多西他赛联合多柔比星治疗一线化疗失败的非小细胞肺癌Ⅱ期临床研究
다서타새연합다유비성치료일선화료실패적비소세포폐암Ⅱ기림상연구
A randomized phase Ⅱ trial of docetaxel and doxorubicin in treatment for patients with non-small-cell lung cancer who have failed previous platinum-based chemotherapy
  • 万方数据
    中华肿瘤杂志 중화종류잡지
    CHINESE JOURNAL OF ONCOLOGY
    2008年 6期 465-468 ,共4页

    王子平%孙燕%张湘茹%张茂宏%王秀问%于学军%南克俊%李恩孝%刘基巍%高亚杰%关小倩%宋恕平%盛立军%王东林%王志新

    왕자평%손연%장상여%장무굉%왕수문%우학군%남극준%리은효%류기외%고아걸%관소천%송서평%성립군%왕동림%왕지신

    多西他赛%多柔比星%非小细胞肺癌 多西他賽%多柔比星%非小細胞肺癌
    다서타새%다유비성%비소세포폐암
    Docetaxel%Doxorubicin%Carcinoma,non-small-call lung
    目的 观察国产多西他赛注射液联合多柔比星治疗经一线化疗失败的非小细胞肺癌(NSCLC)的临床疗效及毒副反应,并对安全性进行评估.方法 对88例经含铂类药物化疗后进展的NSCLC患者,使用多柔比星40mg/m2静脉冲人,第1天;国产(试验组)或进口(对照组)多西他赛注射液70 mg/m2静脉滴注,第2天.21d为1个周期,治疗3个周期.试验中不预防使用粒细胞集落刺激因子.用世界卫生组织(WHO)的疗效及抗肿瘤药物急性及亚急性毒性反应分度标准评价疗效及毒性,卡式评分评价身体状况变化.结果 88例人组受试者中,81例可评价疗效.试验组和对照组均未出现CR患者,试验组PR、NC和PD患者分别为7、26和8例,对照组分别为3、26和11例.试验组和对照组有效率分别为17.1%和7.5%,临床获益率分别为80.5%和72.5%.两组近期疗效差异无统计学意义.试验组与对照组的不良反应均主要表现为骨髓抑制、脱发及消化道反应等,未见水纳潴留,两组近期疗效差异无统计学意义.结论 国产多西他赛注射液可用于含铂类药物化疗后进展的NSCLC的治疗,疗效显著,耐受性良好.
    목적 관찰국산다서타새주사액연합다유비성치료경일선화료실패적비소세포폐암(NSCLC)적림상료효급독부반응,병대안전성진행평고.방법 대88례경함박류약물화료후진전적NSCLC환자,사용다유비성40mg/m2정맥충인,제1천;국산(시험조)혹진구(대조조)다서타새주사액70 mg/m2정맥적주,제2천.21d위1개주기,치료3개주기.시험중불예방사용립세포집락자격인자.용세계위생조직(WHO)적료효급항종류약물급성급아급성독성반응분도표준평개료효급독성,잡식평분평개신체상황변화.결과 88례인조수시자중,81례가평개료효.시험조화대조조균미출현CR환자,시험조PR、NC화PD환자분별위7、26화8례,대조조분별위3、26화11례.시험조화대조조유효솔분별위17.1%화7.5%,림상획익솔분별위80.5%화72.5%.량조근기료효차이무통계학의의.시험조여대조조적불량반응균주요표현위골수억제、탈발급소화도반응등,미견수납저류,량조근기료효차이무통계학의의.결론 국산다서타새주사액가용우함박류약물화료후진전적NSCLC적치료,료효현저,내수성량호.
    Objective The aim of this study was to evaluate the efficacy, toxicity and safety of doxorubicin combined with domestically produced docetaxel versus with taxotere, and to investigate whether these two regimens result in similar outcomes in the treatment for non-small-cell lung cancer (NSCLC) patients who failed previous platinum-bused chemotherapy. Methods Eighty-eight NSCLC patients were enrolled into this clinical phase Ⅱ trial. The patients randomly received either domestic docetaxel (study arm) or taxotere (control arm) at a dose of 70 mg/m2 on D2, while doxorubicin at a dose of 40 mg/m2 onD1 was administered in both groups. It was repeated every 3 weeks, totally for three cycles. No granulocyte colony-stimulating factor was used to prevent granulocytopenia. The response rate and toxicity were evaluated using World Health Organization toxicity scale and Karnofsky performance status scale. Results Of the 88patients, 81 were evaluable in terms of efficacy. There was no complete responder in this series. The response rate (RR) was 17.1% in the study arm versus 7.5% in the control arm, and the clinical benefit rate (CBR) was 80.5% in the study group versus 72.5% in the control group. The most frequent grade 3 or4 toxicities were neutropenia, leucopenia and gastrointestinal symptoms. Other toxicities such as alopecia and vomiting were mild and generally well tolerated. No fluid retention was noticed. Conclusion The administration of doxorubicin 40 mg/m2 on D1 combined with domestic docetaxel 70 mg/m2 on D2 is proved to be as effective and tolerable as with taxotere. The domestic drug docetaxel may be considered as an alternative for patients with non-small-cell lung cancer who failed previous platinum-based chemotherapy.
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