@article{Rose_Garcia-Perdomo_Bivalacqua_Witjes_Palou_Black_Steinberg_Lerner_Porten_Kamat_Li_2022, title={Systematic Review and Meta-Analysis of Response Rates in BCG-unresponsive Non–Muscle-Invasive Bladder Cancer: a Consensus Statement From the International Bladder Cancer Group}, volume={3}, url={https://siuj.org/index.php/siuj/article/view/208}, DOI={10.48083/10.48083/CKYL2827}, abstractNote={<p>There is a critical need to establish reference response rates following bladder-sparing therapies <br>administered in the setting of bacillus Calmete-Guerin (BCG)-unresponsive non–muscle-invasive bladder cancer <br>(NMIBC). We sought to determine the efficacy of different interventions in recent trials accruing <br>patients fulfilling the strict BCG- unresponsive definition established by the US Food and Drug <br>Administration. We performed a systematic review and meta-analysis for clinical trials in the <br>BCG-unresponsive disease space to include published and presented results. The primary endpoints <br>were complete response rate for CIS±Ta/T1 tumors, recurrence-free rate for patients with <br>papillary-only disease, and disease-free rate in studies enrolling both papillary CIS tumors <br>(Ta/T1/CIS). I2 was used for assessing heterogeneity. Eleven studies using 9 different therapeutic <br>agents in a total of 909 patients with BCG-unresponsive NMIBC were identified. The resulting <br>outcomes at 3, 6, and 12 months were 44%, 38%, and 25% complete response rate in CIS±Ta/T1 tumors; 73%, 58%, and 48% recurrence-free rate in <br>papillary-only; and 48%, 22%, and 43% disease-free rate in combined Ta/T1/CIS, respectively. Relatively low levels of <br>heterogeneity were observed amongst studies restricted to papillary-only or CIS±Ta/T1 tumors. <br>Future randomized controlled studies are needed and will likely require stratification between papillary-only and CIS±Ta/T1 tumors.</p&gt;}, number={5}, journal={Société Internationale d’Urologie Journal}, author={Rose, Kyle M. and Garcia-Perdomo, Herney A. and Bivalacqua, Trinity J. and Witjes, Alfred and Palou, Joan and Black, Peter C. and Steinberg, Gary D. and Lerner, Seth P. and Porten, Sima P. and Kamat, Ashish M. and Li, Roger}, year={2022}, month={Sep.}, pages={333-339} }