HepaSphere 结果小粒径栓塞微粒 载药微球的未来
返回首页

小粒径载药栓塞微球(2)

时间:2018-08-09 21:58来源:未知 作者:Mr.Editor
更好的药物暴露 Better Drug Exposure 较少的肝和全身损伤 Less hepatic / systemic toxicity 对治疗更好的耐受 Better tolerability of the treatment* 2. 潜在缺点 Potential disadvantages 增加非靶栓塞的危险 I
  • 更好的药物暴露 Better Drug Exposure
  • 较少的肝和全身损伤 Less hepatic / systemic toxicity
  • 对治疗更好的耐受 Better tolerability of the treatment*                                  
  •        2. 潜在缺点 Potential disadvantages
    • 增加非靶栓塞的危险 Increased risk of non-target embolization【6,7】
    一组小粒径DEB-TACE的报告(102个结节,结果1)
     
    Mean Follow Up Period: 357 days (30-810)
    Target lesions: RECIST response rate
    Target lesions: mRECIST response rate

    以客观有效率,两种判定肿瘤治疗客观有效率的方法都是有效的,结节越小完全坏死率越高

    Objective Response( CR+ PR )

    小粒径栓塞(结果2)



       


    Arterial phase CT scan of 32mm HCC nodule in segment III, before and after 1 cycle of DEB TACE with 40 um particle. CR according to mRECIST and SD according to RECIST


       
       
       


       
       
       
     

    Time to Respinse (TTR)

    4 mo(95% CI: Range 1-4)
    Progression Free Survival (PFS)
    64.5% (1 year),52% (2 years)
    Median Time To Progression (TTP)
    13 mo (95% CI: Range 11-21)


    证据:小粒径DEB-TACE肝移植后的结果【8】

    - 11/48 patients received OLT
    - Medium time before OLT: 4.8 months
     

    https://www.wjgnet.com/10079327/full/v19/i34/5622.htm

    48例患者,11例接受肝移植。栓塞后接受肝移植中位时间是4.8个月。上表的切除标本显示结节越小,坏死率越高。


    小粒径DEB-TACE的副作用


    Common Terminology Criteria for Adverse Events (CTCAE) 4.0




    结论:


     Initial study results of DEB TACE with 40μm particles show efficacy and a positive safety profile for the treatment of early-intermediate HCC.(早期研究安全有效)
     
     Objective Response, local disease control and adverse events rate in this study is better than reported in literature with bigger particles (100-300 μm) and comparable to recent studies made using particles with similar diameters (30-60 and 70-150 μm)(小粒径比大粒径好)
     
     Histological necrosis rate in transplanted patients was satisfying in nodules with diameter below 3 cm and less satisfying in bigger nodules. 肝移植组织学完全坏死<3cm结节比大结节好
     Superselectivity and tight calibration resulted in less local and systemic toxicity. (超选择)
     Further studies with bigger sample of patients and control group are needed to confirm initial results(还需要大样本对照组研究)
     






       
       
     - DEB-TACE 40μm微粒是有效的

    (反应率63%,疾病控制率96%
     

    小粒径的优势需要与C-TACE

    行比较
       



       




     


     
     
    There was no statistically significant influence on these parameters; however, due to the small size of the sample, an effect cannot be ruled out. The median differences in biochemical parameters between the pre- and post-treatment time points are listed in Table 5


    DEB-TACE:Is Drug Delivery the Main Aim?

    N=101 patients, 51 TACE, 50 bland, 19.6m vs 20.8m (OS, P=.64), TAE vs DEB-TACE 没有意义?
     


    B. Guiu, M. Boulin, J Clin. Oncol. 2017
    No conclusion can be drawn from negative randomized phase II
    • 34% patients had advanced HCC
    • Complete stasis with unloaded beads
    • Primary endpoint using RECIST
    • Weak rationale for doxo


    Chemo- or Bland-embolization??

    Superiority of chemoembolization : No proof!

    5 negative randomized trials…
     But limited number of patients… and signal in favor of chemoembolization…
     

    试验动物病理证实:化疗药物有效

    Persistance of viable tumor with bland embolization
     

     
       

    Lee, CVIR 2010
     
    At D28, bland embo ≠ DEB-TACE

    Normal liver
    Unloaded-DEBs
    Fibrosis
    700-900 Doxo-DEBs
    Necrosis
    100-300 Doxo-DEBs


    Namur J, JVIR 2010
     










     

    1. Kan Z, Madoff DC .Liver anatomy: microcirculation of the liver. Semin Intervent Radiol. 2008 Jun;25(2):77-85
     
    2. Idée JM, Guiu B. Use of Lipiodol as a drug-delivery system for transcatheter arterial chemoembolization of hepatocellular carcinoma: a review. Crit Rev Oncol Hematol. 2013 Dec;88(3):530-49

    3.  Zhou X et al. Doxorubicin-eluting beads versus conventional transarterial chemoembolization for the treatment of hepatocellular carcinoma: a meta-analysis. Int J Clin Exp Med. 2014 Nov 15;7(11):3892-903

    4. Xie ZB et al.(2015) Systematic review comparing the safety and efficacy of conventional and drug-eluting bead transarterial chemoembolization for inoperable hepatocellular carcinoma. Hepatol Res 45(2): 190-200

    5. Bonomo G et al (2010) . Cardiovasc Intervent Radiol 33:552–559

    6. Ruben Lopez-Benitez et al (2009). Cardiovasc Intervent Radiol 32:615–622

    7. Lammer J et al. Precision V. (2010) Cardiovasc Intervent Radiol 33: 41-52

    8. Nicolini D, et al.Doxorubicin-eluting bead vs conventional transcatheter arterial chemoembolization for hepatocellular carcinoma before liver transplantation. World J Gastroenterol. 2013 Sep 14;19(34):5622-32
     

     

    顶一下
    (0)
    0%
    踩一下
    (0)
    0%
    ------分隔线----------------------------
    • 上一篇:没有了
    • 下一篇:没有了
    推荐内容