Achim Rose1, Tarek El-Leithy2, Frank vom Dorp3, Ahmed Zakaria2, Andreas Eisenhardt4, Stephan Tschirdewahn5, Herbert Rübben5. 1. Department of Urology, HELIOS Marien Klinik, Duisburg, Germany. Electronic address: achim.rose@helios-kliniken.de. 2. Theodor Bilharz Research Institute, Cairo, Egypt. 3. Department of Urology, HELIOS Marien Klinik, Duisburg, Germany. 4. Praxis Urologie Rhein/Ruhr, Mülheim an der Ruhr, Germany. 5. 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.
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.
Authors: Gabriele Gamerith; Arno Amann; Bettina Schenk; Thomas Auer; Hans Lentzen; Dirk O Mügge; Katharina M Cima; Judith Löffler-Ragg; Wolfgang Hilbe; Heinz Zwierzina Journal: Oncol Lett Date: 2017-08-31 Impact factor: 2.967
Authors: Kathrin Wode; Johanna Hök Nordberg; Gunver S Kienle; Nils O Elander; Britt-Marie Bernhardson; Berit Sunde; Lena Sharp; Roger Henriksson; Per Fransson Journal: Trials Date: 2020-09-11 Impact factor: 2.279