Tărăbuță Paul Adrian
Department of Science and Engineering of Oxide Materials and Nanomaterials, Faculty of Chemical Engineering and Biotechnologies, National University of Science and Technology Politehnica Bucharest, 1-7 Gh. Polizu Street, 011061 Bucharest, Romania; National Centre for Micro and Nanomaterials and National Centre for Food Safety, National University of Science and Technology Politehnica Bucharest, 313 Splaiul Independenței, 060042 Bucharest, Romania.
Biomater Adv. 2025 Dec;177:214365. doi: 10.1016/j.bioadv.2025.214365. Epub 2025 Jun 3.
In the context of an increasing cancer burden, drug delivery systems (DDSs) emerged as promising alternatives to stand-alone drugs. This review aimed to identify clinically approved oncologic DDSs and briefly discuss aspects relevant to the clinical landscape. Sixty oncologic DDSs that received regulatory approval are included, with an inclusion criterion being the existence of information on length scale. Primary data sources include journal articles and gray literature. Secondary data sources include books and review articles. Early on, ambiguities regarding key oncology and drug delivery terms are tackled. Then, the length scales (macro-, micro- and nano-) and delivery phenomena are delineated. Four targeting mechanisms are presented. No oncologic DDS capable of active targeting has been approved. The DDSs approved for oncology are evaluated, with emphasis on their chemistry and clinical performance. Using two geometrical methods, new data on the size of nineteen molecular medicines is provided. The reasons behind the five withdrawals known for oncologic DDSs are investigated. Challenges for oncologic DDSs are identified. Strategies to improve tumor targeting are systematized. Alternative applications in cancer therapy are suggested. The success of an oncologic DDS depends on whether therapeutic, manufacturing and economic requirements are met. Though the trend of oncology approvals favors the nanoscale in absolute numbers, relative numbers favor the micro- and macroscales. Proposals made to improve the rate of clinical translation are to test the clinical benefit of promising, yet insufficiently investigated, designs, and to reorient those DDSs that failed in clinical trials toward new avenues in oncotherapy.
在癌症负担日益加重的背景下，药物递送系统（DDSs）成为独立药物的有前景的替代方案。本综述旨在识别临床批准的肿瘤学DDSs，并简要讨论与临床情况相关的方面。纳入了60种获得监管批准的肿瘤学DDSs，纳入标准是存在关于长度尺度的信息。主要数据来源包括期刊文章和灰色文献。次要数据来源包括书籍和综述文章。早期解决了关于关键肿瘤学和药物递送术语的模糊性。然后，描述了长度尺度（宏观、微观和纳米）和递送现象。介绍了四种靶向机制。尚无能够主动靶向的肿瘤学DDS获得批准。对批准用于肿瘤学的DDSs进行了评估，重点是它们的化学性质和临床性能。使用两种几何方法，提供了19种分子药物大小的新数据。调查了肿瘤学DDSs已知的五次撤市背后的原因。确定了肿瘤学DDSs面临的挑战。系统化了改善肿瘤靶向的策略。提出了癌症治疗中的替代应用。肿瘤学DDS的成功取决于是否满足治疗、制造和经济要求。尽管肿瘤学批准的趋势在绝对数量上有利于纳米尺度，但相对数量有利于微观和宏观尺度。为提高临床转化速率提出的建议是测试有前景但研究不足的设计的临床益处，并将那些在临床试验中失败的DDS重新导向肿瘤治疗的新途径。
