Evidence map›Paper›PMID 29237435›Full record

Observational studyBMC complementary and alternative medicine2017

Clinical safety of combined therapy of immune checkpoint inhibitors and Viscum album L. therapy in patients with advanced or metastatic cancer.

Anja Thronicke, Megan L Steele, Christian Grah, Burkhard Matthes, Friedemann Schad

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC complementary and alternative medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Systematic analysis of mistletoe prescriptions in clinical studies.Journal of cancer research and clinical oncology · 2023
    Pooled it
  2. Pooled it
  3. Mistletoe in Cancer Cell Biology: Recent Advances.Current issues in molecular biology · 2025
    Review
  4. Combined Immune Checkpoint Blockade and HelixorInternational journal of molecular sciences · 2025
    Article
  5. Immune Checkpoint Blockade Combined with AbnobaViscumPharmaceuticals (Basel, Switzerland) · 2024
    Article
  6. Article
  7. Review
  8. The Antioxidant Activity of Mistletoes (Plants (Basel, Switzerland) · 2023
    Review
  9. The Anti-Inflammatory Activity ofPlants (Basel, Switzerland) · 2023
    Review
  10. Safety of Combined Targeted and HelixorInternational journal of environmental research and public health · 2023
    Observational
  11. Real-world Evidence of the Herb-drug Interactions.Journal of food and drug analysis · 2022
    Review
  12. Review
  13. Review
  14. [Complementary medicine in uro-oncology].Der Urologe. Ausg. A · 2021
    Article
  15. Article
  16. Mistletoe and Immunomodulation: Insights and Implications for Anticancer Therapies.Evidence-based complementary and alternative medicine : eCAM · 2019
    Review
  17. Article
  18. Article
  19. Clinical Safety of Combined Targeted andMedicines (Basel, Switzerland) · 2018
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Anja ThronickeForschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany.
Megan L SteeleForschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany.
Christian GrahForschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany.
Burkhard MatthesForschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany.
Friedemann SchadForschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany. fschad@havelhoehe.de.
Forschungsinstitut Havelhöhe · DEGemeinschaftskrankenhaus Havelhöhe · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite improvement of tumour response rates in patients with progressive and metastatic cancer, immune checkpoint inhibitors (ICM) induce toxicities in cancer patients. Viscum album L. (VA, mistletoe) extracts are applied as add-on cancer therapy especially in German speaking countries and within integrative and anthroposophical concepts with the goal to improve quality of life. The primary objective of this pilot observational cohort study was to determine the rate of adverse events (AE) related to ICM therapy with and without VA in patients with advanced or metastatic cancer in a certified Cancer Center.

methodsICM or combined ICM/VA therapies were applied in patients with progressive or metastatic cancer. AE rates of both therapy groups were compared.

resultsA total of sixteen cancer patients were treated with ICM: nivolumab (75%), ipilimumab (19%) or pembrolizumab (6%). The median age of the study population was 64 years (IQR 57.8; 69.3); 44% were male. Of the sixteen patients receiving ICM, nine patients received additional VA (56%; ICM/VA group) and seven did not (44%; ICM group). No statistically significant differences were seen between groups with respect to AE-rates (67% ICM/VA versus 71% ICM). Adjusted multivariate regression analysis revealed that concomitant application of VA did not alter the AE rate in ICM treated patients. 85% of AEs were expected ICM reactions. No AEs of grade 3 or greater were documented for the total study cohort.

conclusionsThis is the first study evaluating the clinical safety profile of ICM in combination with VA in patients with advanced or metastatic cancer. The overall AE rate of the study cohort is comparable to AE rates of ICM treatment in the literature. Our data indicate a first impression that concomitant VA application may not alter ICM-induced AE rates. However, the nature of this study does not allow excluding possible immunological interactions between ICM and VA. Further prospective trials in larger study cohorts should focus on the assessment of safety aspects, clinical efficacy and health related quality of life in patients with combined ICM/VA therapy.

trial registrationDRKS00013335 , retrospectively registered (November 27th, 2017) at the German Clinical Trials Register ( www.drks.de ).

Indexed as

Viscum albumAgedAntineoplastic AgentsFemaleHerb-Drug InteractionsHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasmsPilot ProjectsPlant ExtractsProgrammed Cell Death 1 ReceptorAntineoplastic AgentsPlant ExtractsProgrammed Cell Death 1 ReceptorCTLA-4Drug interactionImmune checkpoint inhibitorsMistletoePD-1Targeted therapyViscum album L.

Identifiers

PMID29237435
PMCPMC5729272
OpenAlexW2774023743

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.