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CALIBER - A phase II randomised feasibility trial of chemoablation with mitomycin versus surgical management in low risk non-muscle invasive bladder cancer

Mostafid, AH; Porta, N; Cresswell, J; Griffiths, T; Kelly, JD; Penegar, SR; Davenport, K; ... Hall, E; + view all (2020) CALIBER - A phase II randomised feasibility trial of chemoablation with mitomycin versus surgical management in low risk non-muscle invasive bladder cancer. BJU International , 125 (6) pp. 817-826. 10.1111/bju.15038. Green open access

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Abstract

Objectives: To evaluate the activity of intravesical mitomycin‐C (MMC) to ablate recurrent low‐risk non‐muscle‐invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence. Patients and Methods: CALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once‐weekly MMC 40‐mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan–Meier methods. Results: Between February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low‐risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow‐up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3–51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6–93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence‐free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12‐month recurrence‐free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months. Conclusion: Intravesical chemoablation in low‐risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non‐responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.

Type: Article
Title: CALIBER - A phase II randomised feasibility trial of chemoablation with mitomycin versus surgical management in low risk non-muscle invasive bladder cancer
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1111/bju.15038
Publisher version: https://doi.org/10.1111/bju.15038
Language: English
Additional information: This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci > Department of Targeted Intervention
URI: https://discovery.ucl.ac.uk/id/eprint/10093279
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