ESMO 2014：吉西他滨联合顺铂(GP)或紫杉醇(GT)一线治疗复发或转移性三阴性乳腺癌获良好疗效(CBCSG006试验)

2014-10-02 肿瘤瞭望微信

在欧洲肿瘤内科学会(ESMO)2014年大会现场，马德里时间9月28日午间在Cordoba会议厅举办了一场主题”Metastatic and locally advanced breast cancer: Facing with heterogeneity and endpoints in clinical trials”的壁报讨论会，其中，来自中国复旦大学附属肿瘤医院的胡夕春教授提供的一篇标题为

在欧洲肿瘤内科学会(ESMO)2014年大会现场，马德里时间9月28日午间在Cordoba会议厅举办了一场主题”Metastatic and locally advanced breast cancer: Facing with heterogeneity and endpoints in clinical trials”的壁报讨论会，其中，来自中国复旦大学附属肿瘤医院的胡夕春教授提供的一篇标题为“吉西他滨联合顺铂(GP)或紫杉醇(GT)一线治疗复发或转移性三阴性乳腺癌的全国多中心III期CBCSG006试验”引起了广泛的兴趣，为三阴性乳腺癌的治疗带来新的希望和选择。会后，作为胡夕春教授壁报的讨论主持人，来自西班牙科尔多瓦大学的肿瘤学教授JuandelaHaba与胡夕春教授就三阴性乳腺癌的治疗策略，进行了深入探讨。

胡夕春教授与他发表的CBCSG006研究壁报

JuandelaHaba教授现场讨论胡夕春教授的壁报

化疗在三阴性乳腺癌治疗中的基石地位不可动摇

尽管分子靶向治疗在乳腺癌某些亚型中取得了一定进展，例如LuminalA型和HER2阳性患者，但对三阴性患者来说目前效果甚微。几年前，业内曾经认为曲妥珠单抗对三阴性患者有效，但在对3项临床试验进行meta分析之后，发现并无生存益处。所以，尽管临床上希望能应用靶向治疗来改善这类患者的预后，但截至目前为止，化疗仍是三阴性乳腺癌患者的标准治疗方案。

反击耐药细胞株：CBCSG006研究目的及设计考虑

CBCSG006研究由中国抗癌协会乳腺癌专业委员会发起，礼来中国公司支持,最早开始于2010年。临床前数据确定了三阴性乳腺癌细胞株MDA-MB-231，在II期临床试验中我们发现吉西他滨对耐药细胞株有效。这个令人兴奋的结果促成胡夕春教授团队在全国多中心开展III期临床试验，评价GP方案(吉西他滨+顺铂)一线治疗三阴性乳腺癌患者的效果。

2012ESMO和2013年NCCN指南均推荐采用GT方案(吉西他滨+紫杉醇)作为转移或复发三阴性乳腺癌的化疗方案。CBCSG006研究是第一项在三阴性乳腺癌患者中直接对比GP和GT方案的III期临床试验，其结果具有重大意义，可能为三阴性患者树立新的联合化疗方案。

PFS延长1.3个月，安全性更好：CBCSG006研究结果

JuandelaHaba教授认为，就主要终点而言，CBCSG006研究取得了阳性结果。吉西他滨+顺铂方案将缓解率提高了将近18%，中位无进展生存期(PFS)延长了1.3个月。总生存期的数据目前还不成熟。要想证明一种疗法可改善乳腺癌患者的总生存期是很困难的，如能改善PFS便已足够!另外他还强调了一点：GP方案不会引起脱发，这对患者而言至关重要，也是他们采用这种方案的一个原因。

不同指南推荐方案的差异性：XT方案安全性并不理想

虽然NCCN和ESMO指南也推荐了另一种化疗方案：XT方案(卡培他滨+多烯紫杉醇)，但JuandelaHaba教授表示，他们团队在临床实践中发现其毒性很高，真正使用的患者很少，因此我们在临床中并不将其作为一种标准方案来使用。而且胡教授认为，在中国高达95%的早期乳腺癌患者之前已经使用过紫杉烷类药物，主要就是紫杉醇和多烯紫杉醇，所以我们必须探索另一种新的治疗选择。

晚期乳腺癌，包括三阴性乳腺癌的一线治疗应选择以吉西他滨为基础的联合化疗

JuandelaHaba教授认为在临床实践中应当以吉西他滨为基础的方案作为转移和局部晚期乳腺癌的一线治疗，对三阴性患者也有效，因此，可将其作为这类患者的标准治疗方案。胡教授则表示，除乳腺癌外，还在其他实体瘤如膀胱癌中评估了以吉西他滨为基础的方案，并将其用于头颈部鳞状细胞的治疗，而且这种方案的毒性也已在人类患者中进行了充分评估。

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2015-10-15 hjj0000

统计得出的结论有多大的可信度呢

176 0
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2015-04-20 liuhuangbo

#SMO#

39 0
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2015-08-10 ms3153534357578991

#铂#

27 0
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2014-12-24 小刀医生

#转移性三阴性乳腺癌#

42 0
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2015-02-02 circumcision

#阴性乳腺癌#

38 0
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2014-10-04 zhang92560

#ESMO#

43 0
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2014-10-04 1249842em09(暂无昵称)

#转移性#

32 0
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2014-10-04 xlysu

#三阴性#

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ESMO 2014：吉西他滨联合顺铂(GP)或紫杉醇(GT)一线治疗复发或转移性三阴性乳腺癌获良好疗效(CBCSG006试验)

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