ m2 i.v. on D1,D8, and cisplatin 45?mg/m2 i.v. o n D8,D9, repeated every 4 weeks, 2-3 cycles in all, followed a month later by continual 3 D radiotherapy (60?Gy in 30 fractions) delivered concurrently with paclitaxel at a dose of 15?mg/m2 iv every Monday, Wednesday, Friday. Major toxicities wer e evaluated with Current Toxicity Criteria 2.0. Results Twenty-five patients were al loted.But one patient was excluded because of hypersensitivity to paclitaxel, th erefore twenty-four patients were evaluable. The side effects of radiotherapy p l us concurrent low dose paclitaxel were: 14 patients had radiation esophagitis of Ⅰ-Ⅱdegree, 7 patients had radiation pneumonitis of Ⅰ-Ⅱ degree, 1 patient de veloped serious (Ⅲ degree) extreme weariness which necessitated secession of ch emotherapy. The treatment results were: CR 2 patients,PR 17 patients . The imme diate response rate was 79.2%. Conclusion Induction chemotherapy plus radiothera py given concurrent low dose paclitaxel is safe and effective for inoperable NS CLC.