Pelzer Florian, Tröger Wilfried, Nat Dr Rer
1 Society for Cancer Research, Hiscia Institute , Arlesheim, Switzerland .
2 Clinical Research Dr. Tröger (CRDT) , Freiburg, Germany .
J Altern Complement Med. 2018 Sep/Oct;24(9-10):954-961. doi: 10.1089/acm.2018.0159.
Evaluate the safety and clinical response of complementary treatment with European mistletoe extracts during chemotherapy.
Monocentric controlled trial with 95 patients randomized into three groups.
SETTINGS/LOCATION: National Cancer Research Center of Serbia.
Breast cancer patients (stage TNM) undergoing surgery and adjuvant chemotherapy with six cycles of cyclophosphamide, adriamycin, and 5-fluorouracil.
Two different European mistletoe extracts (Helixor A, Iscador M Spez) were injected three times per week during 18 weeks of chemotherapy in the mistletoe group. Five-year follow-up of routine visits was documented in case report forms.
Safety was assessed by measuring adverse events, body temperature during chemotherapy, and probability of relapse or metastasis in a 5-year follow-up. During chemotherapy, the neutrophil count and quality of life according to EORTC QLQ-C30 were assessed.
The two patient groups receiving different complementary mistletoe treatments were integrated into one mistletoe group for this safety analysis. Patients in the mistletoe group did not develop more fever symptoms than patients in the control group (two short-term events in each group). No significant differences in probability of relapse or metastasis were measured between the groups (p = 0.7637). The mistletoe group showed a trend toward less neutropenia (p = 0.178) and improved pain and appetite loss scores (p < 0.0001 and p = 0.047, respectively) while having positive, but not significant, impact on other EORTC QLQ-C30 scores.
Mistletoe extracts were safe in this clinical study. Neither did subcutaneous injections induce fever, nor did they influence the frequency of relapse and metastasis within 5 years. This result suggests that mistletoe extracts had no adverse interactions with the anticancer agents used in this study. Furthermore, certain side effects of chemotherapy decreased under this complementary treatment in breast cancer patients.
评估在化疗期间使用欧洲槲寄生提取物进行辅助治疗的安全性和临床反应。
一项单中心对照试验，95名患者随机分为三组。
塞尔维亚国家癌症研究中心。
接受手术及六个周期环磷酰胺、阿霉素和5-氟尿嘧啶辅助化疗的乳腺癌患者（TNM分期）。
在槲寄生组化疗的18周期间，每周注射三次两种不同的欧洲槲寄生提取物（Helixor A、Iscador M Spez）。在病例报告表中记录了为期五年的常规随访情况。
通过测量不良事件、化疗期间的体温以及五年随访中的复发或转移概率来评估安全性。在化疗期间，根据欧洲癌症研究与治疗组织（EORTC）QLQ-C30评估中性粒细胞计数和生活质量。
在进行安全性分析时，接受不同辅助槲寄生治疗的两组患者被合并为一个槲寄生组。槲寄生组患者出现发热症状的情况并不比对照组多（每组各有两例短期事件）。两组之间复发或转移概率的差异无统计学意义（p = 0.7637）。槲寄生组出现中性粒细胞减少的趋势较小（p = 0.178），疼痛和食欲减退评分有所改善（分别为p < 0.0001和p = 0.047），同时对其他EORTC QLQ-C30评分有积极但不显著的影响。
在本临床研究中，槲寄生提取物是安全的。皮下注射既未引起发热，也未影响五年内的复发和转移频率。这一结果表明，槲寄生提取物与本研究中使用的抗癌药物没有不良相互作用。此外，在这种辅助治疗下，乳腺癌患者化疗的某些副作用有所减轻。
