Department of Medical Oncology.
INSERM Unit U981. Gustave Roussy Cancer Campus. Villejuif. France.
Curr Opin Oncol. 2019 Nov;31(6):486-492. doi: 10.1097/CCO.0000000000000583.
Window of Opportunity (WOO) studies have gain their place in current clinical and translational research in breast cancer patients. This review provides current information and future applications of this specific type of research.
So far, WOO trials in breast cancer patients have demonstrated their utility in breast cancer research as: first they allow administering a treatment for a short period of time to treatment-naïve patients whose tumors have not developed mechanisms of resistance or heterogeneity because of previous therapies. Second, it brings a unique opportunity for translational research providing easy access to tumor tissue in order to evaluate antitumor effect from initial biopsy and from surgical resection specimen. They provide the perfect scenario for biomarker discovery and validation in an efficient and timely manner and valuable information about drug pharmacodynamics. Several issues need to be contemplated when designing and performing this type of trials including choice of a biological surrogate endpoint of efficacy as standard clinical activity endpoints are not feasible.
Despite some limitations like the absence of information about secondary mechanisms of resistance, WOO trials represent an important support for drug development and biomarker discovery in breast cancer patients.
机会之窗（WOO）研究在乳腺癌患者的临床和转化研究中占据了一席之地。本综述提供了此类特定研究的最新信息和未来应用。
迄今为止，乳腺癌患者的 WOO 试验已经证明了它们在乳腺癌研究中的实用性，例如：首先，它们允许在治疗前未经治疗的患者中短时间内给予治疗，这些患者的肿瘤由于先前的治疗而没有产生耐药性或异质性机制。其次，它为转化研究提供了独特的机会，可方便地获得肿瘤组织，以评估从初始活检和手术切除标本中的抗肿瘤作用。它们为生物标志物的发现和验证提供了一个高效、及时的理想环境，并提供了有关药物药效动力学的有价值信息。在设计和进行此类试验时，需要考虑一些问题，包括选择疗效的生物替代终点，因为标准的临床活动终点不可行。
尽管存在一些局限性，例如缺乏关于继发性耐药机制的信息，但 WOO 试验代表了支持乳腺癌患者药物开发和生物标志物发现的重要支撑。
