{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T09:34:54Z","timestamp":1771061694183,"version":"3.50.1"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2021,5,17]],"date-time":"2021-05-17T00:00:00Z","timestamp":1621209600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,5,17]],"date-time":"2021-05-17T00:00:00Z","timestamp":1621209600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100005626","name":"Universit\u00e4t Regensburg","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005626","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["World J Urol"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>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<jats:sup>\u00ae<\/jats:sup> TURB followed by immediate instillation compared to white-light TURB with immediate instillation followed by maintenance ICT.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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 (<jats:italic>n<\/jats:italic>\u2009=\u200962, 20\u00a0mg Mitomycin weekly for 6\u00a0weeks as induction phase, afterwards 20\u00a0mg\/month for 6\u00a0months) or Hexvix<jats:sup>\u00ae<\/jats:sup> TURB with immediate ICT only (<jats:italic>n<\/jats:italic>\u2009=\u200967, 40\u00a0mg Mitomycin). Primary study endpoint was RFS after 12\u00a0months. Hexvix<jats:sup>\u00ae<\/jats:sup> 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 (<jats:italic>n<\/jats:italic>\u2009=\u2009113)<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Median follow-up was 1.81\u00a0years. Hexvix<jats:sup>\u00ae<\/jats:sup> 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\u2009=\u20092.45; <jats:italic>p<\/jats:italic><jats:sub>non-inferiority<\/jats:sub>\u2009=\u20090.249). The ITT population yielded similar results (HR\u2009=\u20091.67); 3.18], <jats:italic>p<\/jats:italic><jats:sub>non-inferiority<\/jats:sub>\u2009=\u20090.493). There was no significant difference in overall survival between both groups (<jats:italic>p<\/jats:italic>\u2009=\u20090.257).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Non-inferiority of Hexvix<jats:sup>\u00ae<\/jats:sup> 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<jats:sup>\u00ae<\/jats:sup>-improved TURB only, confirming its important role in patient treatment.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00345-021-03719-0","type":"journal-article","created":{"date-parts":[[2021,5,17]],"date-time":"2021-05-17T17:03:00Z","timestamp":1621270980000},"page":"3799-3805","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["The HELENA study: Hexvix\u00ae-TURB vs. white-light TURB followed by intravesical adjuvant chemotherapy\u2014a prospective randomized controlled open-label multicenter non-inferiority study"],"prefix":"10.1007","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6393-5899","authenticated-orcid":false,"given":"M.","family":"Gierth","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Breyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F.","family":"Zeman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H. 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Every participant gave informed consent for this study. All the findings, data acquisition and processing in this study comply with the ethical standards laid down in the latest declaration of Helsinki. The study was approved by the local ethics committee of the University of Regensburg (EudraCT-Nummer 2009-012275-98).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}