Prospective phase II study to evaluate response to two induction courses (12 intravesical instillations) of BCG therapy for high-risk non–muscle-invasive bladder cancer Journal Article

   

Authors:	Herr, H.; Vertosick, E. A.; Dalbagni, G.; Cha, E. K.; Smith, R.; Benfante, N.; Sjoberg, D. D.; Sfakianos, J. P.
Article Title:	Prospective phase II study to evaluate response to two induction courses (12 intravesical instillations) of BCG therapy for high-risk non–muscle-invasive bladder cancer
Abstract:	Objective: To test whether 2 sequential BCG-induction courses improve the response of high-risk non–muscle invasive bladder cancer. Achieving a complete response (CR) to BCG is critical to disease-free survival. Patients with preexisting BCG-specific immunity owing to prior exposure to BCG have longer disease-free survival than BCG-naïve patients likely due to heterologous immunity from the initial priming of the immune system. We evaluated this hypothesis in a phase II prospective clinical trial. Methods: From 2015 to 2018, we recruited patients with primary or recurrent NMIBC (high-grade Ta, T1 tumors, with or without CIS) to receive 2-induction courses (12 intra-vesical instillations) of BCG. The primary aim of the study was CR rate 6 months after start of the first BCG induction. CR was defined as no tumor at cystoscopy or TURB biopsy. No maintenance BCG was given. We targeted at least 75 evaluable patients, and a CR of 80% or better was deemed significant. Results: Eighty-one patients agreed to participate. Five withdrew before starting BCG, leaving 76 evaluable patients. Sixty-three patients (83%) completed the 12 instillations on schedule. Of these, 62 patients (91%) had a CR at 6 months. None of the patients had tumor progression. Serious adverse event was seen in 1 patient (1%). Recurrence-free survival at 2 years after complete response was 85% (95% CI 77%, 95%). Conclusion: The high response rate in patients with high-risk non–muscle-invasive bladder cancer justifies 2 BCG induction cycles in current practice. © 2021 Elsevier Inc.
Keywords:	treatment response; aged; major clinical study; cancer growth; cancer grading; bcg vaccine; phase 2 clinical trial; clinical evaluation; cystoscopy; high risk population; transurethral resection; recurrence free survival; bladder biopsy; non muscle invasive bladder cancer; human; male; female; article
Journal Title:	Urology
Volume:	157
ISSN:	0090-4295
Publisher:	Elsevier Science, Inc.
Date Published:	2021-11-01
Start Page:	197
End Page:	200
Language:	English
DOI:	10.1016/j.urology.2021.06.032
PUBMED:	34274387
PROVIDER:	scopus
PMCID:	PMC9428818
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-85111756691&doi=10.1016%2fj.urology.2021.06.032&partnerID=40&md5=bcd4156e542c3187200a4f24090bc551
Notes:	Article -- Export Date: 1 February 2022 -- Source: Scopus

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