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
불가수술절제Ⅲ기비소세포폐암은도연합동기방화료다중심Ⅰ+Ⅱ기림상시험
A prospective phase Ⅰ / Ⅱ study of recombinant endostatin (Endostar) combined with concurrent radio-chemotherapy in patients with unresectable stage Ⅲ non-small cell lung cancer
  • 万方数据
    中华放射肿瘤学杂志 중화방사종류학잡지
    CHINESE JOURNAL OF RADIATION ONCOLOGY
    2012年 6期 500-503 ,共4页

    周琦超%包勇%余忠华%李建成%程志斌%陈龙%胡晓%王彦%王谨%彭芳%徐祖敏%马红莲%卢儒彪%陈明%邓小武

    주기초%포용%여충화%리건성%정지빈%진룡%호효%왕언%왕근%팽방%서조민%마홍련%로유표%진명%산소무

    癌%非小细胞肺/放化疗法%血管内皮抑素%预后 癌%非小細胞肺/放化療法%血管內皮抑素%預後
    암%비소세포폐/방화요법%혈관내피억소%예후
    Carcinoma,non-small cell lung/radio-chemotherapy%Endostar%Prognosis
    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～ 66 Gy,放疗同期多西他赛65 mg/m2加顺铂65 mg/m2化疗两程,放疗前1周及第2、4、6周每天接受恩度静滴7.5 mg/m2.完成治疗4周后按RECIST1.1标准评价近期疗效,根据CTCAE 3.0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.
    목적 평고중조인혈관내피억소(은도)연합동기방화료불가수술절제Ⅲ기비소세포폐암(NSCLC)적유효성급안전성.방법 2009-2011년입조적47례환자6～7주내접수삼유괄형방료60～ 66 Gy,방료동기다서타새65 mg/m2가순박65 mg/m2화료량정,방료전1주급제2、4、6주매천접수은도정적7.5 mg/m2.완성치료4주후안RECIST1.1표준평개근기료효,근거CTCAE 3.0평고불량반응.결과 44례환자완성치료화불량반응평개,42례완성근기료효평개.완전완해5례,부분완해29례,은정3례,진전5례,유효솔위77％.1년생존솔、무진전생존솔분별위81％、51％.사망12례,2례사우불량반응,8례사우종류,2례사인불명.3、4급중성립세포감소19례,3급급성방사성식관염화폐염각4례.결론 은도연합동기방화료불가수술절제Ⅲ기NSCLC근기료효화내수성량호,치득진일보연구.
    Objective To evaluatc the efficacy and safcty of recombinant endostatin (Endostar)combined with concurrent radio-chemotherapy (CRCT) in patients with unresectable stage Ⅲ non-small cell lung cancer (NSCLC).Methods From March 2009 to November 2011,47 patients received threedimensional 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 net 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 Ⅲ NSCLC was safe and the short term outcomes were promising.Further investigations are warranted.
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