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The HELENA study: Hexvix®-TURB vs. white-light TURB followed by intravesical adjuvant chemotherapy—a prospective randomized controlled open-label multicenter non-inferiority study
Gierth, Michael
, Breyer, Johannes, Zeman, Florian, Fritsche, Hans-Martin, Cordes, J., Karl, A., Zaak, D., Stenzl, A., Kausch von Schmeling, I., Sommerhuber, A., Zierer, Thomas, Burger, Maximilian und Mayr, Roman
(2021)
The HELENA study: Hexvix®-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, S. 3799-3805.
Veröffentlichungsdatum dieses Volltextes: 19 Mai 2021 05:47
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.45814
Zusammenfassung
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. ...
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.
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| Dokumentenart | Artikel | ||||
| Titel eines Journals oder einer Zeitschrift | World Journal of Urology | ||||
| Verlag: | Springer | ||||
|---|---|---|---|---|---|
| Ort der Veröffentlichung: | NEW YORK | ||||
| Band: | 39 | ||||
| Seitenbereich: | S. 3799-3805 | ||||
| Datum | 17 Mai 2021 | ||||
| Institutionen | Medizin > Lehrstuhl für Urologie Medizin > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien | ||||
| Identifikationsnummer |
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| Stichwörter / 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 | ||||
| Dewey-Dezimal-Klassifikation | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin | ||||
| Status | Veröffentlicht | ||||
| Begutachtet | Ja, diese Version wurde begutachtet | ||||
| An der Universität Regensburg entstanden | Zum Teil | ||||
| URN der UB Regensburg | urn:nbn:de:bvb:355-epub-458143 | ||||
| Dokumenten-ID | 45814 |
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