An overview of randomized phase III clinical trials of cancer nanomedicines

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.

Keywords: Antineoplastic drugs; Chemotherapy; Clinical trials; Drug delivery systems; Nanomedicine; Personalized medicine.

Graphical abstract

Figure 1

Flowchart of bibliographical research, detailing the identification, screening, and eligibility and selection of articles published between January 1990 and July 2024.

Figure 2

Recorded main outcomes of cancer nanomedicines described in the articles selected and discussed in Table 2, highlighting the percentage of improvements reported for the three types of nanomedicines regarding effectiveness, reduced toxicity, overall survival, efficacy in combination with other drugs, and patients' compliance.