Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study
2015; Lippincott Williams & Wilkins; Volume: 194; Issue: 4 Linguagem: Inglês
10.1016/j.juro.2015.04.073
ISSN1527-3792
AutoresAchim Rose, T. El-Leithy, F. vom Dorp, Ahmed S. Zakaria, A. Eisenhardt, Stephan Tschirdewahn, H. Rübben,
Tópico(s)Urinary Bladder and Prostate Research
ResumoNo AccessJournal of UrologyAdult Urology1 Oct 2015Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study Achim Rose, Tarek El-Leithy, Frank vom Dorp, Ahmed Zakaria, Andreas Eisenhardt, Stephan Tschirdewahn, and Herbert Rübben Achim RoseAchim Rose Department of Urology, HELIOS Marien Klinik, Duisburg, Germany , Tarek El-LeithyTarek El-Leithy Theodor Bilharz Research Institute, Cairo, Egypt , Frank vom DorpFrank vom Dorp Department of Urology, HELIOS Marien Klinik, Duisburg, Germany , Ahmed ZakariaAhmed Zakaria Theodor Bilharz Research Institute, Cairo, Egypt , Andreas EisenhardtAndreas Eisenhardt Praxis Urologie Rhein/Ruhr, Mülheim an der Ruhr, Germany , Stephan TschirdewahnStephan Tschirdewahn Department of Urology, University Hospital of Essen, Essen, Germany , and Herbert RübbenHerbert Rübben Department of Urology, University Hospital of Essen, Essen, Germany View All Author Informationhttps://doi.org/10.1016/j.juro.2015.04.073AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail 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. References 1 : EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder, Update 2013. Eur Urol2013; 64: 639. Google Scholar 2 : A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage TaT1 bladder cancer: a meta-analysis of published results of randomized clinical trials. J Urol2004; 171: 2186. Link, Google Scholar 3 : High-grade Ta urothelial carcinoma and carcinoma in situ of the bladder. Urology2005; 66: 90. 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Google Scholar © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 194Issue 4October 2015Page: 939-943Supplementary Materials Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.Keywordsabnoba viscummistletoeurinary bladder neoplasmstreatment outcomeintravesicaladministrationMetricsAuthor Information Achim Rose Department of Urology, HELIOS Marien Klinik, Duisburg, Germany Financial interest and/or other relationship with Abnoba. More articles by this author Tarek El-Leithy Theodor Bilharz Research Institute, Cairo, Egypt Financial interest and/or other relationship with Abnoba. More articles by this author Frank vom Dorp Department of Urology, HELIOS Marien Klinik, Duisburg, Germany Financial interest and/or other relationship with Abnoba. More articles by this author Ahmed Zakaria Theodor Bilharz Research Institute, Cairo, Egypt Financial interest and/or other relationship with Abnoba. More articles by this author Andreas Eisenhardt Praxis Urologie Rhein/Ruhr, Mülheim an der Ruhr, Germany Financial interest and/or other relationship with Abnoba. More articles by this author Stephan Tschirdewahn Department of Urology, University Hospital of Essen, Essen, Germany Financial interest and/or other relationship with Abnoba. More articles by this author Herbert Rübben Department of Urology, University Hospital of Essen, Essen, Germany Financial interest and/or other relationship with Abnoba. More articles by this author Expand All Advertisement PDF downloadLoading ...
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