重组人血管内皮抑素联合同步放化治疗局部晚期非小细胞肺癌

Recombinant human endostatin combined with concurrent chemoradiotherapy in treatment of locally advanced non-small cell lung cancer

目的评估重组人血管内皮抑素（恩度）联合多西紫杉醇与顺铂同步放化治疗局部晚期非小细胞肺癌的近期疗效及不良反应。方法28例经组织学确诊符合入组条件的ⅢA或ⅢB非小细胞肺癌患者随机分成试验组和对照组，每组14例。试验组采用恩度联合同步放化疗，对照组采用同步放化疗，观察两组的疗效及不良反应。结果试验组、对照组放后的缓解率分别为71．4％和64．3％，差异无统计学意义（P〉0．05），残留病灶立体定向体部放疗补量后各组缓解率均有进一步提高，总缓解率分别达85．71％和78．57％，差异无统计学意义（P〉0．05）。截至末次随访，试验与对照组肿瘤进展时间（TTP）、1年无进展生存率、1年生存率、估计的中位生存期（MST）分别为13．0月和11．8月，64．3％和57．1％，78．6％和85．7％，21．1月和19．8月，差异均无统计学意义（P〉0．05）。主要的不良反应有骨髓抑制、恶心呕吐、I-Ⅱ级急性放射性肺炎及食管炎，两组不良反应差异均无统计学意义（P〉0．05）。结论多西紫杉醇与顺铂同步放化（以3DCRT为基础放疗）联合重组人血管内皮抑素（恩度）治疗经选择的局部晚期非小细胞肺癌耐受性良好、不良反应可接受。

Objective To evaluate the efficacy and safety of docetaxel and cisplatin （DP） concurrent chemoradiotherapy combined with recombinant human endostatin （endostar） in patients with inoperable locally advanced non-small-cell lung cancer （LANSCLC）. Methods A total of 28 patients diagnosed with inoperable LANSCLC （ⅢA or Ⅲ B） were randomly divided into two groups . Patients of the experimental group（n = 14） were treated with endostar combined DP chemotherapy （docetaxel 75 mg/m2 on day 1, cisplatin 20 mg/m2 on day 1 -4 and endostar 15 mg/d on day 1 - 14 ,repeated every 3 -4 weeks and with 3 to 4 cycles） and concurrent thoracic radiotherapy while the patients of the control group（ n = 14） were treated with DP concurrent chemoradiotherapy only. The primary tumors and involved lymph nodes wereadministrated three-dimensional conformal radiotherapy （3DCRT） at a total dose of 50 to 60 Gy （200 cGy! fraction ,51Yweek, completed in 5 to 6 weeks） to all patients. After 4 -6 weeks patients with residual tumor lesions received additional stereotactic body radiotherapy（SBRT） at the doses of 18 -27 Gy （300 cGy/ fraction, every other day） not beyond the tolerated doses of surrounding important normal organs. The efficacy was evaluated according to RECIST criteria. The adverse reactions were evaluated according to NCI CTC3.0 criteria and RTOG/EORT radiation reaction criteria. Results The response rate （ CR ＋ PR） was 71.4% in the experimental group and 64.3% in control group after 3DCRT（P 〉 O. 05）. Though the overall response rate raised after SBRT in both groups （85.71% vs 78.57% ）, the diversities were not significant（P 〉 0. 05 ）. Till last follow-up day, time to progression （TIP） and 1-year progression free survival rate and 1-year overall survival rate and median survival time （MST） in experimental group myelosuppression and control group were 13.0 m vs 11.8 m,64.3% vs 57.1% ,78.6% vs 85.7% and 21.1 m vsl9.8 m respectively without significant difference （P 〉 0.05 ）. The main adverse reactions of both groups include , nausea and vomiting, grade 1 to 2 acute radiation pneumonitis and acute radiation esophagitis （ P 〉 0. 05 ）. Though the experimental group patients were observed with more transient cardiovascular adverse reactions ,the diversities were not significant（ P 〉 0.05 ）. All the adverse reactions could be relieved and tolerated after appropriate treatment. Both group patients were not observed with hemorrhage,grade g hematoblast depression, grade 3 to 4 acute radiation pneumonitis and acute radiation esophagitis. Conclusion The concurrent chemoradiotherapy （based on 3DCRT） of docetaxel and cisplatin combined with recombinant human endostatin （endostar） can be considered as an effective and feasible approach for the treatment of chosen inoperable LANSCLC.