在临床试验中报告侵袭性叶状乳腺癌:系统性审查
Karen Van Baelen1,2, Josephine Van Cauwenberge1,2, Marion Maetens1
1Laboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Leuven, Belgium.
NPJ breast cancer
|March 21, 2024
概括
侵袭性叶状乳腺癌 (ILC) 在临床试验中代表性不足,阻碍了治疗疗效的证据. 目前的试验标准,特别是RECIST v1.1,由于其独特的转移模式,未能充分包括ILC.
科学领域:
- 在瘤学瘤学.
- 临床试验研究 临床试验研究
- 乳腺癌亚型 乳腺癌亚型
背景情况:
- 与其他乳腺癌类型相比,侵入性叶状乳腺癌 (ILC) 呈现出明显的特征.
- 关于专门针对ILC的新疗法疗效的证据显著缺乏.
研究的目的:
- 评估ILC在乳腺癌新疗法III/IV期临床试验中的文档和表现.
- 评估ILC如何纳入,记录和分析临床试验数据.
主要方法:
- 通过PubMed和ClinicalTrials.gov.gov.gov识别的乳腺癌临床试验III/IV期的系统审查.
- 对试验纳入/排除标准的分析,重点关注组织学亚型和瘤可测性.
- 评估ILC包含率,中央病理报告和子组分析.
主要成果:
- 在93份经过审查的手稿中,有39份报告了与瘤可测度相关的包含限制.
- 在93份手稿中,只有13份记录了ILC收录率,该收录率在2.0%至26.0%之间.
- 没有任何试验报告了ILC的中心病理,13份手稿中只有3份包括ILC子组分析.
结论:
- 在临床试验中,ILC在很大程度上被忽视,代表性和文档性差.
- 目前的试验资格标准,包括RECIST v1.1,对于捕获ILC特征的不可测量的转移性模式是不充分的.
- 需要进一步的研究和修订的试验方法来改善ILC的代表性,并推进治疗疗效研究.
相关概念视频
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...