Mistletoe plant extract in patients with nonmuscle invasive bladder cancer: Results of a phase Ib/IIa single group dose escalation study

Theodor Bilharz Research Institute

Bibliographic Information

Authors: Rose A.; El-Leithy T.; Dorp F.V.; Zakaria A.; Eisenhardt A.; Tschirdewahn S.; Rübben H.

Journal: Journal of Urology

Publisher: Elsevier Inc.

Publication Date: October 2015

Volume / Issue: Volume 194 / Issue 4

Pages: 939–943

ISSN: 225347

DOI: 10.1016/j.juro.2015.04.073

Scopus: View on Scopus

PubMed: 25910967

Document Type: Article

Authors and Affiliations

Rose A., Department of Urology, HELIOS Marien Klinik, Wanheimerstr. 167a, Duisburg, 47053, Germany; El-Leithy T., Theodor Bilharz Research Institute, Cairo, Egypt; Dorp F.V., Department of Urology, HELIOS Marien Klinik, Wanheimerstr. 167a, Duisburg, 47053, Germany; Zakaria A., Theodor Bilharz Research Institute, Cairo, Egypt; Eisenhardt A., Praxis Urologie Rhein/Ruhr, Mülheim an der Ruhr, Germany; Tschirdewahn S., Department of Urology, University Hospital of Essen, Essen, Germany; Rübben H., Department of Urology, University Hospital of Essen, Essen, Germany

Abstract

Purpose We determined the maximum tolerated dose, safety and effectiveness of intravesical instillation of mistletoe extract after transurethral resection of nonmuscle invasive bladder cancer. Materials and Methods In this single group dose escalation study patients with nonmuscle invasive bladder cancer were treated with weekly instillations of mistletoe extract for 6 weeks. Four weeks before instillation therapy all patients underwent transurethral resection of bladder tumors. During this procedure a marker tumor was left. At 12 weeks after the start of instillation therapy transurethral resection of the marker tumor or biopsy of the former marker tumor location was done so that patients were tumor free when entering followup until week 48. During the followup clinical assessment laboratory tests for safety and cystoscopy were done every 12 weeks. Results A total of 36 patients were treated with increasing doses of mistletoe extract. We found no dose limiting toxicity up to a dose of 675 mg of plant extract. Besides local reactions we saw hints that pyrexia may develop. All adverse events were well manageable. At 12 weeks a marker tumor remission rate of 55.6% (95% CI 38.1 to 72.1) was achieved. At 1 year a recurrence rate of 26.3% (95% CI 9.1 to 51.2) was observed. Conclusions In this study intravesical instillation of mistletoe extract as treatment in patients with nonmuscle invasive bladder cancer was shown to be safe and well tolerated. Promising data on efficacy were observed and will be further investigated in a phase III study. © 2015 American Urological Association Education and Research, Inc.

Keywords

abnoba viscum; administration; intravesical; mistletoe; treatment outcome; urinary bladder neoplasms; Administration, Intravesical; Female; Humans; Male; Middle Aged; Neoplasm Invasiveness; Phytotherapy; Plant Extracts; hemoglobin variant; Viscum album extract; plant extract; adult; Article; bladder biopsy; clinical article; clinical assessment; controlled study; cystoscopy; drug dose escalation; drug dose increase; drug safety; fever; follow up; hematuria; human; human tissue; laboratory test; leukocyturia; maximum tolerated dose; non muscle invasive bladder cancer; open study; phase 2 clinical trial; priority journal; proteinuria; recurrence risk; side effect; transurethral resection; tumor biopsy; tumor regression; urinary tract infection; clinical trial; intravesical drug administration; pathology; phase 1 clinical trial; tumor invasion

Citation Information

Scopus Citations: 17

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