NMIBC: intravesical chemoablation fails phase 2

  • Mostafid AH & al.
  • BJU Int
  • 3 Mar 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Underpowered for direct comparisons.