Improved supportive care in pancreatic carcinoma UICC stages I–IV patients using fermented mistletoe (Viscum album L.) extract

Abstract

Background The fermented mistletoe extract Iscador ® (ISC) is applied in supportive care of surgically treated pancreatic carcinoma patients to reduce adverse drug reactions (ADR) induced by conventional therapy (ConTh) and to improve quality of life (QoL). Methods In a multicenter comparative non-interventional cohort study, efficacy and safety of ISC given additionally to ConTh (gemcitabine and/or 5-fluorouracil and/or radiotherapy) were investigated and compared to a parallel control group without ISC. Unselected standardized anonymized data from medical records of patients meeting the eligibility criteria were followed-up until last visit or death. As statistical endpoints ADR related to ConTher, disease- and treatment-associated symptoms, duration of hospitalization, and overall survival (OS) were evaluated. All endpoints were adjusted to confounders. Results From 17 centers we could evaluate a total of 396 (201 ISC and 195 control) surgically treated patients. Follow-up was (median) 15.2 vs. 10.1 months, and ISC therapy duration (median) 15.0 months. Significantly fewer ISC (13.7%) than control patients (48.9%) developed ADR by ConTh ( p p p =0.001), with a 42% relative hazard reduction. No severe ISC-related ADRs or tumor enhancement were observed. Conclusion The ISC-treated group showed significantly fewer ConTh-induced ADRs, fewer disease- and therapy-related symptoms, shorter hospitalization, and a longer OS. The ISC-treatment was well tolerated and appears beneficial in supportive care in patients with all stages of pancreatic carcinoma.