Kamat - Figure 24
International Bladder Cancer Group: Definitions
FIG. 24: Since it is crucial in single-arm studies to have benchmarks that the community and regulatory bodies can agree on, the IBCG has provided these benchmarks, based on studies such as those described earlier and others from the EORTC.[21] For patients who are BCG-unresponsive and have CIS, an initial complete response rate of 50% at 6 months should be considered clinically relevant, and this should be durable to ≥30% at 12 months and 25% at 18 months. For patients who are BCG-unresponsive and have papillary disease, the recurrence-free rate should be ≥30% at 12 months and 25% at 18 months.
References
Kamat AM, Sylvester RJ, Böhle A, et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: recommendations from the International Bladder Cancer Group. J Clin Oncol. 2016;34:1935−44 https://doi.org/10.1200/JCO.2015.64.4070
