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安维汀联合希罗达显著延长HER2阴性乳腺癌总生存期

来源:生物谷 2014-09-28 13:24

 

2014年9月27日讯 /生物谷BIOON/ --安维汀(Avastin)是罗氏第二大畅销药,该药2013年全球销售额高达70亿美元,仅次于美罗华(Rituxan,89.20亿美元)。近日,2项III期研究表明,安维汀联合希罗达显著延长了HER2阴性乳腺癌患者的总生存期。

一项III期EMELDA研究,涉及185例经安维汀+多西紫杉醇化疗一线诱导治疗后病情得到稳定的HER2阴性转移性乳腺癌患者,研究中,将安维汀联合希罗达(Xeloda)化疗作为一种维持疗法,与安维汀单药疗法进行了疗效和安全性对比。数据表明,安维汀+Xeloda维持疗法显著改善了疾病无进展生存期(PFS:11.9个月 vs 4.3个月),使肿瘤恶化风险降低62%,数据具有统计学显著差异,达到了研究的主要终点。此外,该项研究还达到了总生存期(OS)次要终点,与安维汀单药治疗组相比,安维汀+希罗达维持治疗组总生存期显著延长(OS:39.0个月 vs 23.7个月),死亡风险降低57%。

另一项III期TANIA研究,涉及494例经安维汀+标准化疗治疗的HER2阴性转移性乳腺癌患者,研究中,将安维汀+标准化疗继续作为二线疗法对患者进行治疗。数据表明,与单独化疗相比,安维汀+化疗显著改善疾病无进展生存期(PFS:6.3个月 vs 4.2个月),使肿瘤恶化风险降低了25%,达到了研究的主要终点。(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.

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