Long-term supportive treatment with fermented mistletoe (viscum album L.) extract in primary nonmetastatic colorectal cancer: Best time to start with for optimal effectiveness

Abstract

e15099 Background: Safety and efficacy of fermented mistletoe extract (Iscador, ISC) in supportive care of post-surgical patients with primary colorectal cancer as compared to a parallel control group without ISC. Question: Is supportive ISC most effective when started before, during, or after radio- and/or chemotherapy? Methods: In a comparative, multicenter, non-interventional cohort study with parallel groups ISC was applied additionally to conventional adjuvant chemo- and/or radiotherapy (conv-th). The control group was treated with conv-th only. Unselected, standardized, anonymized data from medical records (1993–2002) meeting the eligibility criteria were followed until last visit or death. The pre-specified endpoints were the incidence of adverse drug reactions (ADR) caused by conv-th, and disease-free survival (DFS) in relation to start of ISC therapy before, during or after conv-th. All endpoints were adjusted to confounders. Results: 804 eligible patients (429 ISC and 375 control) from 26 centers were evaluated. ISC started mostly during conv-th (72.9%), and sometimes before (9.0%) or after (18.1%) conv-th. ISC dose was escalated from 0.01mg to 20mg as s.c. injection, 2–3 times weekly. The median follow-up time was 58 (ISC) vs. 51 months and median ISC duration was 52 months. The adjusted relative ADR risk was significantly lower in the ISC groups as compared to control: odds ratio, OR (95% CI) = 0.46 (0.28–0.77), p=0.003. The best results were found in patients where ISC started in parallel to conv-th. Analysis of DFS in the ISC subgroups is presently ongoing. ISC was well tolerated in all subgroups. Conclusions: The results show reliable safety and clinically relevant beneficial effects of ISC treatment, at best if applied in parallel to conv-th. [Table: see text]