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Supportive therapy with mistletoe extract in tumor patients - Results of four controlled pharmacoepidemiological cohort studies as basis for prospective studies.

Aim of the studies: Efficacy and tolerance of mistletoe extracts

Iscador[R] (ISC) P, Qut and M (host trees pinus pine, quercus oak, malus apple tree) as a supportive therapy in patients with primary malignant melanoma (UICC II-III), breast (UICC I-III), colorectal (UICC I-III) or pancreatic cancer (UICC I-IV).

Methods: Four multicenter, controlled, retrolective, phar-macoepidemiological cohort studies according to GEP (good epidemiological practice) with a total of 3376 patients were performed. Supportive ISC treatment was applied in the test group (1719 patients) additionally to adjuvant or palliative conventional oncological therapy (convTh, i.e., chemo-, radio- or other therapy -mostly after tumor surgery), while control patients (1657 patients) received convTh only. Unselected standardized, anonymized data were taken from medical records of patients and documented until last visit or death. Main endpoints were adverse events (AE) of the convTh, tumor and therapy related symptoms as surrogate markers for quality of life (QoL), disease-free (DFS) or overall survival (05), and tolerance of ISC. All endpoints were statistically evaluated by means of descriptive and multivariable methods, with adjustment to differences at baseline, therapy regimens and other confounding factors.

Results: All ISC sorts (P, Qu, M) were effective: AE of convTh and tumor- and therapy related symptoms were significantly reduced in all tumor entities except melanoma (too few patients with convTh); disease-free (DFS in colorectal cancer) or overall survival (OS in breast and pancreatic cancer and melanoma) was significantly prolonged in the ISC groups.

The various host-tree specific ISC extracts showed different efficacy profiles: ISC-P was particularly effective in breast cancer and malignant melanoma, ISC-Qu in colorectal and pancreatic cancer. All ISC sorts were well tolerated with on average 2.1% systemic (mostly mild and transient) and 18.1% local AE (mostly redness or itching at the site of injection).

Conclusions: The studies yielded good tolerance and efficacy of supportive ISC therapy. All endpoints were statistically significant better in the ISC groups.

Two controlled prospective cohort studies to verify these promising retrospective data have been started in colorectal and pancreatic cancer in Germany, Austria and Switzerland.

Keywords: Mistletoe; Breast cancer; Colorectal cancer; Pancreatic cancer; Malignant melanoma; Cohort study; Survival time; Adverse events

10.1016/j.phy med.2011.09.030

doi: 10.1016/j.phymed.2011.09.030

M. Werner (a), P.R. Bock (b), J. Hanisch (b), G. Stauder (b), *

(a.) Hiscia, Association for Tumor Research, Arlesheim, Switzerland

(b.) IFAC Basel AG, Institute for Medicine and Statistics, Ruemlingen, Switzerland

* Corresponding author. Tel.: +41 62 28500 30. E-mail address: IFAGBasel[congruent to] (G. Stauder).

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Article Details
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Author:Werner, M.; Bock, P.R.; Hanisch, J.; Stauder, G.
Publication:Phytomedicine: International Journal of Phytotherapy & Phytopharmacology
Article Type:Clinical report
Geographic Code:4EXSI
Date:Oct 15, 2011
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