An overview of randomized phase III clinical trials of cancer nanomedicines

Cancer pathogenesis and therapy Pub Date : 2025-07-01 DOI:10.1016/j.cpt.2024.10.001

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

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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.

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肿瘤纳米药物随机III期临床试验综述

近几十年来，由于个性化医疗和靶向给药，癌症治疗取得了重大进展。在这些有前景的方法中，使用纳米为基础的递送系统已经成为一种相关的方法，能够通过在靶点释放抗肿瘤药物来改善治疗，提高治疗效果，最小化健康组织中的细胞毒性，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，前瞻性地评估了抗肿瘤药物作为纳米药物对癌症患者临床反应、总体生存期、安全性和生活质量的影响。方法系统检索PubMed/MEDical literature Analysis and Retrieval System Online （MEDLINE）、abstracts Medica Database （EMBASE）和Latin American and Caribbean Health Sciences literature （LILACS）数据库进行III期临床试验的文献综述，比较纳米药物与常规疗法治疗不同类型癌症的疗效。考虑到巴西是一个新兴的晚期癌症治疗市场，所分析的纳米药物是那些在巴西获得批准和使用的药物。从共发现的303篇文献中，选择26篇进行系统评价。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，但由于其半衰期较长，应用较少。与传统紫杉醇制剂相比，紫杉醇与白蛋白结合提高了治疗效果，减少了输注时间和溶剂相关毒性。与游离阿霉素相比，聚乙二醇化脂质体阿霉素在癌症患者中表现出更好的药代动力学，降低心脏毒性，改善生活质量。结论本研究为纳米药物在化疗患者中提高疗效、降低毒副作用的附加价值提供了科学依据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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