JCO：来曲唑联合buparlisib治疗乳腺癌安全可靠

2014-04-22 shumufeng dxy

Buparlisib是一种可逆的抑制所有 I 类磷酸肌醇-3-激酶（PIK3）的口服药物，它无论在单独或联合内分泌治疗雌激素受体阳性乳腺癌细胞株还是在异种移植中都显示出了抗肿瘤活性。这项Ib期研究评估了Buparlisib联合来曲唑在治疗ER阳性、内分泌无反应型、转移性乳腺癌中的安全性、耐受性及初步的抗肿瘤活性。【原文下载】美国那什维尔Vanderbilt大学医学院的Ingrid A. M

Buparlisib是一种可逆的抑制所有 I 类磷酸肌醇-3-激酶（PIK3）的口服药物，它无论在单独或联合内分泌治疗雌激素受体阳性乳腺癌细胞株还是在异种移植中都显示出了抗肿瘤活性。这项Ib期研究评估了Buparlisib联合来曲唑在治疗ER阳性、内分泌无反应型、转移性乳腺癌中的安全性、耐受性及初步的抗肿瘤活性。【原文下载】

美国那什维尔Vanderbilt大学医学院的Ingrid A. Mayer博士等对此进行了深入研究，他们发现来曲唑联合buparlisib联合治疗的两种给药方案都是安全的，同时伴有可逆的毒性反应。其临床活性依赖于PIK3CA基因突变状态。在治疗开始2周时的[18F]FDG-PET/CT 扫描结果显示无代谢反应与疾病快速进展相关。Buparlisib联合内分泌治疗ER阳性乳腺癌的III期临床试验正在进行中。文献发表于2014年3月份的JCO杂志在线版。

入组患者按两个不同的给药方案接受来曲唑联合buparlisib治疗。疗效通过标准实体瘤I期方法进行评估。用18氟脱氧葡萄糖正电子发射计算机体层成像/计算机断层扫描 ([18F]FDG-PET/CT)计算分别在治疗基线和开始治疗2周后进行评价。同时收集肿瘤组织进行PIK3通路基因突变的分析。

结果显示，研究者将51例受试患者分组分别接受连续或间断（用5天停2天）每4周方案口服buparlisib治疗。Buparlisib的最大耐受剂量(MTD)为 100 mg/d。常见的药物相关性不良事件包括不高于2级的高血糖、恶心、疲乏、转氨酶升高及情绪障碍等。所有患者在MTD内治疗的临床获益率 (疾病无进展超过6个月) 为31%（包含在连续治疗组的两个客观反应率）。其中7例患者维持治疗不少于12个月，3例携带有PIK3CA热点突变。在治疗2周后通过[18F]FDG-PET/CT扫描提示疾病代谢进展的患者在治疗中病情也迅速进展。

从该试验结果来看，来曲唑联合buparlisib联合治疗的两种给药方案都是安全的，同时伴有可逆的毒性反应。其临床活性依赖于PIK3CA基因突变状态。在治疗开始2周时的[18F]FDG-PET/CT 扫描结果显示无代谢反应与疾病快速进展相关。Buparlisib联合内分泌治疗ER阳性乳腺癌的III期临床试验正在进行中。

用18氟脱氧葡萄糖正电子发射计算机体层成像/计算机断层扫描（[18F]FDG-PET/CT扫描）评估暴露于 buparlisib (BKM120) 加来曲唑的患者的新陈代谢反应率。（A）连续buparlisib联合来曲唑组有17例患者通过[18F] FDG-PET/CT评估。治疗开始15天后肿瘤[18F]FDG摄入增加25%与新陈代谢部分反应相关，见于9例患者。所有其他7例患者患有新陈代谢稳定性疾病（SD；金色底纹）。有两例患者治疗开始15天后出现新陈代谢部分反应，也存在CT影像学反应（黄色和粉红色阴影）。

原始出处：

Mayer IA1, Abramson VG, Isakoff SJ, Forero A, Balko JM, Kuba MG, Sanders ME, Yap JT, Van den Abbeele AD, Li Y, Cantley LC, Winer E, Arteaga CL.Stand up to cancer phase ib study of pan-phosphoinositide-3-kinase inhibitor buparlisib with letrozole in estrogen receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer.J Clin Oncol. 2014 Apr 20;32(12):1202-9. doi: 10.1200/JCO.2013.54.0518. Epub 2014 Mar 24.【原文下载】

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2014-06-04 chenhongpeng

#uPAR#

68 0
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2014-08-29 liuyong2989

#buparlisib#

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2014-10-22 lidong40

#JCO#

68 0
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2014-04-24 siiner

#来曲唑#

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