ASCO 2016：赫赛汀生物仿制药或可有效治疗HER2阳性的乳腺癌患者

图片来源：medicalxpress.com

近日，一项发表于美国临床肿瘤学会年会上的研究报告中，来自加利福尼亚大学的研究人员通过研究发现，一种廉价且同赫赛汀相似的药物或对恶性HER2阳性的乳腺癌患者的治疗效果同赫赛汀的治疗效果一样。赫赛汀（注射用曲妥珠单抗）是一种适用于治疗HER2 过度表达的转移性乳腺癌的药物。

HER2阳性的乳腺癌包括许多特殊的基因，这些基因和肿瘤快速生长及患者预后较差直接相关。这种作用HER2阳性乳腺癌的新型药物是一种类似于赫赛汀的生物仿制药(biosimilar drug)，生物仿制药往往是模仿品牌药而开发出来的，而其在治疗患者的效果上同品牌药几乎一样。

研究人员进行了一项随机的临床III期试验，来检测和赫赛汀相似的药物MYL-1401O在治疗乳腺癌上的效果，这项试验研究者招募了500名患者，分布在非洲、亚洲、欧洲及拉丁美洲等95个地方进行。在试验中，患者接受化疗方法和赫赛汀或药物MYL-1401O进行治疗，试验至少进行8个循环，直到单独使用赫赛汀发现患者的疾病会进展为止。

6个月过后，研究者发现，所有研究对象的反应率几乎相差无几，MYL-1401O治疗组患者的反应率为70%，而赫赛汀治疗组为64%；同样的两组研究对象产生严重副作用的比率也相似，MYL-1401O治疗组为38%，赫赛汀治疗组为36%；最常见的副作用就是患者机体中白细胞计数降低，研究者指出，两组研究对象的心脏功能并无差异，在每组研究对象中均有4名患者因治疗而死亡。

药物赫赛汀可以明显改善HER2阳性的乳腺癌患者的生存率，但由于该药物价格非常昂贵导致全球很多患者并不能因此而获益；这项试验也是研究人员进行的首个临床试验来揭示赫赛汀生物仿制药在治疗HER2阳性乳腺癌具有同赫赛汀一样的效果。研究人员希望生物仿制药的引入可以扩大患者获取有效药物的途径，而这对于改善全球数以千计的癌症患者的健康和生存率或将带来极大帮助。

原始出处：

Cheaper breast cancer drug does well in clinical trial

For women with advanced HER2-positive breast cancer, a similar but less expensive experimental drug works just as well as the standard drug Herceptin (trastuzumab), a new study finds.

HER2-positive tumors contain certain genes that are associated with more rapid tumor growth and a worse prognosis, according to the American Cancer Society.

The new drug targeting these tumors is what's known as a biosimilar drug—in this case, a drug similar to Herceptin. Biosimilars are designed to mimic the brand-name medicine, and are expected to produce roughly the same results in patients, the U.S. Food and Drug Administration explained.

Researchers conducted a randomized phase III clinical trial of the biosimilar trastuzumab antibody drug MYL-1401O. Their trial included 500 patients. The trial was conducted at 95 sites in Africa, Asia, Europe and Latin America.

The women received chemotherapy and either Herceptin or MYL-1401O for at least eight cycles, followed by Herceptin alone until their disease progressed.

Six months later, response rates were similar in both groups, 70 percent with MYL-1401O and 64 percent with Herceptin, the study found.

Rates of serious side effects were also similar—36 percent in the Herceptin group and 38 percent in the MYL-1401O group. The most common serious side effect was a low white blood cell count. There was no difference in measures of heart function between the two groups. There were four treatment-related deaths in each group, the researchers reported......

更多ASCO 2016的最新内容，请点击此处进入“ASCO 2016”专题。