Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Section of Surgical Research, Department of General, Visceral & Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 365, 69120, Heidelberg, Germany.
Invest New Drugs. 2020 Jun;38(3):776-784. doi: 10.1007/s10637-019-00826-z. Epub 2019 Jun 27.
Pancreatic ductal adenocarcinoma is a highly aggressive malignancy with short survival and limited therapeutic options. Broccoli sulforaphane is a promising new treatment due to the results of recent epidemiological, experimental and patient studies. Upon approval from the ethics committee and registration at ClinicalTrials.gov, 40 patients with palliative chemotherapy were placed into a placebo and treatment group in an unblinded fashion. Fifteen capsules with pulverized broccoli sprouts containing 90 mg/508 μmol sulforaphane and 180 mg/411 μmol glucoraphanin or methylcellulose were administered daily for up to 1 year. Twenty-nine patients were included in the treatment group and 11 patients were in the placebo group; these patients were followed for up to 1 year. The patient characteristics, overall survival and feasibility were assessed. Compared to those of the placebo group, the mean death rate was lower in the treatment group during the first 6 months after intake (day 30: 0%/18%, day 90: 0%/25%, and day 180: 25%/43%), and Kaplan-Meier analysis revealed a higher survival rate. There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year. We concluded from the Karnofsky index that the broccoli sprouts did not impact patient's self-care and overall abilities severely. The intake of 15 capsules daily was difficult for some patients, and the broccoli sprouts sometimes increased digestive problems, nausea and emesis. We did not obtain statistically significant results (p = 0.291 for the endpoint at day 180), but the knowledge about the feasibility is the basis for the development of new sulforaphane drugs.
胰腺导管腺癌是一种侵袭性很强的恶性肿瘤,患者生存期短,治疗选择有限。西兰花硫代葡萄糖苷由于最近的流行病学、实验和患者研究结果,成为一种很有前途的新治疗方法。在伦理委员会批准并在 ClinicalTrials.gov 注册后,40 名接受姑息化疗的患者以非盲法方式被分为安慰剂组和治疗组。每天服用 15 粒含有 90mg/508μmol 萝卜硫素和 180mg/411μmol 葡萄糖苷的西兰花芽粉胶囊,持续 1 年。29 名患者被纳入治疗组,11 名患者被纳入安慰剂组;这些患者随访时间长达 1 年。评估了患者特征、总生存期和可行性。与安慰剂组相比,治疗组在摄入后前 6 个月(第 30 天:0%/18%,第 90 天:0%/25%,第 180 天:25%/43%)的平均死亡率较低,Kaplan-Meier 分析显示生存率较高。1 年后的脱落率很高(治疗组为 72%,安慰剂组为 55%)。根据 Karnofsky 指数,我们得出的结论是,西兰花芽粉并未严重影响患者的自理能力和整体能力。有些患者每天服用 15 粒胶囊比较困难,而且西兰花芽粉有时会增加消化问题、恶心和呕吐。我们没有得到统计学上显著的结果(第 180 天的终点 p=0.291),但对可行性的了解是开发新的萝卜硫素药物的基础。