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Sorafenib是后期肝癌的新首选治疗

来源:医源世界 作者:Allison Gandey 2007-7-10
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摘要: June 11, 2007(芝加哥讯)-Onyx药厂的sorafenib(Nexavar)是第一个使用于后期肝癌有效的治疗。英国伯明罕大学研究试验机构的Philip Johnson医师在发表会后讨论时间表示,这是肝癌治疗新纪元的黎明,但是他也提醒就像新一天的黎明,我们直到太阳升起之后才能看得清楚。 在一项简短发表试验结果的记者会中,座谈会引言......


  June 11, 2007(芝加哥讯)-Onyx药厂的sorafenib(Nexavar)是第一个使用于后期肝癌有效的治疗;根据发表于美国临床肿瘤学会第43届年会上的研究,标靶多磷酸酶抑制剂可以延长存活时间达44%;英国伯明罕大学研究试验机构的Philip Johnson医师在发表会后讨论时间表示,这是肝癌治疗新纪元的黎明,但是他也提醒就像新一天的黎明,我们直到太阳升起之后才能看得清楚。
  
  在一项简短发表试验结果的记者会中,座谈会引言人北卡罗莱纳州温斯顿-赛伦Wake Forest大学医学院William Blackstock医师对于这些新的试验非常热心;Blackstock医师向Medscape表示,这是一个无法在美国进行的临床试验例子,癌症病患在这里无法接受安慰剂治疗,就像这个研究中的一样,他们期待被治疗。
  
  他表示,除了提供难以治疗病患一个第一线治疗之外,这些来自西班牙的研究结果将会对未来的肝癌研究造成深远的影响;Blackstock医师表示,我无法告诉你未来这些研究的设计将会是如何,但是我可以告诉你控制组将会是sorafenib。
  
  【未来临床试验的新参照标准】
  主要研究者纽约Mount Sinai医学院、以及西班牙巴赛隆纳August Pi i Sunyer医院生物医学研究机构Josep Llovet医师向会议与会者表示,sorafenib是肝癌病患全身性治疗的新参照标准。
  
  Blackstock医师向记者表示,Llovet医师为我们所做的是建立一个基准点,现在我们对于肝癌可以到达一个前所未有的境界。
  
  目前为止,对于后期肝癌患者并没有标准照护;Doxorubicin被报导是最广为使用的药物,尽管仅有一个收纳60位病患的研究支持这样的用法,且该药物可能有25%发生致命性并发症的风险;Mitoxantrone被核准使用于肝癌治疗,但并不是黄金标准。
  
  在这项国际间第三期、双盲、安慰剂控制研究,研究者收纳602位病患,这项名为 SHARP (the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol)的研究,试验终点为整体存活率与试验后有症状恶化所需时间,病患每天口服2次每次400 mg的sorafenib,或是安慰剂为期6个月,但是该试验因为试验结果正面而提早结束。
  
  固体肿瘤的反应评估条件

结果
Sorafenib (n=299)
安慰剂(n=303)
完全反应
0
0
部份反应 , n (%)
7 (2.3)
2 (0.7)
疾病稳定 , n (%)
211 (71)
204 (67)
疾病恶化 , n (%)
54 (18)
73 (24)
4 个月后疾病未恶化率
62%
42%
治疗时间(中位数)
23 周
19 周

  毒性
结果
Sorafenib (n=299)
Placebo (n=303)
52
54
腹泻
11
2
手足皮肤反应
8
1
出血
6
9

  Llovet医师表示,恶化所需中位数时间为24周相较于12周(危险比值为0.58;P=0.000007),这代表恶化所需时间延长了73%。
  
  在发表会后的讨论时间,Johnson医师指出美国肝癌的发生率持续上升;发生肝癌的危险因子包括慢性B型与C型肝炎;全世界,有60%至80%的肝癌病例与B型肝炎有关;由于这可以透过新生儿注射疫苗预防,或以抗病毒药物治疗,Johnson医师表示应该把重点放在预防上。
  
  但对于那些需要治疗的病患而言,Llovet医师表示,sorafenib每个月的费用高达5000块美金,与欧盟的价格大致相同;Johnson医师表示这个价格在世界上许多地方将会是个障碍,但Blackstock医师对于价格的问题并不是那么关心,他表示,因为目前为止没有其他取代用药,他不认为药价是个主要的障碍。
  
  由于sorafenib的耐受性良好,Blackstock医师计划可以针对肝功能更差的病患进行研究;其他有潜力的药物包括bevacizumab、erlotinib与sunitinib。

