Huber Roman, Schlodder Dietrich, Effertz Carola, Rieger Sabine, Tröger Wilfried
Center for Complementary Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Breisacher Str. 115B, 79106, Freiburg im Breisgau, Germany.
Helixor Heilmittel GmbH, Rosenfeld, Germany.
BMC Complement Altern Med. 2017 Sep 18;17(1):465. doi: 10.1186/s12906-017-1971-1.
Mistletoe extracts have anti-tumor properties and are approved for subcutaneous use in cancer patients. Data on Intravenous application are limited.
An aqueous extract from pine-mistletoe was used to investigate maximum tolerable dose (MTD) and safety of intravenous application. It was infused once weekly for 3 weeks in patients with advanced cancer. Any type of cancer was included; relevant exclusion criteria were concurrent chemo- or radiation therapy. The classical phase I 3 + 3 dose escalation scheme was followed. Predefined dose groups were 200, 400, 700, 1200 and 2000 mg. Maximum planned dose was 2000 mg. With the MTD three more patients should be treated for 9 weeks in order to evaluate intermediate term tolerability. Weekly during the treatment and 1 week later tolerability, clinical status, safety laboratory parameters and adverse events were documented.
Twenty-one patients (3 in the dose groups 200, 400, 700 and 1200 mg, respectively, 9 in the dose group 2000 mg) were included. MTD was not reached. Because one dose-limiting toxicity (DLT), an allergic reaction, occurred during infusion of 2000 mg, three more patients had to be included in this dose group and tolerated it, as well as the three patients who received 2000 mg for 9 weeks. Occasionally in the dose group 2000 mg mild to moderate fever occurred.
Weekly infusions of 2000 mg of the pine-mistletoe extract were tolerated and can be used in further studies but had a risk for allergic reactions and fever. German Clinical Trials Register (Trial registration number DRKS00005028).
槲寄生提取物具有抗肿瘤特性，已被批准用于癌症患者的皮下注射。关于静脉注射应用的数据有限。
使用松槲寄生的水提取物来研究静脉注射的最大耐受剂量（MTD）和安全性。对晚期癌症患者每周输注一次，共3周。纳入任何类型的癌症；相关排除标准为同时进行化疗或放疗。遵循经典的I期3+3剂量递增方案。预定义的剂量组为200、400、700、1200和2000毫克。最大计划剂量为2000毫克。确定MTD后，应再治疗3名患者9周，以评估中期耐受性。在治疗期间每周以及治疗1周后记录耐受性、临床状态、安全实验室参数和不良事件。
纳入21名患者（剂量组200、400、700和1200毫克各3名，剂量组2000毫克9名）。未达到MTD。由于在输注2000毫克时发生了1例剂量限制性毒性（DLT），即过敏反应，该剂量组不得不额外纳入3名患者，他们以及接受2000毫克治疗9周的3名患者均耐受该剂量。在剂量组2000毫克中偶尔会出现轻度至中度发热。
每周输注2000毫克松槲寄生提取物是可耐受的，可用于进一步研究，但有过敏反应和发热的风险。德国临床试验注册中心（试验注册号DRKS00005028）。
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