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赫赛汀对HER2阴性乳腺癌同样有用

作者:admin 发布时间:2015.02.15 浏览:

要害词:罗氏,赫赛汀,乳腺癌,HER2阴性

 

赫赛汀对HER2阴性乳腺癌同样有用

2014年9月27日讯 /生物谷BIOON/ --赫赛汀(Herceptin)是专门针对HER2阳性乳腺癌的分子靶向药物,自问世以来,为HER2阳性乳腺癌患者带来了庞大的保留起色,出格是用于术后帮助治疗时更是云云。HER2阳性乳腺癌约占全部乳腺癌病例的20%-25%。克日,罗氏发布的最新2项III期研究证明,赫赛汀帮助治疗对HER2阴性乳腺癌同样有用,该功效将会对HER2阴性乳腺癌的临床治疗发生起劲影响,并也许改变乳腺癌治疗近况。

赫赛汀(Herceptin,曲妥珠单抗)是罗氏第三大脱销药,该药2013年环球贩卖额高达68亿美元,仅次于美罗华(Rituxan,89.20亿美元)和安维汀(Avastin,贝伐单抗,70.37亿美元)。赫赛汀(Herceptin)欧洲和日本专利将于2014年到期,美国专利将于2015年到期。今朝,制药行业已经掀起了仿制潮。印度百康(Biocon)开拓的赫赛汀仿制药CANMAb估量将于2015年3月在印度上市,韩国Celltrion公司的赫赛汀仿制药Herzuma也于2014年头获韩国MFDS核准。

一项III期EMELDA研究,涉及185例经Herceptin+多西紫杉醇化疗一线诱导治疗后病情获得不变的HER2阴性转移性乳腺癌患者,研究中,将赫赛汀连系希罗达(Xeloda)化疗作为一种维持疗法,与赫赛汀单药疗法举办了疗效和安详性比拟。数据表白,Herceptin+Xeloda维持疗法明显改进了疾病无盼望保留期(PFS:11.9个月 vs 4.3个月),使肿瘤恶化风险低落62%,数据具有统计学明显差别,到达了研究的首要终点。另外,该项研究还到达了总保留期(OS)次要终点,与赫赛汀单药治疗组对比,赫赛汀+希罗达维持治疗组总保留期明显延迟(OS:39.0个月 vs 23.7个月),衰亡风险低落57%。

另一项III期TANIA研究,涉及494例经Herceptin+尺度化疗治疗的HER2阴性转移性乳腺癌患者,研究中,将Herceptin+尺度化疗继承作为二线疗法对患者举办治疗。数据表白,与单独化疗对比,Herceptin+化疗明显改进疾病无盼望保留期(PFS:6.3个月 vs 4.2个月),求医 看病 ,使肿瘤恶化风险低落了25%,到达了研究的首要终点。

乳腺癌临床治疗中,赫赛汀(Herceptin)是专门针对HER2阳性乳腺癌的分子靶向药物,该药是以癌细胞外貌的HER2分子为"靶点",通过阻断HER2分子克制并杀死肿瘤细胞。赫赛汀的发现,是乳腺癌治疗史上的里程碑,也是今朝海表里专家承以为治疗HER2阳性乳腺癌的基本用药。(生物谷Bioon.com)

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英文原文:Roche Avastin and  Xeloda show positive results in two label expansion clinical trials

Roche's (OTCQX:RHHBY) Avastin (bevacizumab) and Xeloda (capecitabine) achieve their primary endpoints in two Phase 3 clinical trials in HER2-negative metastatic breast cancer.

In the 185-patient IMELDA study, the safety and efficacy of maintenance treatment with Avastin plus Xeloda chemotherapy was compared to Avastin alone in patients with HER2-negative metastatic breast cancer that had not progressed during first-line induction treatment with Avastin plus docetaxel chemotherapy. The trial met its primary endpoint of improving progression-free survival (PFS) with a statistically significant 62% reduction in the risk of tumor progression in the Avastin plus Xeloda cohort compared the Avastin alone group (median PFS after induction: 11.9 months vs. 4.3 months). The study also hit its secondary endpoint of an improvement in overall survival (OS) with a statistically significant 57% reduction in the risk of death in the the Avastin plus Xeloda group compared to Avastin alone (median OS after induction: 39.0 months vs. 23.7 months).

The 494-patient TANIA study evaluated the safety and efficacy of Avastin as a second-line therapy in HER2-negative metastatic breast cancer patients treated with Avastin plus chemo as a first-line treatment. The trial met its primary endpoint of improving PFS in the second-line, significantly reducing the risk of tumor progression by 25% (median PFS: 6.3 months vs. 4.2 months).

The safety profiles in both trials were consistent with earlier studies.

Swiss drugmaker Roche said its cancer drug Avastin helped women with a common form of breast cancer live longer without their disease worsening, when used in combination with chemotherapy drug Xeloda.

Results of a Phase III study involving 185 patients with HER2-negative metastatic breast cancer found those treated with both drugs saw an almost threefold improvement in how long they lived without their disease getting worse compared with those taking Avastin alone.

A second late-stage trial with 494 patients who continued treatment with Avastin and standard chemotherapy after their disease had progressed showed patients lived significantly longer without the disease getting worse compared with those treated only with chemotherapy.

Roche said it would present full results of both studies at the European Society of Medical Oncology congress on Sept. 28.

(责任编辑:yixin.zhang)

赫赛汀对HER2阴性乳腺癌同样有用

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