Stivarga提高OS的肝癌患者

StephenW

Stivarga improves OS for unresectable HCC
June 29, 2016

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Recent data from the RESORCE clinical trial presented at the European Society of Medical Oncology 18th World Congress on Gastrointestinal Cancer showed Stivarga was safe and improved overall survival for patients with unresectable hepatocellular carcinoma.
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“The global incidence of liver cancer continues to increase and has more than tripled in the United States over the last three decades, and currently there are no proven or approved systemic second-line treatment options for patients with advanced HCC,” Jordi Bruix, MD, head of the Barcelona Liver Clinic Group, Hospital Clinic, University of Barcelona, Spain, and trial investigator, said in a press release. “The improvement in overall survival seen with [Stivarga] in the RESORCE study signals the addition of a potential option in this treatment setting.”

Jordi Bruix, MD

Jordi Bruix

Bruix and colleagues randomly assigned 573 patients with unresectable HCC whose disease progressed after treatment with Nexavar (sorafenib, Bayer HealthCare) to treatment with either 160 mg of Stivarga (regorafenib, Bayer; n = 379) for 3 weeks on and 1 week off, or placebo (n = 194) with 28 days constituting one full treatment cycle.

Results showed patients treated with regorafenib had a longer median overall survival (OS) of 10.6 months compared with 7.8 months for patients treated with placebo plus best supportive care (HR = 0.62; 95% CI, 0.5-0.78). The median progression-free survival was 3.1 months in the regorafenib-treated group compared with 1.5 months in the control group (HR = 0.46; 95% CI, 0.37‒0.56).

Disease control rate defined by mRECIST criteria was 65.2% in regorafenib-treated patients compared with the placebo group (36.1%; P < .001). The overall response rate (complete and partial) was 10.6% vs. 4.1% (P = .005).

More patients in the regorafenib-treated group experienced grade 3 adverse events (79.7%) compared with placebo (58.5%). Common grade 3 adverse events included hypertension, hand-foot skin reaction, fatigue and diarrhea. Approximately 68% of patients treated with regorafenib underwent dose modification due to adverse events compared with 31.1% of patients treated with placebo.

Patients treated with placebo had a higher mortality rate compared with regorafenib-treated patients after 30 days post-treatment (19.7% vs. 13.4%).

Bayer plans to submit data from the RESORCE study for marketing authorization of regorafenib for the treatment of unresectable HCC in the U.S. and worldwide later this year, according to the press release.

The researchers concluded: “Regorafenib significantly improved OS in patients with HCC who progressed during treatment with sorafenib. Adverse events were consistent with the known safety profile of regorafenib.” – by Melinda Stevens

Reference:

Bruix J, et al. Abstract #LBA-03. Presented at: European Society of Medical Oncology World Congress on Gastrointestinal Cancer; June 29-July 2, 2016; Barcelona, Spain.

Disclosure: Bruix reports consulting for AbbVie, Arqule, Bayer, Boehring

StephenW

Stivarga提高OS的肝癌患者
2016年6月29日

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从上消化道肿瘤医学肿瘤学第18届世界大会的欧洲社会提出的RESORCE临床试验的最新数据显示，Stivarga是治疗晚期肝癌安全，提高整体生存。
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“肝癌的全球发病率的不断增加，已超过美国在过去的三十年中翻了三倍，目前有没有证实或批准的系统性二线治疗方案治疗晚期肝癌，”尔迪Bruix，MD ，巴塞罗那肝诊疗组，医院门诊，巴塞罗那，西班牙和试验调查大学的头一份新闻稿中说。 “在[Stivarga]在RESORCE研究中发现总生存期的改善信号加在这个处理设置一个潜在的选项。”

霍尔迪Bruix，MD

霍尔迪Bruix

Bruix和同事随机分配573例肝癌患者，其疾病的治疗后进展与多吉美（索拉非尼，拜耳医药保健），以治疗或者160毫克Stivarga的（regorafenib，拜耳; N = 379），3周在1周了，还是安慰剂（n = 194）与构成一个完整的治疗周期28天。

结果表明，随着regorafenib治疗的患者为10​​.6个月，更长的中位总生存期（OS）7.8个月，与安慰剂加最佳支持治疗的患者相比（HR = 0.62; 95％CI，0.5-0.78）。 （; 95％CI，0.37-0.56 HR = 0.46）与对照组1.5三个月的数字比较中位无进展生存期是regorafenib治疗组3.1个月。

通过mRECIST标准定义的疾病控制率在regorafenib治疗的患者为65.2％，与安慰剂组相比（36.1％，P <0.001）。总体反应率（完全和部分）为10.6％和4.1％（P = 0.005）。

更多的患者的regorafenib治疗组经历等级与安慰剂（58.5％）相比，3不良事件（79.7％）。常见的3级不良反应包括高血压，手足皮肤反应，乏力，腹泻等。与regorafenib治疗的患者约68％接受剂量调整由于与用安慰剂治疗的患者为31.1％相比，不良事件。

30天治疗后（19.7％对13.4％）之后regorafenib治疗的患者相比，使用安慰剂治疗的患者有较高的死亡率。

拜耳计划从RESORCE研究今年提交数据regorafenib的营销授权在美国之后的治疗不能切除肝癌和世界各地，根据新闻稿。

研究人员得出结论：“在HCC患者索拉非尼治疗过程中谁进步Regorafenib显著改善OS。不良事件的发生与regorafenib的已知安全性一致的。“ - 由梅琳达·史蒂文斯

参考：

Bruix J，等。摘要＃LBA-03。发表在：上消化道肿瘤医学肿瘤学世界大会的欧洲社会; 6月29日至七月2日，2016年西班牙巴塞罗那。

披露：Bruix咨询报告为艾伯维，ARQULE，拜耳，Boehring