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Medicines 2018, 5(3), 100; https://doi.org/10.3390/medicines5030100

Clinical Safety of Combined Targeted and Viscum album L. Therapy in Oncological Patients

1
Network Oncology, Research Institute Havelhöhe, Kladower Damm 221, 14089 Berlin, Germany
2
Oncological Centre, Hospital Havelhoehe, Kladower Damm 221, 14089 Berlin, Germany
3
Medical Clinic for Gastroenterology, Infectiology and Rheumatology CBF and Institute of Social Medicine, Epidemiology and Health Economics CCM, Charité University Hospital Berlin, 10117 Berlin, Germany
*
Author to whom correspondence should be addressed.
Received: 20 August 2018 / Revised: 3 September 2018 / Accepted: 4 September 2018 / Published: 6 September 2018
(This article belongs to the Special Issue Safety of Complementary Medicines)
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Abstract

Background: Despite improvement of tumor response rates, targeted therapy may induce toxicities in cancer patients. Recent studies indicate amelioration of adverse events (AEs) by add-on mistletoe (Viscum album L., VA) in standard oncological treatment. The primary objective of this multicenter observational study was to determine the safety profile of targeted and add-on VA therapy compared to targeted therapy alone. Methods: Demographic and medical data were retrieved from the Network Oncology registry. Allocation to either control (targeted therapy) or combinational group (targeted/add-on VA) was performed. Safety-associated variables were evaluated by adjusted multivariable analyses. Results: The median age of the study population (n = 310) at first diagnosis was 59 years; 67.4% were female. In total, 126 patients (40.6%) were in the control and 184 patients (59.4%) in the combination group. Significant differences were observed between both groups with respect to overall AE frequency (χ2 = 4.1, p = 0.04) and to discontinuation of standard oncological treatment (χ2 = 4.8, p = 0.03) with lower rates in the combinational group (20.1%, 35% respectively) compared to control (30.2%, 60.5%, respectively). Addition of VA to targeted therapy significantly reduced the probability of oncological treatment discontinuation by 70% (Odds ratio (OR) 0.30, p = 0.02). Conclusions: Our results indicate a highly significant reduction of AE-induced treatment discontinuation in all-stage cancer patients when treated with VA in addition to targeted therapy. View Full-Text
Keywords: safety analysis; toxicity profile; combinational therapy; targeted therapy; monoclonal antibody therapy; immune checkpoint inhibitors; treatment discontinuation; Viscum album L. safety analysis; toxicity profile; combinational therapy; targeted therapy; monoclonal antibody therapy; immune checkpoint inhibitors; treatment discontinuation; Viscum album L.
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).
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Thronicke, A.; Oei, S.L.; Merkle, A.; Matthes, H.; Schad, F. Clinical Safety of Combined Targeted and Viscum album L. Therapy in Oncological Patients. Medicines 2018, 5, 100.

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