Hosseini Mina, Seyedpour Simin, Khodaei Behzad, Loghman Amir-Hossein, Seyedpour Nasrin, Yazdi Mohammad-Hossein, Rezaei Nima
Department of Pharmaceutical Biotechnology, School of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 141556451, Iran.
School of Medicine, Tehran University of Medical Sciences, Tehran P.O. Box 1417613151, Iran.
Vaccines (Basel). 2023 Jan 9;11(1):146. doi: 10.3390/vaccines11010146.
Triple-negative breast cancer (TNBC) is the subtype of breast cancer with the poorest outcomes, and is associated with a high risk of relapse and metastasis. The treatment choices for this malignancy have been confined to conventional chemotherapeutic agents, due to a lack of expression of the canonical molecular targets. Immunotherapy has been recently changing the treatment paradigm for many types of tumors, and the approach of evoking active immune responses in the milieu of breast tumors through cancer vaccines has been introduced as one of the most novel immunotherapeutic approaches. Accordingly, a number of vaccines for the treatment or prevention of recurrence have been developed and are currently being studied in TNBC patients, while none have yet received any approvals. To elucidate the efficacy and safety of these vaccines, we performed a systematic review of the available literature on the topic. After searching the PubMed, Scopus, Web of Science, Embase, Cochrane CENTRAL, and Google Scholar databases, a total of 5701 results were obtained, from which 42 clinical studies were eventually included based on the predefined criteria. The overall quality of the included studies was acceptable. However, due to a lack of reporting outcomes of survival or progression in some studies (which were presented as conference abstracts) as well as the heterogeneity of the reported outcomes and study designs, we were not able to carry out a meta-analysis. A total of 32 different vaccines have so far been evaluated in TNBC patients, with the majority belonging to the peptide-based vaccine type. The other vaccines were in the cell or nucleic acid (RNA/DNA)-based categories. Most vaccines proved to be safe with low-grade, local adverse events and could efficiently evoke cellular immune responses; however, most trials were not able to demonstrate significant improvements in clinical indices of efficacy. This is in part due to the limited number of randomized studies, as well as the limited TNBC population of each trial. However, due to the encouraging results of the currently published trials, we anticipate that this strategy could show its potential through larger, phase III randomized studies in the near future.
三阴性乳腺癌（TNBC）是预后最差的乳腺癌亚型，且与高复发和转移风险相关。由于缺乏典型分子靶点的表达，这种恶性肿瘤的治疗选择一直局限于传统化疗药物。免疫疗法最近正在改变许多类型肿瘤的治疗模式，通过癌症疫苗在乳腺肿瘤环境中引发主动免疫反应的方法已作为最新型的免疫治疗方法之一被引入。因此，已经开发了多种用于治疗或预防复发的疫苗，目前正在TNBC患者中进行研究，但尚未有任何一种获得批准。为了阐明这些疫苗的疗效和安全性，我们对该主题的现有文献进行了系统综述。在搜索PubMed、Scopus、Web of Science、Embase、Cochrane CENTRAL和谷歌学术数据库后，共获得5701条结果，最终根据预定义标准纳入了42项临床研究。纳入研究的总体质量是可以接受的。然而，由于一些研究（以会议摘要形式呈现）缺乏生存或进展报告结果，以及报告结果和研究设计的异质性，我们无法进行荟萃分析。到目前为止，共有32种不同的疫苗在TNBC患者中进行了评估，其中大多数属于基于肽的疫苗类型。其他疫苗属于基于细胞或核酸（RNA/DNA）的类别。大多数疫苗被证明是安全的，具有低度局部不良事件，并且能够有效引发细胞免疫反应；然而，大多数试验未能证明临床疗效指标有显著改善。这部分是由于随机研究数量有限，以及每个试验中TNBC人群有限。然而，由于目前已发表试验的令人鼓舞的结果，我们预计这种策略在不久的将来通过更大规模的III期随机研究可能会展现其潜力。
