Challenges in biomarker-based clinical trials for patients with gastrointestinal malignancies

IF 1 Q4 PHARMACOLOGY & PHARMACY
J. Kratz, Wei Zhang, M. Patel, N. Uboha
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引用次数: 0

Abstract

ABSTRACT Introduction The goal of precision oncology is to match each patient with the most appropriate therapeutic agent based on patient- and tumor-specific characteristics. Many therapeutics in development target tumors with specific biomarkers, in addition to considering tumor histologic classification and clinical presentation. Areas Covered Appropriate patient selection for research studies is critical to elucidate the potential effectiveness of therapies in development, as well as to spare the toxicities from ineffective therapies in patients who are unlikely to benefit. Biomarker-based clinical studies provide a platform to bring forward the expanse of therapeutics beyond the use of chemotherapy, including novel immunotherapeutic and targeted strategies. There are a number of issues to be considered when developing these types of studies. They range from biomarker validity to patient enrollment and trial availability. In this review, we discuss challenges that are frequently confronted in the design, enrollment, and analysis of biomarker-based clinical trials for patients with gastrointestinal (GI) cancers. Expert opinion The challenges encountered in biomarker-based trials for patients with GI cancers must be considered and addressed early during drug development to ensure proper therapy and patient selection in a timeframe acceptable for both patient diseases and rapidly changing oncology standards.
基于生物标志物的胃肠道恶性肿瘤临床试验面临的挑战
精确肿瘤学的目标是根据患者和肿瘤的特异性特征为每位患者匹配最合适的治疗剂。除了考虑肿瘤的组织学分类和临床表现外,发展中的许多治疗方法都针对具有特定生物标志物的肿瘤。适当的患者选择对于阐明开发中的治疗方法的潜在有效性以及避免对不太可能受益的患者进行无效治疗的毒性至关重要。基于生物标志物的临床研究提供了一个平台,以推动化疗之外的治疗方法的扩展,包括新的免疫治疗和靶向策略。在开展这类研究时,有许多问题需要考虑。它们的范围从生物标志物有效性到患者登记和试验可用性。在这篇综述中,我们讨论了在针对胃肠道(GI)癌症患者的基于生物标志物的临床试验的设计、入组和分析中经常面临的挑战。在针对胃肠道癌症患者的基于生物标志物的试验中遇到的挑战必须在药物开发的早期考虑和解决,以确保在患者疾病和快速变化的肿瘤学标准可接受的时间范围内进行适当的治疗和患者选择。
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来源期刊
CiteScore
2.30
自引率
0.00%
发文量
9
期刊介绍: Expert Review of Precision Medicine and Drug Development publishes primarily review articles covering the development and clinical application of medicine to be used in a personalized therapy setting; in addition, the journal also publishes original research and commentary-style articles. In an era where medicine is recognizing that a one-size-fits-all approach is not always appropriate, it has become necessary to identify patients responsive to treatments and treat patient populations using a tailored approach. Areas covered include: Development and application of drugs targeted to specific genotypes and populations, as well as advanced diagnostic technologies and significant biomarkers that aid in this. Clinical trials and case studies within personalized therapy and drug development. Screening, prediction and prevention of disease, prediction of adverse events, treatment monitoring, effects of metabolomics and microbiomics on treatment. Secondary population research, genome-wide association studies, disease–gene association studies, personal genome technologies. Ethical and cost–benefit issues, the impact to healthcare and business infrastructure, and regulatory issues.
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