医学
临床试验
乳腺癌
观察研究
肿瘤科
微小残留病
生物标志物
代理终结点
疾病
重症监护医学
内科学
循环肿瘤DNA
癌症
生物化学
化学
白血病
作者
Carmine Valenza,Dario Trapani,Giuseppe Curigliano
出处
期刊:Current Opinion in Oncology
[Ovid Technologies (Wolters Kluwer)]
日期:2022-09-07
卷期号:34 (6): 595-605
被引量:4
标识
DOI:10.1097/cco.0000000000000905
摘要
Longitudinal evaluation of circulating tumour DNA (ctDNA) represents a promising tool for monitoring tumour evolution. In patients with breast cancer, ctDNA dynamics for the assessment of molecular residual disease (MRD) and resistances may, respectively, help clinicians in treatment modulation of adjuvant treatments, and in anticipating resistance to ongoing treatments and switch treatments before clinical progression, to improve disease control. Anyway, the introduction of this dynamic biomarker into clinical practice requires the demonstration of analytical validity, clinical validity and clinical utility.In early breast cancer setting, several observational studies demonstrated the clinical validity of MRD monitoring through ctDNA in identifying patients at a higher risk of relapse, but many clinical trials evaluating the clinical utility are still ongoing, and few data resulted in inconclusive results.Instead, ctDNA dynamics for intercepting resistance have not been fully evaluated in terms of clinical validity, because monitoring schedules of most observational studies are not intensive. The only trial assessing their clinical utility (PADA-1) demonstrated a benefit in terms of progression-free survival, portraying a new landscape for clinical trials in this space.Rigorous clinical trials with adequate assays and patient-relevant endpoints are paramount to demonstrate the clinical utility of ctDNA dynamics and eventually increase clinical outcomes.
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