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NICE指南草案不推荐贝伐珠单抗/卡培他滨治疗乳腺癌

2012-04-20 卢秀玲 爱唯医学网

贝伐珠单抗卡培他滨乳腺癌NICE
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       英国临床优化研究所(NICE)日前表示，将不会建议贝伐珠单抗联合卡培他滨治疗进展性转移性乳腺癌。在4月18日发布的新指南草案中，NICE指出，支持这种联合治疗的证据不足。目前已有2种含贝伐珠单抗的方案被欧盟批准作为进展性转移性乳腺癌的一线治疗，本次被NICE否定的方案是其中之一。        

       英国临床优化研究所(NICE)日前表示，将不会建议贝伐珠单抗联合卡培他滨治疗进展性转移性乳腺癌。在4月18日发布的新指南草案中，NICE指出，支持这种联合治疗的证据不足。目前已有2种含贝伐珠单抗的方案被欧盟批准作为进展性转移性乳腺癌的一线治疗，本次被NICE否定的方案是其中之一。

贝伐珠单抗联合卡培他滨
 
       罗氏的贝伐珠单抗(阿瓦斯汀)是一种人源化单克隆抗体，可阻断血管内皮生长因子，从而减少肿瘤的血供。美国食品药品管理局(FDA)认为风险-收益比率不理想，已于2011年11月撤销了贝伐珠单抗的乳腺癌适应证。但欧洲药品管理局(EMA)并未附和FDA。贝伐珠单抗已在欧洲被批准与紫杉醇或卡培他滨(当紫杉醇被认为不适用时)联用，用于治疗进展性转移性乳腺癌。而在2011年2月，NICE驳回了贝伐珠单抗联合紫杉醇用于该适应证的申请。
 
       在宣布有关贝伐珠单抗联合卡培他滨的决定时，NICE表示不确定RIBBON-1的总生存收益结果。RIBBON-1是一项随机对照试验，共招募1,237例进展性乳腺癌女性患者，其中615例患者被随机分入卡培他滨+贝伐珠单抗组或卡培他滨+安慰剂组。尽管试验结果显示，与卡培他滨单药治疗相比，卡培他滨+贝伐珠单抗可使无进展生存期延长2.9个月，但这一收益能否转化为总生存期的改善却并不确定，因为在该试验的开放性进展后阶段中有很多患者从单药治疗转为联合治疗。
 
       NICE还指出，该试验未采集生活质量方面的数据，而且贝伐珠单抗+卡培他滨组的严重不良反应发生率高于卡培他滨+安慰剂组(36.6% vs. 22.9%)。“此外，高血压、蛋白尿、感觉神经病变和静脉血栓栓塞事件在贝伐珠单抗+卡培他滨组中更多见。因此，委员会的结论是，贝伐珠单抗+卡培他滨的毒性特征逊于卡培他滨+安慰剂。”
 
       最后还有费用的问题。生产商提出的贝伐珠单抗+卡培他滨的最佳病例边际成本-效益比率(ICER)为花费82,000英镑(约合900,000元人民币)可获得1个质量调整生命年(QALY)，而且这还只是单个亚组的数据。贝伐珠单抗的ICER远远超出了NICE认为合理的成本-效益范围。贝伐珠单抗通过静脉注射给药，每3周注射15 mg/kg，每例患者的平均每月费用约为3,689英镑(约合37,300元人民币)。 

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    2012-11-20 仁医06

    #贝伐珠#

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    2012-04-22 fusion

    #NICE#

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    2012-04-22 w363522449

    #卡培他滨#

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    2012-04-22 sunrural_42825359

    #贝伐#

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