Viscum album [L.]-Extrakt (Iscador®) bei Patienten mit lokal fortgeschrittenem oder metastasiertem Pankreaskarzinom: eine randomisierte klinische Überlebenszeitstudie

Wilfried Tröger, D. Galun, Marcus Reif, A. Schumann, Nikola Stankovic, M. Milicevic
Article-ID: DMS-20258-DE

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Hintergrund: Die übliche Therapie des fortgeschrittenen Pankreaskarzinoms hat häufig starke Nebenwirkungen, so dass nach effektiven, aber nicht-toxischen therapeutischen Ansätzen gesucht werden sollte. Methoden: Dies ist eine prospektive, parallele, offene, monozentrische, gruppen-sequenzielle, randomisierte Phase-III-Studie. 220 Patienten mit lokal fortgeschrittenem oder metastasiertem Pankreaskarzinom wurden zu gleichen Teilen randomisiert zu einer Gruppe mit VaL-Therapie (Iscador® Qu) oder zu einer Gruppe ohne jede Krebstherapie zugewiesen. Iscador® wurde ansteigend von 0,01 mg bis 10 mg dosiert und dreimal pro Woche subkutan injiziert. Wir verglichen die Überlebenszeit (ÜZ) von Patienten, die VaL erhielten, mit der ÜZ von Patienten ohne jedwede Krebstherapie.

Ergebnisse: Demographie- und Baselinecharakteristika der Patienten waren ausgeglichen. Die mediane Überlebenszeit war 4,8 Monate für die VaL-Patienten und 2,7 Monate für die Kontrollpatienten (Prognose-bereinigter Risikoquotient, HR=0,49; p<0,0001). In der Untergruppe mit günstiger Prognose war die mediane ÜZ 6,6 vs. 3,2 Monate (HR=0,43; p<0,0001); in der mit ungünstiger Prognose war die mediane ÜZ 3,4 vs. 2,0 Monate (HR=0,55; p=0,0031). Es wurden keine VaL-bedingten Nebenwirkungen beobachtet.

Folgerungen: Die Therapie mit VaL ergab eine klinisch relevante und signifikante Verlängerung der ÜZ. Die Studienergebnisse legen nahe, dass VaL eine nichttoxische und effektive Zweitlinientherapie für Patienten mit lokal fortgeschrittenem oder metastasiertem Pankreaskarzinom ist, die die ÜZ verlängert und die krankheitsbedingten Symptome mindert.

Viscum album [L.] extract (Iscador®) therapy in patients with locally advanced or metastatic pancreatic cancer: a randomized clinical trial on overall survival

Background: The unfavourable side-effects of latestage pancreatic cancer treatments call for non-toxic and effective therapeutic approaches. Methods: This is a prospective, parallel, open label, monocentre, group-sequential, randomised phase III study. 220 patients with locally advanced or metastatic cancer of the pancreas were stratified according to a binary prognosis index, composed of tumour stage, age and performance status; and were evenly randomised to subcutaneous injections of VaL extracts or no antineoplastic therapy (control). VaL was applied in a doseescalating manner from 0.01 mg up to 10 mg three times per week. We compared the overall survival (OS) of patients receiving an extract of Viscum album [L.] (VaL) or no antineoplastic therapy.

Findings: Baseline characteristics were well balanced between the study arms. Median OS was 4.8 for VaL and 2.7 months for control patients (prognosis-adjusted hazard ratio, HR=0.49; p<0.0001). Within the ‘good’ prognosis subgroup, median OS was 6.6 versus 3.2months (HR=0.43; p<0.0001), within the ‘poor’ prognosis subgroup, it was 3.4 versus 2.0 months respectively (HR=0.55; p=0.0031). No VaL-related adverse events were observed.

Conclusion: VaL therapy showed a significant and clinically relevant prolongation of OS. The study findings suggest VaL to be a non-toxic and effective secondline therapy that offers a prolongation of OS as well as less disease-related symptoms for patients with locally advanced or metastatic pancreatic cancer.

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