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癌症纳米药物的随机III期临床试验概述。

An overview of randomized phase III clinical trials of cancer nanomedicines.

作者信息

Melo Micael N, Amaral Ricardo G, Melo de Andrade Lucas R, Severino Patricia, Blanco-Llamero Cristina, Andrade Luciana N, Souto Eliana B

机构信息

Department of Medicine, Federal University of Sergipe, Lagarto, Sergipe 49400-000, Brazil.

Department of Physiology, Federal University of Sergipe, São Cristóvão, Sergipe 49100-000, Brazil.

出版信息

Cancer Pathog Ther. 2024 Oct 28;3(4):322-336. doi: 10.1016/j.cpt.2024.10.001. eCollection 2025 Jul.


DOI:10.1016/j.cpt.2024.10.001
PMID:40697515
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12277848/
Abstract

BACKGROUND: Cancer therapy has undergone significant advances in recent decades attributed to personalized medicine and targeted drug delivery. Among the promising approaches, the use of nano-based delivery systems has become a relevant approach capable of improving treatment by releasing antineoplastic drugs at the target site, improving therapeutic efficacy, minimizing cytotoxicity in healthy tissues, and ultimately, reducing the intensity of adverse effects of chemotherapy. This study prospectively evaluated the impact of formulating anti-neoplastic drugs as nanomedicines on clinical response, overall survival, safety, and quality of life of cancer patients, based on the outcomes of randomized clinical trials. METHODS: A literature review was carried out by systematically searching the PubMed/MEDical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), and Latin American and Caribbean Health Sciences Literature (LILACS) databases for phase III clinical trials, comparing nanomedicines with conventional therapies for the treatment of various cancer types. RESULTS: The nanomedicines analyzed were those that are approved and used in Brazil, considering the country's emerging market for advanced cancer treatments. From a total of 303 articles found, 26 articles were selected for systematic review. Studies showed that PEGylated l-asparaginase achieved a similar therapeutic effect to that of l-asparaginase, with fewer applications due to its longer half-life. Paclitaxel bound to albumin improved therapeutic efficacy as well as reduced infusion time and solvent-related toxicity of the conventional paclitaxel formulation. PEGylated liposomal doxorubicin showed better pharmacokinetics, reduced cardiotoxicity, and improved quality of life in cancer patients compared to that of free doxorubicin. CONCLUSIONS: This study reinforces the scientific evidence of the added value of nanomedicines to improve therapeutic efficacy and reduce toxicity in patients under chemotherapy.

摘要

背景:近几十年来,由于个性化医疗和靶向药物递送,癌症治疗取得了重大进展。在众多有前景的方法中,基于纳米的递送系统已成为一种相关方法,能够通过在靶位点释放抗肿瘤药物来改善治疗效果,提高治疗功效,将健康组织中的细胞毒性降至最低,并最终降低化疗不良反应的强度。本研究基于随机临床试验的结果,前瞻性地评估了将抗肿瘤药物制成纳米药物对癌症患者的临床反应、总生存期、安全性和生活质量的影响。 方法:通过系统检索PubMed/医学文献分析与联机检索系统(MEDLINE)、医学文摘数据库(EMBASE)以及拉丁美洲和加勒比健康科学文献数据库(LILACS),对III期临床试验进行文献综述,比较纳米药物与传统疗法治疗各种癌症类型的效果。 结果:考虑到巴西先进癌症治疗的新兴市场,分析的纳米药物是那些在巴西已获批使用的药物。在总共找到的303篇文章中,选择了26篇进行系统综述。研究表明,聚乙二醇化L-天冬酰胺酶与L-天冬酰胺酶具有相似的治疗效果,由于其半衰期较长,应用次数较少。白蛋白结合型紫杉醇提高了治疗效果,并缩短了输注时间,降低了传统紫杉醇制剂与溶剂相关的毒性。与游离阿霉素相比,聚乙二醇化脂质体阿霉素显示出更好的药代动力学,降低了心脏毒性,并改善了癌症患者的生活质量。 结论:本研究强化了纳米药物在提高化疗患者治疗效果和降低毒性方面具有附加价值的科学证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57d/12277848/2dbe294bd595/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57d/12277848/28bc6c53970b/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57d/12277848/cc0d0236a00c/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57d/12277848/2dbe294bd595/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57d/12277848/28bc6c53970b/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57d/12277848/cc0d0236a00c/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57d/12277848/2dbe294bd595/gr2.jpg

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[1]
An overview of randomized phase III clinical trials of cancer nanomedicines.

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[2]
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[7]
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[10]
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本文引用的文献

[1]
Advanced bioanalytical techniques for pharmacokinetic studies of nanocarrier drug delivery systems.

J Pharm Anal. 2025-1

[2]
Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives.

Acta Biomater. 2024-5

[3]
Current status and prospects for improved targeted delivery approaches for cancer.

Pathol Res Pract. 2024-1

[4]
Pegylated liposomal doxorubicin (PLD) in daily practice-A single center experience of treatment with PLD in patients with comorbidities and older patients with metastatic breast cancer.

Cancer Med. 2023-6

[5]
HDACIs and TKIs combinations and their liposomal delivery for cancer treatment.

J Control Release. 2023-6

[6]
Hydrocortisone in Severe Community-Acquired Pneumonia.

N Engl J Med. 2023-5-25

[7]
Cancer nanomedicine: a review of nano-therapeutics and challenges ahead.

RSC Adv. 2023-3-14

[8]
Nanoparticle-based drug delivery systems for cancer therapy.

Smart Mater Med. 2020

[9]
(Poly-cyanoacrylate) nanomedicines for cancer and beyond: Lessons learned.

J Control Release. 2021-6-10

[10]
Cancer Statistics, 2021.

CA Cancer J Clin. 2021-1

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