论文标题：Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial

期刊：Nature Communications

作者：Stefanie de Groot, Rieneke T. Lugtenberg et.al

发表时间：2020/06/23

数字识别码：10.1038/s41467-020-16138-3

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根据《自然-通讯》发表的一项文章Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial随机对照2期临床试验，“模拟禁食”（fasting mimicking）饮食或能增强初期化疗对乳腺癌患者的效果。模拟禁食饮食是一种低卡路里、低蛋白的饮食，设计目的是为了产生与只喝水禁食法所类似的代谢反应。

临床前证据显示，短期内的禁食以及模拟禁食饮食可以保护化疗中的健康细胞，同时让癌细胞更易受到化疗的攻击。不过，评估癌症患者短期禁食潜在作用的临床研究仍处于起始阶段。

在荷兰莱顿大学医学中心的Judith Kroep和同事开展的临床试验中，129名HER2阴性II期或III期乳腺癌患者在新辅助化疗（用于在术前缩小肿瘤的初步治疗）前三天和化疗期间分别采取模拟禁食饮食或常规饮食。试验中的模拟禁食饮食是一种植物性、低氨基酸的替代饮食，由汤、羹、液体和茶组成。虽然治疗组和对照组之间并未观察到毒性差异，但在模拟禁食饮食组中，新辅助化疗对患者肿瘤反应的作用增强了。对（无复发）生存率的随访仍在进行中。

患者入组流程图

credit: Kroep et al.

该研究结果表明，对于早期乳腺癌女性患者来说，周期性模拟禁食饮食可作为化疗过程中安全且有效的补充。以上研究结果以及临床前数据鼓励研究人员进一步探索禁食与癌症治疗相结合的好处。

摘要：Short-term fasting protects tumor-bearing mice against the toxic effects of chemotherapy while enhancing therapeutic efficacy. We randomized 131 patients with HER2-negative stage II/III breast cancer, without diabetes and a BMI over 18 kg m−2, to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy. Here we show that there was no difference in toxicity between both groups, despite the fact that dexamethasone was omitted in the FMD group. A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039). Moreover, per-protocol analysis reveals that the Miller&Payne 4/5 pathological response, indicating 90–100% tumor-cell loss, is more likely to occur in patients using the FMD (OR 4.109, P = 0.016). Also, the FMD significantly curtails chemotherapy-induced DNA damage in T-lymphocytes. These positive findings encourage further exploration of the benefits of fasting/FMD in cancer therapy. Trial number: NCT02126449.

（来源：科学网）