Evolving or immutable - phase I solid tumor trials in the era of precision oncology.

IF 3 3区 医学 Q2 ONCOLOGY Investigational New Drugs Pub Date : 2024-06-01 Epub Date: 2024-05-22 DOI:10.1007/s10637-024-01445-z
Shannon S Stockton, G Dan Ayers, Cody Lee, Heather Laferriere, Satya Das, Jordan Berlin
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Abstract

In the era of precision oncology (PO), systemic therapies for patients (pts) with solid tumors have shifted from chemotherapy (CT) to targeted therapy (TT) and immunotherapy (IO). This systematic survey describes features of trials enrolling between 2010 and 2020, focusing on inclusion criteria, type of dose escalation scheme (DES) utilized, and use of expansion cohorts (ECs). A literature search identified phase I studies in adults with solid tumors published January 1, 2000- December 31, 2020 from 12 journals. We included only studies enrolling between 2010 and 2020 to better capture the PO era. Two reviewers abstracted data; a third established concordance. Of 10,744 studies, 10,195 were non-topical or enrolled prior to 2010; 437 studies were included. The most common drug classes were TT (47.6%), IO (22%), and CT (6.9%). In studies which reported race, patients were predominantly white (61.7%) or Asian (25.7%), followed by black (6.5%) or other (6.1%). Heterogeneity was observed in the reporting and specification of study inclusion criteria. Only 40.1% of studies utilized ECs, and among the studies which used ECS, 46.6% were defined by genomic selection. Rule-based DES were used in 89% of trials; a 3+3 design was used in 80.5%. Of all drugs tested, 37.5% advanced to phase II, while 10.3% garnered regulatory licensure (for an indication tested in phase I). In the era of PO, TT and IO have emerged as the most studied agents in phase I trials. Rule-based DES, which are more relevant for escalating CT, are still chiefly utilized.

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不断发展还是一成不变--精准肿瘤学时代的实体瘤 I 期试验。
在精准肿瘤学(PO)时代,实体瘤患者(pts)的全身疗法已从化疗(CT)转向靶向治疗(TT)和免疫疗法(IO)。本系统调查描述了2010年至2020年间入组试验的特点,重点关注纳入标准、采用的剂量递增方案(DES)类型以及扩增队列(EC)的使用。文献检索确定了12种期刊中2000年1月1日至2020年12月31日发表的针对成人实体瘤的I期研究。我们仅纳入了 2010 年至 2020 年间的研究,以更好地捕捉 PO 时代的研究。两名审稿人对数据进行了摘录;第三名审稿人确定了数据的一致性。在 10,744 项研究中,10,195 项为非局部用药或在 2010 年之前入选;437 项研究被纳入其中。最常见的药物类别是TT(47.6%)、IO(22%)和CT(6.9%)。在报告种族的研究中,患者主要是白人(61.7%)或亚裔(25.7%),其次是黑人(6.5%)或其他种族(6.1%)。在研究纳入标准的报告和说明方面存在异质性。只有40.1%的研究使用了EC,而在使用ECS的研究中,46.6%是通过基因组选择定义的。89%的试验采用了基于规则的DES;80.5%的试验采用了3+3设计。在所有试验药物中,37.5%的药物进入了II期,10.3%的药物获得了监管部门的许可(针对I期试验的适应症)。在 PO 时代,TT 和 IO 已成为 I 期试验中研究最多的药物。基于规则的 DES 更适用于 CT 的升级,但仍主要用于 CT 的升级。
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来源期刊
CiteScore
7.60
自引率
0.00%
发文量
121
审稿时长
1 months
期刊介绍: The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.
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