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靶向治疗药物的Ⅲ期临床试验设计 被引量:2

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摘要 肿瘤发生和发展过程中的各种关键的生物学行为受到由各种基因和信号传导通路组成的异常复杂的网络系统的调控,这个系统中的各种基因和分子也为肿瘤治疗提供了丰富的靶点。近年来,针对这些靶点的靶向治疗药物已广泛的应用于I临床医疗。
作者 戚川 周彩存
出处 《中国医药导刊》 2010年第8期1356-1357,共2页 Chinese Journal of Medicinal Guide
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  • 1Slamon DJ,Leyland-Jones B,Shak S,et al.Use of chemotherapy plus a monoclonal anti body against HER2 for metastatic breast cancer that overexpresses HER2.N Engl J Med,2001;344(11):783-792.
  • 2Romond EH,Perez EA,Bryant J,et al.Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer.N Engl J Med,2005; 353(16):1673-1684.
  • 3Van Cutsem E,Kang Y,Chung H,et al.Efficacy results from the ToGA trial:A phase Ⅲ study of trastuzumab added to standard chemotherapy (CT) in first-line humam epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (GC).J Clin Oncol,2009;27(18s):LBA4509.
  • 4Thatcher N,Chang A,Parikh P,et al.Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer:results from a randomised,placebo-controlled,multicentre study (Iressa Survival Evaluation in Lung Cancer).Lancet,2005;366(9496):1527-37.
  • 5Mok T,Wu YL,Thongprasert S,et al.Phase Ⅲ,randomised,open-label,first-line study of gefitinib (G) vs carboplatin/paclitaxel (C/P) in clinically selected patients (pts) with advanced non-small cell lung cancer (NSCLC) (IPASS).Presented at:European Society for Clinical Oncology Congress.Stockholm,Sweden,12-16September 2008.
  • 6Cunningham D,Humblet Y,Siena S,et al.Cetuximab monotherapy and cetuximab plus irinotecan in irinotecanrefractory metastatic colorectal cancer.N Engl J Med,2004;351 (4):337-345.
  • 7Chung,KY,Shia J,Kemeny NE,et al.Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry.J Clin Oncol,2005 ;23(9):1803-1810.
  • 8Saltz LB.Can the addition of cetuximab to irinotecan improve outcome in colorectal cancer? Nat Clin Pract Oncol,2005;2(1):20-21.
  • 9Cappuzzo F,Ciuleanu T,Stelmakh L,et al.SATURN:A double-blind,randomized,phase Ⅲ study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC.J Clin Oncol,2009;27(15s):8001.
  • 10Cobo M,Isla D,Massuti B,et al.Customizing cisplatin based on quantitative excision repair crosscomplementing 1mRNA expression:a phase Ⅲ trial in nonsmall-cell lung cancer.J Clin Oncol,2007;25:2747-54.

同被引文献11

  • 1Hoering A,Leblanc M,Crowley JJ. Randomizedphase IH clinical trial designs for targeted agents[J].Clin Cancer Res,2008,14(14) :4358-4367.
  • 2Wu W,Shi Q,Sargent DJ. Statistical considera-tions for the next generation of clinical trials [J].Semin Oncol.2011,38(4) :598-604.
  • 3Freidlin B,McShane LM,Korn EL. Randomizedclinical trials with biomarkers:design issues[J].JNatl Cancer Inst,2010,102(3) :152-160.
  • 4Sargent D,Allegra C. Issues in clinical trial designfor tumor marker studies[J].Semin Oncol>2002,29(3):222-230.
  • 5Fox E,Curt GA,Bails FM. Clinical trial design fortarget-based therapy [J].Oncologist,2002,7(5):401-409.
  • 6Maitournam A,Simon R. On the efficiency of tar-geted clinical trials[J],Statist Med,2005,24(3):329-339.
  • 7Hayes DF,Trock B,Harris AL. Assessing theclinical impact of prognostic factors :when is statis-tically significant clinically useful[J].Breast CancerRes Treat,1998,52(1/2/3):305-319.
  • 8陈林,刘玉秀,刘丽霞,成琪.靶向临床试验效应估计的偏倚及校正[J].中国临床药理学与治疗学,2012,17(8):892-895. 被引量:1
  • 9陈林,刘玉秀,缪华章.靶向临床试验不同设计方法的统计学性能比较[J].中国临床药理学与治疗学,2013,18(4):399-403. 被引量:1
  • 10杨志敏,李宁,高晨燕,陈晓媛,张杰.富集设计的理论与方法及其在新药临床开发中的应用[J].中国新药杂志,2014,23(8):915-920. 被引量:10

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