Abstract

BackgroundDue to the rapid development of nanotechnology and nanocomplex synthetic techniques, a large number of nanoparticle-based cancer medicines have been evaluated or applied in clinical trials for utility. However, the quality, efficiency and adverse events of these trials are sometimes controversial. Our systematic review aimed to better summary the current nanoparticle-related randomized controlled trials for cancer treatment, assess their quality and analyze the outcomes reported. MethodsA comprehensive search was performed in electronic database as follows: PubMed, Embase, the Cochrane Library and Web of Science, until February 2024. We then identified the randomized controlled trials (RCTs) that investigate the nanoparticle-based therapy versus placebo, ordinary chemotherapy, standard of care or different doses of nanoparticles in cancer patients. The information, primary outcomes and adverse events records of trials were extracted. Results31 RCTs were included, Inside, 22 studies used paclitaxel related nanoparticle in their RCTs, including 18 trials of nanoparticle albumin-bound (nab)-paclitaxel. A total of 10399 patients were enrolled for evaluation. Most of the included trials were ranked as excellent or good quality after assessed according to CONSORT checklist. The treatment efficiency reflected via progression-free survival (PFS), overall survival (OS), and pathological complete response (pCR) were not significantly superior to control arm. Lymphopenia, leucopenia and neutropenia were the most common complications in paclitaxel-related therapies. ConclusionsAccording to current trials, the advantages of nanoparticles-based therapy were not significant compared to ordinary chemotherapy schedule no matter in efficiency or safety for cancer treatment. The majority of nanomedicine currently in evaluation is chemotherapy medicine related, lacking of the attempts of other treatment strategy. Thus, it is urgent to broaden the therapy strategy applied in nanoparticle utility for cancer treatment exploration.

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