August 02, 2013
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Viscum album therapy safe, effective in pancreatic cancer

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Second-line therapy with Viscum album extract significantly extended OS among patients with locally advanced or metastatic pancreatic cancer, according to the results of a prospective phase 3 study.

Findings from the single-center, open-label trial also showed Viscum album to be nontoxic and effective at reducing disease-related symptoms.

Researchers assessed data from 220 patients with pancreatic cancer who were stratified with regard to tumor stage, age and performance status. The investigators randomly assigned patients to Viscum album treatment or no antineoplastic therapy.

Patients assigned to the treatment arm received subcutaneous injections of Viscum album three times a week. Doses incrementally increased from 0.01 mg to 10 mg.

Patients in both arms received supportive care.

Twelve-month OS served as the primary endpoint.

Results of an interim analysis demonstrated patients assigned to Viscum album treatment experienced longer OS (4.8 months vs. 2.7 months; prognosis-adjusted HR=0.49; P<.0001).

Within a subgroup of patients characterized as having good prognosis, researchers reported median OS of 6.6 months among those in the treatment arm vs. 3.2 months among those in the control arm (HR=0.43; P<.0001). In a subgroup of patients characterized as having poor prognosis, median OS was 3.4 months among those in the treatment arm vs. 2 months for those in the control arm (HR=0.55; P=.0031).

Researchers observed no treatment-related adverse events.