Lancet Oncology:个性化抗癌药疗效与传统治疗无差异,但专家仍看好
2015/09/20
随着基因组测序成本的下降,肿瘤学家开始研发以病人基因为靶标的昂贵新药。然而近日发表在《 Lancet Oncology》的研究表明,个性化抗癌药物的疗效与比传统治疗相比,并无多大差异。


随着基因组测序成本的下降,肿瘤学家开始研发以病人基因为靶标的昂贵新药。然而近日发表在《 Lancet Oncology》的研究表明,个性化抗癌药物的疗效与比传统治疗相比,并无多大差异。

芝加哥大学肿瘤学家Daniel Catenacci认为对个性化抗癌药物疗效的验证很重要,因为目前越来越多的肿瘤学家专注这领域。本研究第一作者,巴黎居里研究所肿瘤学家Christophe Le Tourneau表示,在现实生活中,未经过临床验证的试验很常见。同时他对此现象表示理解,因为病人想要存活而医生也想提供帮助。然而,给肿瘤基因突变患者以未获批的个性化药物治疗可使研究进入更好的临床阶段。

个性化抗癌药物疗效与传统治疗无差异

如今越来越多的个性化药物获批准用于治疗特定的癌症,但肿瘤学家希望这些药物对其他类型癌症也起作用。然而,超过30%的癌症药物未经过临床试验验证。

为了验证这些个性化药物的疗效,法国八个医院的研究人员分析患者肿瘤遗传或分子的异常状态。研究人员随机选出195名患者,其中部分患者接受针对性治疗,部分接受传统的化疗。调查结果发现,两种疗效没有显著差异。

休斯顿德克萨斯大学MD安德癌症研究中心的肿瘤学家Apostolia Tsimberidou表示,该研究证明了个性化医疗试验随机性的可行性。但在她看来,这次试验的设计比较糟糕,因为晚期疾病患者可能从个性化医疗中受益。同时她还表示,该试验没有选择最好的药物作为评估对象,并依赖于一个简单的方法来与癌症突变匹配。

本研究作者Le Tourneau承认这点,但他指出目前市场上还未出现更好的药物,且许多肿瘤学家运用同样简单的方法来在做个性化治疗决策。Catenacci也认为目前许多癌症医生在药物和病人匹配决策上做得不够。如果能准确将适合的药物匹配给合适的病人,那么精准医疗会变得更好。

个性化癌症试验

目前一些类似的试验正在进行中。在2012年,Tsimberidou报道了其临床试验的观察报告,该报告显示接受个性化治疗的患者比普通治疗受益更大。目前她正在进行样本量为1400的随机试验来验证该结果。

今年6月,美国国家癌症研究所宣布招募1000名志愿者来参与精准医疗项目,该项目名为 NCI-MATCH,在该项目中志愿者将根据肿瘤基因突变情况来接受20种药物治疗。美国临床肿瘤学会还推出了一个名为TAPUR的注册表,用于收集病人接受针对性抗癌药物的数据情况。

Catenacci说,如果有任何研究显示个性化抗癌药物对患者有效,无论这些药物是否获特定组织批准都会带来严重的监管挑战。Le Tourneau补充道,个性化医疗面临这些挑战只是时间上的问题。医生最终会根据患者肿瘤的遗传分子来量身定制治疗方案,而不是针对身体中的肿瘤组织。

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  • Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial

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