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不可手术切除Ⅲ期非小细胞肺癌恩度联合同期放化疗多中心Ⅰ+Ⅱ期临床试验 被引量:14

A prospective phase Ⅰ / Ⅱ study of recombinant endostatin (Endostar) combined with concurrent radio-chemotherapy in patients with unresectable stage HI non-small cell lung cancer
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摘要 目的评估重组人血管内皮抑素(恩度)联合同期放化疗不可手术切除Ⅲ期非小细胞肺癌(NSCLC)的有效性及安全性。方法2009--2011年入组的47例患者6~7周内接受三维适形放疗60—66Gv,放疗同期多西他赛65mg/m2加顺铂65mg/m2化疗两程,放疗前1周及第2、4、6周每天接受恩度静滴7.5mg/m2。完成治疗4周后按RECIST 1.1标准评价近期疗效,根据CTCAE3.0评估不良反应。结果44例患者完成治疗和不良反应评价,42例完成近期疗效评价。完全缓解5例,部分缓解29例,稳定3例,进展5例,有效率为77%。1年生存率、无进展生存率分别为81%、51%。死亡12例,2例死于不良反应,8例死于肿瘤,2例死因不明。3、4级中性粒细胞减少19例,3级急性放射性食管炎和肺炎各4例。结论恩度联合同期放化疗不可手术切除Ⅲ期NSCLC近期疗效和耐受性良好,值得进一步研究。 Objective To evaluate the efficacy and safety of recombinant endostatin (Endostar) combined with concurrent radio-chemotherapy (CRCT) in patients with unresectable stage m non-small cell lung cancer (NSCLC). Methods From March 2009 to November 2011,47 patients received three- dimensional conformal radiotherapy of 60 - 66 Gy in 30 - 33 fractions over 6 - 7 weeks And concurrent chemotherapy of docetaxel 65 mg/m2 and cisplatin 65 mg/m2. Endostar was administered once a week before and on week 2, 4, 6 during CRCT at a dose level of 7.5 mg/m2/d. Tumor response was evaluated with thoracic CT scans performed 4 weeks after completion of treatment in accordance with RECIST 1.1 criteria. Acute toxicities were evaluated in accordance with CTCAE 3.0. Results Forty-four patients completed treatment and toxicity evaluation, 42 patients completed evaluation of efficacy. Five patients achieved complete response, 29 partial response, 3 stable disease, and 5 progressive disease, 2 were not assessed. Overall response rate was 77%. One-year overall survival rate was 81% , and one-year progression-free survival rate was 51%. Twelve patients died, 2 died of treatment related toxicities, 8 of cancer, and 2 of unknown causes. Nineteen patients developed grade 3/4 neutrocytopenia, grade 3 acute esophagitis and pneumonitis were observed in 4 and 4 patients, respectively, and 1 patient died of pneumonitis. No patient developed cardiovascular toxicities and hemorrhage. Conclusions Endostar combined with CRCT for unresectable stage m NSCLC was safe and the short term outcomes were promising. Further investigations are warranted.
出处 《中华放射肿瘤学杂志》 CSCD 北大核心 2012年第6期500-503,共4页 Chinese Journal of Radiation Oncology
基金 国家自然科学基金项目(30872974,81172116) 广东省科技计划项目(20098030801154)
关键词 非小细胞肺 放化疗法 血管内皮抑素 预后 Carcinoma, non-small cell lung/radio-chemotherapy Endostar Prognosis
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参考文献21

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二级参考文献87

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