Symptom-guided reduction of BCG dwell time: findings from the north-REG randomized trial.
Lene Munk, Josephine Maria Hyldgaard, Vanaja Kumasegaram et al.
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In 30 seconds
The multinational North-REG randomized controlled trial evaluated whether symptom-guided reductions in Bacillus Calmette-Guérin (BCG) dwell time could lessen toxicity in patients with non-muscle invasive bladder cancer. Among 225 participants reporting symptoms daily during induction and maintenance, the intervention used symptom severity to reduce dwell time from 120 minutes to 60 or 30 minutes; controls remained at 120 minutes. The intervention was associated with lower urgency during induction and fewer systemic symptoms and less fatigue at a maintenance assessment. Completion of the 15-instillation protocol was similar: 38% with symptom-guided reductions and 40% with standard dwell time.
Key findings
- Urgency during induction was lower with the intervention at week 3 (34% vs. 47%, P = 0.04) and week 6 (32% vs. 49%, P = 0.01).
- At week 9 of maintenance, systemic symptoms occurred in 30% vs. 61% (P < 0.001), and fatigue in 22% vs. 47% (P = 0.001), intervention vs. control.
- Completion of the 15-instillation protocol was 38% in the intervention group and 40% in the control group.
Why it matters
BCG treatment can occur against a substantial pre-existing symptom burden, and toxicity may vary over treatment. These trial findings suggest that monitoring symptoms and adapting dwell time may reduce selected local and systemic symptoms. The similar completion rates indicate that symptom reduction did not translate into an apparent improvement in protocol completion in this study.
What to keep in mind
Total adherence to the 15-instillation protocol was low and similar between groups; symptom-guided dwell-time reduction did not improve treatment completion.