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美国希望之光

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注册: 2015-02-03

[交流] 美国2015年乳腺癌治疗重磅级新药已有1人参与

2015年2月3日，美国食品和药物管理局（FDA）加速批准了Palbociclib（商品名Ibrance，美国辉瑞公司生产）联合来曲唑用于治疗ER阳性、HER2阴性、绝经后的晚期乳腺癌的首选内分泌治疗。
Palbociclib是一种CDK4/6抑制剂。这项批准是基于一项随机临床试验研究的有效结果，该研究患者入组标准是：绝经后的、ER阳性、HER2阴性、局部晚期或转移的、针对晚期病灶先前没有接受过系统治疗的乳腺癌患者。该研究纳入165名患者，随机分为两组：接受Palbociclib+来曲唑组或单独来曲唑组。
结果显示平均无进展生存期（PFS）在Palbociclib加来曲唑组为20.2个月，在单独使用来曲唑组为10.2个月。
最常见的不良反应（发生率≥10%）是：中性粒细胞减少、白细胞减少、乏力、贫血、上呼吸道感染、恶心、口腔炎、脱发、腹泻、血小板减少症、食欲下降、呕吐、无力、周围神经病变和鼻出血。在Palbociclib加来曲唑组发生频率最高的严重不良反应是：肺栓塞（4%）和腹泻（2%）。
Palbociclib推荐的剂量和用法是：每天125毫克，连用21天，休息7天；同时给予来曲唑每天2.5毫克，连用28天。
Palbociclib的详细处方信息详见：http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf
注：
Palbociclib的创新之处在于以雌激素受体为靶标，阻断CDK4和CDK6两种酶；为有转移的绝经后乳腺癌患者提供了新的治疗方案：Palbociclib加来曲唑。
CDK4/6是细胞分裂周期的重要调节蛋白，诱发细胞从G1到S阶段的转化。抑制CDK4/6不仅可以使细胞分裂停止，而且可以杀死已有的癌细胞。
翻译：美国 Methodist Hospital 肿瘤、血液专家、内科副主任 Henry Wang
美国 City of Hope National Medical Center 访问学者 Dr. Wang Hailong
原文：
On February 3, 2015, the U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. The approval is based on a randomized trial in postmenopausal women with ER-positive, HER2-negative, locally advanced or metastatic breast cancer who had not received previous systemic treatment for advanced disease. The trial enrolled 165 patients randomly allocated to receive either palbociclib plus letrozole or letrozole alone.
Median progression-free survival (PFS) was 20.2 months in the palbociclib plus letrozole arm and 10.2 months in the letrozole alone arm.
Most common adverse reactions (greater than or equal to 10%) were neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis. The most frequently reported serious adverse reactions in patients receiving palbociclib plus letrozole were pulmonary embolism (3 of 83; 4%) and diarrhea (2 of 83; 2%).
The recommended dose and schedule of palbociclib is 125 mg daily for 21 consecutive days followed by 7 days off treatment with letrozole 2.5 mg daily continuously throughout the 28-day cycle.
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf

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