Sorafenib New First-Line Option for Advanced Liver Cancer
By Allison Gandey
Medscape Medical News

 

June 11, 2007 (Chicago) — Onyx Pharmaceuticals' sorafenib (Nexavar) is the first effective systemic treatment for advanced liver cancer. Presenting here at the 43rd annual meeting of the American Society of Clinical Oncology, researchers showed that the targeted multikinase inhibitor extends survival by 44%. "This improvement is dramatic," Philip Johnson, MD, from the Institute for Cancer Studies at the University of Birmingham, in the United Kingdom, said during a discussion period following the presentation. "This is the dawn of a new era for hepatocellular carcinoma therapy," he said, but he also cautioned that just like at the dawn of a new day, "we can't necessarily see everything until the light shines."
During a press briefing outlining the findings, session moderator William Blackstock, MD, from the Wake Forest University School of Medicine, in Winston-Salem, North Carolina, was very enthusiastic about the new trial. "This is an example of a study that couldn't have been done in the United States," Dr. Blackstock told Medscape. "Cancer patients here would never have accepted a placebo arm like the one in this trial. They expect to be treated."
He said that in addition to providing a first-line option for difficult-to-treat patients, these findings out of Spain will revolutionize future liver cancer clinical trials. "I can't tell you what the design will be for these trials," Dr. Blackstock said, "but I can tell you what the control will be — sorafenib."
New Reference Standard for Future Clinical Trials
Lead investigator Josep Llovet, MD, from the Mount Sinai School of Medicine, in New York, and the Institut d'Investigacions Biomediques August Pi i Sunyer Hospital Clinic, in Barcelona, Spain, told delegates at the meeting that sorafenib is the new reference standard for systemic therapy of hepatocellular carcinoma patients.
"What Dr. Llovet has done for us establishes a baseline, a platform," Dr. Blackstock told reporters. "Now we can move forward in hepatocellular carcinoma in a way that was not possible before."
There is currently no widely accepted standard of care for advanced liver cancer. Doxorubicin is reportedly the most widely used agent, despite the fact that only 1 randomized controlled trial of 60 patients has supported its use and the drug is said to have a 25% rate of fatal complications. Mitoxantrone is licensed for hepatocellular carcinoma but is not considered a gold standard.
In this international phase 3, double blind, randomized, placebo-controlled trial, investigators studied 602 patients. The trial, known as the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP), looked at the primary end points of overall survival and time to symptomatic progression. Patients received oral sorafenib 400 mg twice daily or placebo for 6 months, but the trial was stopped early because the findings were so positive.

Response Evaluation Criteria in Solid Tumors

Outcome Sorafenib (n=299) Placebo (n=303)
Complete response 0 0
Partial response, n (%) 7 (2.3) 2 (0.7)
Stable disease, n (%) 211 (71) 204 (67)
Progressive disease, n (%) 54 (18) 73 (24)
Progression-free rate at 4 months 62% 42%
Duration of treatment (median) 23 weeks 19 weeks

Toxicity

Outcome Sorafenib (n=299) Placebo (n=303)
Serious adverse events 52 54
Diarrhea 11 2
Hand-foot skin reactions 8 1
Bleeding 6 9

Dr. Llovet reported that the median time to progression was 24 weeks vs 12 weeks (hazard ratio, 0.58; = 0.000007). This represented a 73% prolongation in time to progression.
During the discussion period following the presentation of the findings, Dr. Johnson noted that the incidence of hepatocellular carcinoma is rising in the United States. Risk factors for hepatocellular carcinoma include chronic viral hepatitis types B and C. Worldwide, hepatitis B is said to be responsible for 60% to 80% of all hepatocellular carcinoma cases. Because it is preventable by immunization at birth and antiviral treatment, Dr. Johnson pointed out that scarce resources should be focused on prevention.
But for those requiring treatment, Dr. Llovet said sorafenib costs $5000 per month, roughly the same as it costs in the European Union. Dr. Johnson noted that cost will be a barrier in many parts of the world. Dr. Blackstock was less concerned about the price point: "Given that there are no alternatives at this time, I don't see cost as a major barrier."
Because sorafenib was so well tolerated, Dr. Blackstock proposed that it be studied in patients with more compromised liver function. Other targeted agents in the wings for liver cancer include bevacizumab, erlotinib, and sunitinib.
ASCO 43rd Annual Meeting. Late-breaking abstract 1. Presented June 4, 2007.

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