@Article{,
AUTHOR = {Cory A. Taylor, Conrad M. Tobert, Richard J. Kahnoski, John E. Humphrey, Brian R. Lane},
TITLE = {The value of a comprehensive primary outcome – results of a negative randomized control trial in the non-muscle invasive bladder cancer population},
JOURNAL = {Canadian Journal of Urology},
VOLUME = {28},
YEAR = {2021},
NUMBER = {4},
PAGES = {10756--10761},
URL = {http://www.techscience.com/CJU/v28n4/60281},
ISSN = {1488-5581},
ABSTRACT = {<b>Introduction:</b> American Urological Association (AUA) guidelines recommend intravesical chemotherapy to be given following transurethral resection of a bladder tumor. Prior studies have shown the benefit of mitomycin as well as gemcitabine. However, no study has compared the two agents.<br/>
<b>Materials and methods:</b> The study was designed as an open label 1:1:1 randomized controlled trial, comparing intravesical mitomycin, gemcitabine, and saline as a single intraoperative instillation immediately following transurethral resection of suspected bladder tumor. Primary endpoint was any grade ≥ 3 events according to NCI CTCAE Version 4.03, this captures any return trip to the operating room for recurrence of cancer or other event (benign bladder/urethra). Secondary endpoints were progression-free survival for urothelial cell carcinoma and adverse events.<br/>
<b>Results:</b> A total of 82 patients were enrolled and randomized, unfortunately the trial was suspended early due to protocol deviations. In an intention-to-treat analysis, freedom from grade > 3 events at 2 years was 74.8% in the no treatment arm, 51.0% in the mitomycin arm, and 56.0% in the gemcitabine arm (p = 0.81). Freedom from cancer recurrence for all patients was 62.3%. In the no treatment arm, it was 78.8%, and 50.7% and 63.6% in the mitomycin arm and gemcitabine arm respectively (p = 0.28). In a univariate analysis, the only patient variable significantly associated with the primary outcome was pathologic T stage (p < 0.002).<br/>
<b>Conclusion:</b> This study provides an example of a novel, patient-centered primary outcome with the goal of determining which treatment paradigms provide the greatest oncologic and clinical benefit.},
DOI = {}
}