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

BMC Complementary and Alternative Medicine

Research Article

Anja Thronicke¹  Friedemann Schad²  Christian Grah²  Megan L. Steele³  Burkhard Matthes⁴ 

[1] Forschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany;Forschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany;Gemeinschaftskrankenhaus Havelhöhe, Kladower Damm 221, 14089, Berlin, Germany;Forschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany;Institute of Health and Biomedical Innovation, School of Public Health and Social Work, Queensland University of Technology, Park Road, 4059, Brisbane, VIC, Australia;Forschungsinstitut Havelhöhe gGmbH, Kladower Damm 221, 14089, Berlin, Germany;Klinikum Brandenburg der Medizinischen Hochschule Brandenburg, Hochstr 29, 14770, Brandenburg, Germany;

关键词: Targeted therapy;    Immune checkpoint inhibitors;    PD-1;    CTLA-4;    Mistletoe;    Viscum album;    Drug interaction;   

DOI  :  10.1186/s12906-017-2045-0

 received in 2017-02-23, accepted in 2017-12-05,  发布年份 2017

来源: Springer

【 摘 要 】

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).

【 授权许可】

CC BY   
© The Author(s). 2017