712P - Mistletoe extract therapy versus no antineoplastic therapy in patients with locally advanced or metastatic pancreatic cancer: a randomized clinical...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Supportive Care
Pancreatic Cancer
Presenter Danijel Galun
Authors D. Galun1, W. Tröger2, M. Reif3, A. Schumann4, N. Stanković5, M. Milićević1
  • 1Hpb Surgical Department, First Surgical Clinic of the Clinical Centre of Serbia, 11000 - Belgrade/YU
  • 2Directorship, CRDT, Freiburg/DE
  • 3Institute for Clinical Research, 10623 - Berlin/DE
  • 4Biometry, Institute for Clinical Research, Berlin/DE
  • 5Data Management, CLINICOBSS, Niš/YU

Abstract

Purpose

To compare the overall survival (OS) and quality of life (QoL) of advanced pancreatic cancer patients receiving mistletoe extract (ME) therapy or no antineoplastic therapy.

Patients and methods

In this prospective, parallel, open label, monocenter, group-sequential, randomized phase III study patients with locally advanced or metastatic adenocarcinoma of the pancreas were stratified according to their prognosis index, a binary composite of age, tumor stage and performance status, and were evenly randomized to s.c. injections of ME (Iscador® Qu special) in a dose-escalating manner from 0.01 mg up to 10 mg three times per week, or no antineoplastic therapy (control). All patients received best supportive care. The primary endpoint was 12-month OS to be repeatedly assessed in three subsequent group-sequential analyses. Secondary efficacy parameters were the QoL dimensions of the core questionnaire of the European Organisation for Research and Treatment of Cancer.

Results

This first interim analysis includes data from 220 patients. Baseline characteristics were well balanced between the ME and control groups. Median OS for ME versus control patients was 4.8 vs. 2.7 months (prognosis-group adjusted hazard ratio, HR = 0.49; p < 0.0001); within the ‘good’ prognosis subgroup 6.6 vs. 3.2 months (HR = 0.43; p < 0.0001); within the ‘poor’ prognosis subgroup 3.4 vs. 2.0 months (HR = 0.55; p = 0.0031). Thirteen of the 15 QoL dimensions significantly favored ME. The ‘Global Health Status/QoL’ was sig-nificantly higher for ME versus control patients by 23.5 points (average patients' post-baseline median: 54.2 ± 8.17 vs. 30.7 ± 8.46; p < 0.0001). No ME-related serious or non-serious adverse events were observed.

Conclusion

In this analysis ME therapy showed a significant and clinically relevant increase of OS and quality of life. The independent data monitoring committee recommended the termination of the trial due to proven efficacy. ME may provide an effective second-line therapy for patients with locally advanced or metastatic pancreatic cancer after failure of, or ineligibility for, first-line therapies.

Disclosure

D. Galun: Danijel Galun has received financial compensation for the conduct of the submitted study by the Society of Cancer Research, Arlesheim. Otherwise, no payments were received.

W. Tröger: Wilfried Tröger has received financial compensation for the conduct of the submitted study and another clinical trial in breast cancer by the Society of Cancer Research, Arlesheim. Otherwise, no payments were received.

M. Reif: The non-profit organization Society for Clinical Research receives donations from different institutions including the sponsor of the submitted study, the Society of Cancer Research, Arlesheim.

A. Schumann: The non-profit organization Society for Clinical Research receives donations from different institutions including the sponsor of the submitted study, the Society of Cancer Research, Arlesheim.

N. Stanković: Nikola Stanković has received financial compensation for the conduct of the submitted study by the Society of Cancer Research, Arlesheim. Otherwise, no payments were received.

M. Milićević: Miroslav Milićević has received financial compensation for the conduct of the submitted study by the Society of Cancer Research, Arlesheim. Otherwise, no payments were received.