Gierth, Michael and Breyer, J. and Zeman, F. and Fritsche, H. M. and Cordes, J. and Karl, A. and Zaak, D. and Stenzl, A. and von Schmeling, I. Kausch and Sommerhuber, A. and Zierer, T. and Burger, M. and Mayr, R. (2021) The HELENA study: Hexvix (R) TURB vs. white-light TURB followed by intravesical adjuvant chemotherapy-a prospective randomized controlled open-label multicenter non-inferiority study. WORLD JOURNAL OF UROLOGY, 39 (10). pp. 3799-3805. ISSN 0724-4983, 1433-8726
Full text not available from this repository. (Request a copy)Abstract
Purpose Photodynamic diagnosis and white-light TURB with adjuvant intravesical chemotherapy (ICT) is widely used in treatment of bladder cancer. This non-inferiority trial is designed to demonstrate non-inferiority regarding recurrence-free survival (RFS) of Hexvix(R) TURB followed by immediate instillation compared to white-light TURB with immediate instillation followed by maintenance ICT. Methods Between 07/2010 and 12/2016, 129 patients with EORTC intermediate risk non-muscle invasive bladder cancer treated with TURB were included in this multicentre phase III study. Patients were randomized and received either white-light TURB with immediate ICT followed by maintenance ICT (n = 62, 20 mg Mitomycin weekly for 6 weeks as induction phase, afterwards 20 mg/month for 6 months) or Hexvix (R) TURB with immediate ICT only (n = 67, 40 mg Mitomycin). Primary study endpoint was RFS after 12 months. Hexvix (R) TURB was counted as non-inferior to white light alone if the upper limit of the one-sided 95% confidence interval of hazard ratio was lower than 1.676. Due to the non-inferiority design, the per-protocol population was used as the primary analysis population (n = 113) Results Median follow-up was 1.81 years. Hexvix (R) group showed more events (recurrence or death) than white-light group (19 vs. 10) resulting in a HR of 1.29 (upper limit of one-sided 95%-CI = 2.45; p(non-inferiority) = 0.249). The ITT population yielded similar results (HR = 1.67); 3.18], p(non-inferiority) = 0.493). There was no significant difference in overall survival between both groups (p = 0.257). Conclusion Non-inferiority of Hexvix (R) TURB relative to white-light TURB with maintenance Mitomycin instillation in intermediate risk urothelial carcinoma of the bladder was not proven. Hence a higher effect of maintenance ICT is to assume compared to a Hexvix (R)-improved TURB only, confirming its important role in patient treatment.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | INVASIVE BLADDER-CANCER; GUIDED FLUORESCENCE CYSTOSCOPY; PHOTODYNAMIC DIAGNOSIS; TRANSURETHRAL RESECTION; RECURRENCE RATE; TA; CARCINOMA; RISK; METAANALYSIS; Urothelial carcinoma; Bladder cancer; Intravesical chemotherapy; Transurethral resection |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Urologie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 06 Sep 2022 09:04 |
| Last Modified: | 06 Sep 2022 09:04 |
| URI: | https://pred.uni-regensburg.de/id/eprint/46700 |
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