Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents
Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents
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DOI：
10.1158/1078-0432.ccr-16-1367
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发表时间：
2017-01-01
影响因子：
11.5
通讯作者：
Reaman, Gregory H.
中科院分区：
文献类型：
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作者：
Chuk, Meredith K.;Mulugeta, Yeruk;Reaman, Gregory H.
在临床试验中，青少年癌症患者的入组率远低于年轻儿科患者。对于患有“成人型”癌症的青少年，缺乏相关试验被认为是造成这种差异的原因之一。青少年通常没有资格参加成人肿瘤学试验，许多药物的初始儿科试验是在药物获得批准后数年才进行的。因此，由于标签外使用，这些试验的青少年招募可能会很慢，在最初批准时缺乏前瞻性收集的安全性和疗效数据，最重要的是，这些青少年延迟了获得有效治疗的机会。为了促进青少年癌症患者更早获得研究药物和获批药物，并且由于青少年和成人的药物暴露通常相似，我们建议将青少年（12-17岁）纳入疾病和目标适当的成人肿瘤学试验。这种方法需要仔细监测任何不同的安全性信号，适当的药代动力学评价，并确保符合伦理要求。将青少年纳入成人肿瘤学试验将需要研究者、合作团体、行业、机构审查委员会和监管机构的合作，以克服真实的和感知的障碍。(C)2016年AACR。
The enrollment of adolescents with cancer in clinical trials is much lower than that of younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment in adult oncology trials, and initial pediatric trials for many drugs are conducted years later, often after the drug is approved. As a result, accrual of adolescents to these trials may be slow due to off-label use, prospectively collected safety and efficacy data are lacking at the time of initial approval, and, most importantly, these adolescents have delayed access to effective therapies. To facilitate earlier access to investigational and approved drugs for adolescent patients with cancer, and because drug exposure is most often similar in adolescents and adults, we recommend the inclusion of adolescents (ages 12-17) in disease-and target-appropriate adult oncology trials. This approach requires careful monitoring for any differential safety signals, appropriate pharmacokinetic evaluations, and ensuring that ethical requirements are met. Inclusion of adolescents in adult oncology trials will require the cooperation of investigators, cooperative groups, industry, institutional review boards, and regulatory agencies to overcome real and perceived barriers. (C) 2016 AACR.