Reza Sari Motlagh1, Benjamin Pradere1,2, Keiichiro Mori1,3, Noriyoshi Miura1,4, Mohammad Abufaraj1,5,6, Shahrokh F Shariat1,5,7,8,9,10,11,12. 1. Department of Urology, Medical University of Vienna, Vienna, Austria. 2. Department of Urology, CHRU Tours, Francois Rabelais University, Tours, France. 3. Department of Urology, The Jikei University School of Medicine, Tokyo, Japan. 4. Department of Urology, Ehime University Graduate School of Medicine, Ehime, Japan. 5. Department of Special Surgery, Jordan University Hospital, The University of Jordan, Amman, Jordan. 6. The National Center for Diabetes, Endocrinology and Genetics, The University of Jordan, Amman, Jordan. 7. Department of Urology, Weil Cornell Medical College, New York, New York. 8. Department of Urology, University of Texas Southwestern, Dallas, Texas, USA. 9. Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria. 10. Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic. 11. European Association of Urology Research Foundation, Arnhem, Netherlands. 12. Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.
Abstract
PURPOSE OF REVIEW: Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) is a new definition including patients who failed intravesical BCG therapy and should not receive more BCG because of the very low efficacy and disproportionately poor prognosis. Radical cystectomy as the standard of care for these patients is associated with significant morbidity and altered quality of life. Therefore, the FDA has accepted phase II single-arm studies as a threshold to approve new agents in this setting. RECENT FINDINGS: Efforts to find an effective and safe bladder sparing strategy for BCG unresponsive patients have not been successful yet. Studies that assess nanoparticle-bound, combination or device-assisted intravesical chemotherapy to increase drug delivery and efficacy have been partly promising but suffer from limitations. Systemic immunotherapy such as checkpoint inhibitors therapy PD1/PDL1 and intravesical immunotherapy such as rAd-IFN/Syn3 have shown satisfactory efficacy so far. SUMMARY: Although this is much effort and enthusiasm, no bladder-sparing strategy has met the criteria set for the successful alternative to radical cystectomy in BCG unresponsive NMIBC. For BCG unresponsive patients who refuse or are unfit for radical cyctectomy, there is new hope arising with novel strategies limiting the threshold for clinical use and a multitude of promising agents in clinical trials.
PURPOSE OF REVIEW: Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) is a new definition including patients who failed intravesical BCG therapy and should not receive more BCG because of the very low efficacy and disproportionately poor prognosis. Radical cystectomy as the standard of care for these patients is associated with significant morbidity and altered quality of life. Therefore, the FDA has accepted phase II single-arm studies as a threshold to approve new agents in this setting. RECENT FINDINGS: Efforts to find an effective and safe bladder sparing strategy for BCG unresponsive patients have not been successful yet. Studies that assess nanoparticle-bound, combination or device-assisted intravesical chemotherapy to increase drug delivery and efficacy have been partly promising but suffer from limitations. Systemic immunotherapy such as checkpoint inhibitors therapy PD1/PDL1 and intravesical immunotherapy such as rAd-IFN/Syn3 have shown satisfactory efficacy so far. SUMMARY: Although this is much effort and enthusiasm, no bladder-sparing strategy has met the criteria set for the successful alternative to radical cystectomy in BCG unresponsive NMIBC. For BCG unresponsive patients who refuse or are unfit for radical cyctectomy, there is new hope arising with novel strategies limiting the threshold for clinical use and a multitude of promising agents in clinical trials.
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