PMID- 30200590
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2305-6320 (Print)
IS  - 2305-6320 (Electronic)
IS  - 2305-6320 (Linking)
VI  - 5
IP  - 3
DP  - 2018 Sep 6
TI  - Clinical Safety of Combined Targeted and Viscum album L. Therapy in Oncological 
      Patients.
LID - 10.3390/medicines5030100 [doi]
LID - 100
AB  - 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 (chi(2) = 4.1, p = 
      0.04) and to discontinuation of standard oncological treatment (chi(2) = 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.
FAU - Thronicke, Anja
AU  - Thronicke A
AD  - Network Oncology, Research Institute Havelhohe, Kladower Damm 221, 14089 Berlin, 
      Germany. anja.thronicke@havelhoehe.de.
FAU - Oei, Shiao Li
AU  - Oei SL
AD  - Network Oncology, Research Institute Havelhohe, Kladower Damm 221, 14089 Berlin, 
      Germany. shiaoli.oei@havelhoehe.de.
FAU - Merkle, Antje
AU  - Merkle A
AD  - Network Oncology, Research Institute Havelhohe, Kladower Damm 221, 14089 Berlin, 
      Germany. antje.merkle@havelhoehe.de.
AD  - Oncological Centre, Hospital Havelhoehe, Kladower Damm 221, 14089 Berlin, 
      Germany. antje.merkle@havelhoehe.de.
FAU - Matthes, Harald
AU  - Matthes H
AD  - Network Oncology, Research Institute Havelhohe, Kladower Damm 221, 14089 Berlin, 
      Germany. harald.matthes@havelhoehe.de.
AD  - Medical Clinic for Gastroenterology, Infectiology and Rheumatology CBF and 
      Institute of Social Medicine, Epidemiology and Health Economics CCM, Charite 
      University Hospital Berlin, 10117 Berlin, Germany. harald.matthes@havelhoehe.de.
FAU - Schad, Friedemann
AU  - Schad F
AUID- ORCID: 0000-0002-6928-6209
AD  - Network Oncology, Research Institute Havelhohe, Kladower Damm 221, 14089 Berlin, 
      Germany. fschad@havelhoehe.de.
AD  - Oncological Centre, Hospital Havelhoehe, Kladower Damm 221, 14089 Berlin, 
      Germany. fschad@havelhoehe.de.
LA  - eng
GR  - n.a./Helixor Heilmittel/
GR  - n.a./Abnoba GmbH/
GR  - n.a./Iscador AG/
PT  - Journal Article
DEP - 20180906
PL  - Switzerland
TA  - Medicines (Basel)
JT  - Medicines (Basel, Switzerland)
JID - 101671069
PMC - PMC6164814
OTO - NOTNLM
OT  - Viscum album L.
OT  - combinational therapy
OT  - immune checkpoint inhibitors
OT  - monoclonal antibody therapy
OT  - safety analysis
OT  - targeted therapy
OT  - toxicity profile
OT  - treatment discontinuation
COIS- F.S. reports grants from Helixor Heilmittel GmbH, Iscador AG and ABNOBA GmbH 
      outside the submitted work. All other authors declare that they have no competing 
      interests.
EDAT- 2018/09/12 06:00
MHDA- 2018/09/12 06:01
PMCR- 2018/09/06
CRDT- 2018/09/12 06:00
PHST- 2018/08/20 00:00 [received]
PHST- 2018/09/03 00:00 [revised]
PHST- 2018/09/04 00:00 [accepted]
PHST- 2018/09/12 06:00 [entrez]
PHST- 2018/09/12 06:00 [pubmed]
PHST- 2018/09/12 06:01 [medline]
PHST- 2018/09/06 00:00 [pmc-release]
AID - medicines5030100 [pii]
AID - medicines-05-00100 [pii]
AID - 10.3390/medicines5030100 [doi]
PST - epublish
SO  - Medicines (Basel). 2018 Sep 6;5(3):100. doi: 10.3390/medicines5030100.