PDF(Pubmed)
Abstract：
Cancer progression and mortality remain challenging because of current obstacles and limitations in cancer treatment. Continuous efforts are being made to explore complementary and alternative approaches to alleviate the suffering of cancer patients. Epidemiological and nutritional studies have indicated that consuming botanical foods is linked to a lower risk of cancer incidence and/or improved cancer prognosis after diagnosis. From these observations, a variety of preclinical and clinical studies have been carried out to evaluate the potential of botanical food products as anticancer medicines. Unfortunately, many investigations have been poorly designed, and encouraging preclinical results have not been translated into clinical success. Botanical products contain a wide variety of chemicals, making them more difficult to study than traditional drugs. In this review, with the consideration of the regulatory framework of the USFDA, we share our collective experiences and lessons learned from 20 years of defining anticancer foods, focusing on the critical aspects of preclinical studies that are required for an IND application, as well as the checkpoints needed for early-phase clinical trials. We recommend a developmental pipeline that is based on mechanisms and clinical considerations.
摘要：
由于目前癌症治疗中的障碍和限制,癌症进展和死亡率仍然具有挑战性。正在不断努力探索减轻癌症患者痛苦的补充和替代方法。流行病学和营养学研究表明，食用植物性食物与诊断后降低癌症发病率和/或改善癌症预后有关。从这些观察来看,已经进行了各种临床前和临床研究，以评估植物食品作为抗癌药物的潜力。不幸的是,许多调查设计不当，令人鼓舞的临床前结果尚未转化为临床成功。植物产品含有各种各样的化学物质，使它们比传统药物更难以研究。在这次审查中,考虑到美国FDA的监管框架，我们分享我们从20年来定义抗癌食物的集体经验和教训，专注于IND应用所需的临床前研究的关键方面，以及早期临床试验所需的检查点。我们推荐一个基于机制和临床考虑的发展管道。
