FIG. 23: Finally, the IBCG and the 2015 American Society of Clinical Oncology (ASCO) Genitourinary Cancers task force^[22] devised a term that has been adopted by several regulatory bodies called BCG-unresponsive disease.  This includes patients who are BCG refractory and those who have BCG-relapsing disease within 6 months of their last BCG exposure. 

Given that “BCG failure” is such an important term, it is important to emphasize once again that the definition of a patient who is BCG-unresponsive includes any patient who has persistent high-grade disease at 6 months despite adequate BCG treatment.^[21]  This includes

• patients who have stage or grade progression at 3 months after induction of BCG;
• any patient with recurrent high-grade disease within 6 months of the last exposure to BCG therapy.

This means that if a patient has been disease-free for 2 years, but the recurrence of high-grade disease was within 6 months of the last maintenance course of BCG, then this patient would also fall in the BCG-unresponsive category.  Clearly for clinical trial design purposes and for practical reasons, we can allow up to 9–12 months to account for delays in patients reaching us or accessing clinical trials.