New Drug for the Treatment of Inoperable Pancreatic Cancer?
In Germany, pancreatic cancer is the malignancy with the lowest survival rates. Even though anti-tumor therapy with cytostatic and targeted agents helps to alleviate symptoms and improves the median time of survival to 7–11 months, there is still a significant unmet need for new and effective drugs (1).
Deutsches Ärzteblatt published the results of a quality-of-life analysis from a randomized clinical study investigating the use of a mistletoe product (Viscum album [L.]) in patients with inoperable pancreatic carcinoma. This single-center study was conducted in Belgrade (Serbia). In the mistletoe arm, median survival was significantly longer compared with the control arm (4.8 months versus 2.7 months) (2).
Unfortunately, this study had several methodological shortcomings. Of these, the most significant are as follows:
- Only 43 of the 220 patients had the diagnosis pancreatic carcinoma confirmed by histology. In 25 patients, the diagnosis was solely based on imaging findings.
- The study had no placebo control. Lack of blinding at randomization has a particularly strong influence in studies with subjective endpoints such as quality of life (3).
- The study conditions are not transferable to the setting in Germany. The patients in the control arm received no anti-tumor therapy. No interdisciplinary tumor board was involved.
- The study arms show significant imbalances with regard to the number of analyzable patients.
Apart from methodological aspects, the publication in the DÄ has a health political dimension. For some years now, scientific societies and the German Cancer Aid, among others, have undertaken significant efforts to integrate complementary and alternative treatment modalities into cancer patients’ care (3). The publication of biased studies which are not transferable to the setting of care in Germany, sends out a signal in the wrong direction.
Prof. Dr. med. Bernhard Wörmann
Deutsche Gesellschaft für Hämatologie
und Medizinische Onkologie
Conflict of interest statement
The author declares that no conflict of interest exists.
|1.||Oettle H et al.: Pankreaskarzinom. Leitlinien von DGHO, OeGHO, SGMO und SGH+SSH, Status September 2014. www.dgho-onkopedia.de/de/onkopedia/leitlinien/pankreaskarzinom (last accessed on 8 December 2014).|
|2.||Tröger W, Galun D, Reif M et al.: Viscum album (L.) extract therapy in patients with locally advanced or metastatic pancreatic cancer: a randomized clinical trial on overall survival. Eur J Cancer 2013; 18: 3788–97. CrossRef MEDLINE|
|3.||Wörmann B et al.: Nutzenbewertung von Arzneimitteln der Onkologie und Hämatologie Kapitel 22.214.171.124, 2013. www.dgho.de/informationen/gesundheitspolitische-schriftenreihe/dgho_gpsr_arzneimittelnutzenbewertung.pdf (last accessed on on 8 December 2014).|
|4.||Tröger W, Galun D, Reif M, Schumann A, Stankovic´ N, Milic´ evic´ : M: Quality of life of patients with advanced pancreatic cancer during treatment with mistletoe—a randomized controlled trial. Dtsch Arztebl Int 2014; 111: 493–502. VOLLTEXT|