P-013 Experience with the standardized fermented mistletoe extract (Viscum album L.) Iscador® as a part of long-term supportive care in patients with primary non-metastatic colorectal carcinoma E. Friedel1, H. Matthes2, P.R. Bock3 1Hospital Bad Bocklet, Department of Internal Medicine and Oncology, Bad Bocklet, Germany 2Hospital Havelhöhe, Oncology Clinic, Berlin, Germany 3Institute for Applied Medical Research, IFAG Basel AG, Basel, Switzerland Mistletoe therapy is a frequently used supportive treatment in cancer patients in Germany and Switzerland, mainly to reduce adverse drug reactions of adjuvant therapy (ADRs) and improve quality of life. Objectives: To evaluate efficacy and safety of mistletoe extract Iscador® (ISC) in supportive care of surgically treated patients with primary non-metastatic colorectal carcinoma in comparison with a parallel control group (control) without ISC from the same cohort Methods: In a multicenter, epidemiological, observational cohort study in Germany and Switzerland, ISC was given in addition to conventional adjuvant chemo- and radiotherapy (conventional therapy), and the control was treated with conventional therapy only. Unselected, chronologically ordered, standardized anonymous data from medical records that satisfied the pre-specified eligibility criteria were followed up until the last visit or death. The endpoints were ADRs by the conventional therapy, disease and treatment-associated symptoms, performance, hospitalization and survival. Safety was assessed by the number of patients with ISC-related ADRs. All endpoints were adjusted to baseline imbalance, therapy regimen and other confounders. Results: In 804 (429 ISC and 375 control) evaluable patients from 26 centers, the majority of the baseline characteristics, prognostic criteria, and main therapeutic measures was sufficiently balanced between the therapy groups. After a median follow up of 61 vs. 56 months, and a median ISC therapy duration of 53 months, significantly fewer ISC (19.1%) than control patients (48.3%) developed ADRs by the conventional therapy (p<0.001), had fewer persistent, mainly gastrointestinal and CNS, symptoms during the therapy (p≤0.001), and had on average one week shorter hospitalization (p=0.004). ISC vs. control patients showed a longer tumor-free survival with an estimated 28% hazard ratio reduction (p=0.026). In the ISC group 2,3% of the patients developed treatment systemic reactions and 23,3% had local reactions at the injection site. Severe ISC-related ADRs or tumor enhancement were not observed. Conclusions: In comparison to the parallel control group, the ISC-group showed significantly fewer ADRs of the conventional therapy, fewer disease- and therapy-related symptoms, and longer tumor-free survival. The ISC treatment was well tolerated and appears beneficial in the supportive care in patients with primary non-metastatic colorectal carcinoma. MASCC, 2007 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.