Ramos Eva, Egea Javier, López-Muñoz Francisco, Gil-Martín Emilio, Romero Alejandro
Department of Pharmacology and Toxicology, Faculty of Veterinary Medicine, Complutense University of Madrid, 28040 Madrid, Spain.
Molecular Neuroinflammation and Neuronal Plasticity Research Laboratory, Hospital Universitario Santa Cristina, Instituto de Investigación Sanitaria-Hospital Universitario de la Princesa, 28006 Madrid, Spain.
Pharmaceutics. 2023 May 30;15(6):1616. doi: 10.3390/pharmaceutics15061616.
The purpose of this systematic review is to provide an overview of the existing knowledge on the therapeutic potential of melatonin to counteract the undesirable effects of chemotherapy in breast cancer patients. To this aim, we summarized and critically reviewed preclinical- and clinical-related evidence according to the PRISMA guidelines. Additionally, we developed an extrapolation of melatonin doses in animal studies to the human equivalent doses (HEDs) for randomized clinical trials (RCTs) with breast cancer patients. For the revision, 341 primary records were screened, which were reduced to 8 selected RCTs that met the inclusion criteria. We assembled the evidence drawn from these studies by analyzing the remaining gaps and treatment efficacy and suggested future translational research and clinical trials. Overall, the selected RCTs allow us to conclude that melatonin combined with standard chemotherapy lines would derive, at least, a better quality of life for breast cancer patients. Moreover, regular doses of 20 mg/day seemed to increase partial response and 1-year survival rates. Accordingly, this systematic review leads us to draw attention to the need for more RCTs to provide a comprehensive view of the promising actions of melatonin in breast cancer and, given the safety profile of this molecule, adequate translational doses should be established in further RCTs.
本系统评价的目的是概述褪黑素在对抗乳腺癌患者化疗不良反应方面的治疗潜力的现有知识。为此，我们根据PRISMA指南总结并批判性地回顾了临床前和临床相关证据。此外，我们对动物研究中的褪黑素剂量进行了推算，得出了乳腺癌患者随机临床试验（RCT）的人类等效剂量（HED）。在修订过程中，我们筛选了341条原始记录，最终确定了8项符合纳入标准的RCT。通过分析其余的差距和治疗效果，我们汇总了这些研究得出的证据，并提出了未来的转化研究和临床试验建议。总体而言，所选的RCT使我们能够得出结论，褪黑素联合标准化疗方案至少能改善乳腺癌患者的生活质量。此外，每天20毫克的常规剂量似乎能提高部分缓解率和1年生存率。因此，本系统评价促使我们关注需要更多的RCT，以全面了解褪黑素在乳腺癌中的潜在作用，并且鉴于该分子的安全性，应在进一步的RCT中确定合适的转化剂量。
