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- Title
A Confirmatory Randomized Controlled Trial With Mistletoe Extract On Overall Survival In Patients With Locally Advanced Or Metastatic Pancreatic Cancer.
- Authors
Baumgartner, Stephan; Galun, Danijel; Reif, Marcus; Tr¶ger, Wilfried
- Abstract
Background Current second line treatments for late-stage pancreatic cancer patients are often so toxic that their risk-benefit ratios are unfavourable. Therefore, effective but non-toxic therapeutic approaches should be examined. Mistletoe extract (ME) therapy claims to be both, effective and non-toxic. The aim of this study was to assess the efficacy of ME regarding the overall survival (OS), quality of life (QoL), and safety in patients with locally advanced or metastatic adenocarcinoma of the pancreas. Methods In this randomized study (ISRCTN70760582) patients were stratified according to a binary prognosis index and evenly randomized to receive s.c. injections of ME (Iscador® Qu) in a dose-escalating manner from 0.01 mg up to 10 mg three times per week, or no antineo-plastic therapy (control). All patients received best supportive care. The primary endpoint was 12-month OS. Results Baseline characteristics were well balanced between the ME and control group. Median OS for ME versus control patients was 4.8 vs. 2.7 months (prognosis-group adjusted hazard ratio, HR=0.49; p.
- Subjects
PANCREATIC cancer; RANDOMIZED controlled trials; METASTASIS; MISTLETOES
- Publication
Journal of Cancer Research & Therapeutics, 2017, Vol 13, pS51
- ISSN
0973-1482
- Publication type
Article