- Intravesical chemoablation in patients with low-risk nonmuscle invasive bladder cancer (NMIBC) is feasible and safe, but fails to achieve prespecified responses.
- Chemoablation was associated with lower subsequent recurrences in nonresponders.
Why this matters
- A more intensive or extended chemoablation regimen may result in improved response rates, and any future research should consider this.
- Phase 2 CALIBER study: 82 patients with low-risk NMIBC were randomly assigned (2:1) to chemoablation with mitomycin or surgical management.
- Funding: National Institute for Health Research.
- Median follow-up: 24 months.
- Complete response at 3 months was 37% (95% CI, 24%-51%) with chemoablation and 81% (95% CI, 61%-93%) with surgical management.
- 12-month recurrence-free survival was 75.4% with surgery and 82.7% with chemoablation (HR, 0.44; P=.09).
- In patients with complete response at 3 months, subsequent recurrence-free survival at 12 months was 84.4% in each group.
- In patients with no complete response at 3 months, subsequent recurrence-free survival at 12 months was higher with chemoablation (81.9% vs 40.0%).
- Recruitment stopped early because chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months.
- No serious or grade 3-4 adverse events were reported.
- QoL was similar between the 2 groups.
- Underpowered for direct comparisons.