ASCO 2014:“界定”抗癌药物研发的“临床价值”

2014-06-04 王迈 中国医学论坛报

第50届美国临床肿瘤学会年会(ASCO2014)于2014年5月30日至6月3日在美国芝加哥召开。 ASCO">ASCO组织专门委员会,“界定”抗癌药物研发的“临床价值” 芝加哥当地时间6月2日(周一)上午举行的ASCO/ECCO(欧洲癌症组织)联席会议上,与会者将关注的话题是“价值与癌症治疗(Value and Cancer Care)”。 在今年的ASCO年会上,“

第50届美国临床肿瘤学会年会(ASCO2014)于2014年5月30日至6月3日在美国芝加哥召开。

ASCO">ASCO组织专门委员会,“界定”抗癌药物研发的“临床价值”

芝加哥当地时间6月2日(周一)上午举行的ASCO/ECCO(欧洲癌症组织)联席会议上,与会者将关注的话题是“价值与癌症治疗(Value and Cancer Care)”。

在今年的ASCO年会上,“癌症治疗的社会价值”这一主线贯穿会议设置的始终,可以说是大会主题“科学与社会”的最好背书。正如ASCO教育委员会主席GiniF.Flemming医生和科学项目会员会主席Jedd D. Wolchok医生在会议亮点推荐时所说:“我们的责任不仅是呈现科报告最新的临床进展,还应重视这些治疗对社会整体的价值所在。”(详见5月30日“CMT肿瘤”微信)

在周一的ASCO/ECCO联席会议上,美国Harvard大学医学院血液科-肿瘤科主任Lowell E. Schnipper医生将于进行题为“American Perspective on Globally Defining Value in Cancer Care(全球癌症治疗价值定义的美国视角)”的发言。之前,Schnipper医生在《ASCO每日新闻》上撰文,表达了他对当前肿瘤药物临床研究的价值取向的忧虑,并表示“研究中有临床意义的结果(clinically meaningful outcomes,CMO)是实现高价值的癌症治疗(high-value cancer care)的关键步骤”。


Lowell E. Schnipper

Schnipper医生在稍具批判性的撰文中提到,尽管我们对癌症生物学的了解已经得到极大的进步,然而,治愈晚期癌症的“突破(breakthrough)性”药物研发进程却令人失望。象伊马替尼和曲妥珠单抗这样具有“高效能(high impact)”的药物少之又少。而一些药物仅能轻微延长生存,却带来附加的毒性和巨大的经济负担。在过去的几年间,美国FDA批准了大量新型抗癌药物,而其中大部分,与原有的标准疗法相比,如果说有效,也仅是延长很少的数月生存。但是,这些新药的花费,却是每月5000~7000美元。(对此)我们必须找到一个方法做得更好。而在现今的分子肿瘤学时代,(为药物研究的有效性)设定一个更高的目标是可行的。

正是为了应对这样的挑战,ASCO倡议“界定临床研究中的有临床意义的结果(to define ClincialMeaningful Outcomes in clinical trails)”,并由ASCO癌症研究委员会发起这项工作。委员会召集临床肿瘤学家、临床研究者、生物统计学家和患者代表,共同讨论用于晚期癌症研究管理的方案。而每组人员的工作是,基于与现有方案比较是否有临床临床意义,对特定患者群的治疗,界定临床研究的差异幅度(the magnitude of difference)。

“这些说起来很容易,但是在目前的医疗服务资助、药物市场研发以及审批和销售的大环境下,执行面临着很大的困难。”但是,Schnipper医生仍坚信“彻底的改变是不可避免的,而我们必须要投入到这场争论中去。”

部分信息来源于ASCO网站


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    2015-02-27 quxin068
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    2014-06-06 lqvr
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    2014-06-06 sunylz

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