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JCO：西妥昔单抗联合顺铂可改善三阴性乳腺癌患者生存

2013-07-03 ecoliDH5 dxy

JCO西妥昔单抗顺铂三阴性乳腺癌
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作为乳腺癌中的一种侵袭性亚型，转移性三阴性乳腺癌(mTNBC)会出现表皮生长因子受体的过量表达。针对这种情况，美国纪念斯隆凯特琳癌症中心的Jose Baselga博士等人进行了一项研究，这项项随机临床II期研究对顺铂联合或部联合西妥昔单抗进行了考察。该研究结果发表于2013年6月3日在线出版的《临床肿瘤学杂志》(Journal of ClinicalOncology)上。 参试患者此前未接受或仅

作为乳腺癌中的一种侵袭性亚型，转移性三阴性乳腺癌(mTNBC)会出现表皮生长因子受体的过量表达。针对这种情况，美国纪念斯隆凯特琳癌症中心的Jose Baselga博士等人进行了一项研究，这项项随机临床II期研究对顺铂联合或部联合西妥昔单抗进行了考察。该研究结果发表于2013年6月3日在线出版的《临床肿瘤学杂志》(Journal of ClinicalOncology)上。
参试患者此前未接受或仅接受过一次化疗，患者按2:1的随机分配方式，接受不超过六个周期的顺铂联合西妥昔单抗方案或单纯的顺铂方案治疗。根据病情进展情况，单纯接受顺铂治疗的患者可切换至顺铂联合西妥昔单抗治疗，或仅通过西妥昔单抗治疗。该研究主要终点为总缓解率(ORR)。研究次要终点则包括无进展生存率(PFS)、总生存率(OS)及安全性。研究人员按显著性水平α = .10进行相关分析，并且未对多样性进行校正。
总分析集共包括115例接受顺铂与西妥昔单抗联合方案治疗的患者，以及58例单纯接受顺铂方案治疗的患者；共有31例接受单纯顺铂方案治疗的患者因病情进展而转而接受含西妥昔单抗治疗。研究结果显示，顺铂与西妥昔单抗联合方案组ORR为20% (95% CI, 13至29)，单纯顺铂方案组贼为10% (95% CI, 4至21) (比值比,2.13; 95% CI, 0.81至 5.59; P =.11)。与单纯的顺铂方案相比，顺铂与西妥昔单抗联合方案可延长患者PFS(中位值, 3.7 v 1.5个月;风险比 [HR], 0.67; 95% CI, 0.47 至0.97; P = .032)。对应的OS中位值则分别为12.9及9.4 个月 (HR,0.82; 95% CI, 0.56至1.20; P =.31)。常见的3/4级不良事件包括痤疮样皮疹、中性粒细胞减少及疲劳。
尽管并未达到主要终点，但该研究发现，西妥昔单抗联合顺铂可倍增ORR，并可能延长患者PFS及OS，这一结果为该方案在mTNBC的进一步研究提供了支持。

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    2013-10-31 lidong40

    #JCO#

    0

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    2013-08-27 tastas

    #患者生存#

    0

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    2013-09-24 circumcision

    #阴性乳腺癌#

    0

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    2013-09-05 ms3153534357578991

    #铂#

    0

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    2013-12-13 chengjn

    #西妥昔#

    0

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    2013-07-05 xlysu

    #三阴性#

    0

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    2013-07-05 hanhaisha2013

    #乳腺癌患者#

    0

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