12 month results of CALIBER: A phase II randomised feasibility trial of chemoablation with MMC versus surgical management in low risk (LR) non-muscle invasive bladder cancer (NMIBC)
BAUS ePoster online library. Campain N. Jun 24, 2019; 259513; P2-9
Mr. Nicholas Campain
Mr. Nicholas Campain
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Abstract
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Introduction
Mitomycin C (MMC) chemotherapy has a well-defined safety profile and is used to treat intermediate and high risk NMIBC. CALIBER aimed to demonstrate that intravesical MMC (chemoablation) had sufficient activity to warrant further investigation as an alternative to surgery for recurrent low risk (LR) NMIBC.

Materials & methods
CALIBER has a Simon two-stage design, incorporating a surgical control group to test feasibility of randomisation. Recurrent LR NMIBC patients were randomised 2:1 to chemoablation (4x 40mg weekly MMC) vs. surgery (standard of care). Primary endpoint is complete response (CR) to chemoablation at 3 months post-treatment, aiming to exclude CR rate <45% (Stage 1). Secondary endpoints include time to subsequent recurrence, toxicity and patient reported quality of life.

Results
82 participants (54 chemoablation, 28 surgery) were recruited (28/01/2015-04/09/2017). Median follow-up was 24 months (IQR 15-29). Stage 1 CR rate criterion was not met: 3-month CR rate: 37.0% (95% CI: 24.3-51.3, chemoablation) and 80.8% (95% CI: 60.6-93.4, surgery). The 12-month proportion free of subsequent recurrence was 82.9% (95% CI: 69.7-90.7, chemoablation) and 75.4% (95% CI: 53.2-88.2, surgery) (p=0.09). Patients with CR to chemoablation at 3 months had fewer subsequent recurrences than surgery patients without CR at 3 months.

Conclusions
Chemoablation in LR NMIBC is safe, but did not meet pre-specified activity levels. At 12-months follow-up, a reduction in subsequent recurrence rates was observed in the chemoablation arm. Results suggest a significant heterogeneity within the LR NMIBC population impacting outcomes and may be of therapeutic value requiring further investigation.
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