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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 short-term efficacy and side effects of recombinant human endostatin (Endostar) combined with docetaxel and cisplatin in the concurrent treatment of locally advanced non-small cell lung cancer. Methods Twenty - eight patients with histologically confirmed ⅢA or ⅢB non - small cell lung cancer who were eligible for inclusion were randomly divided into test group and control group, with 14 cases in each group. In the experimental group, Endeng combined with concurrent chemoradiotherapy was used. In the control group, concurrent chemoradiotherapy was used to observe the curative effect and adverse reactions in both groups. Results The remission rates of experimental group and control group after radiotherapy were 71.4% and 64.3%, respectively, with no significant difference (P> 0.05). The remission rate of stereotactic body radiotherapy of residual lesion was further improved The response rates were 85.71% and 78.57% respectively, with no significant difference (P> 0.05). As of the last follow-up, the TTP, 1-year progression-free survival, 1-year survival and estimated median survival (MST) were 13.0 and 11.8 months, 64.3% and 57.1% in the trial and control group, 78.6% and 85.7%, respectively. There was no significant difference between 21.1 and 19.8 months (P> 0.05). The main adverse reactions were myelosuppression, nausea and vomiting, grade Ⅰ ~ Ⅱ acute radiation pneumonitis and esophagitis. There was no significant difference in adverse reactions between the two groups (P> 0.05). Conclusions The combination of docetaxel and cisplatin in synchronized radiotherapy (based on 3DCRT-based radiotherapy) combined with recombinant human endostatin (Endostar) in the treatment of selected locally advanced non-small cell lung cancer is well tolerated and the adverse reactions are acceptable.