JCU - Abstracts of the BAUS 2018 Scientific Meeting - June 2018 - 19

Abstracts
non-muscle invasive bladder cancer (NMIBC). Radical cystectomy is the Gold Standard for BCG-unresponsive
NMIBC, however many patients are unfit for or unwilling
to consider this option.The objective of the present study
was to assess the efficacy of hyperthermic intravesical
chemotherapy (HIVEC®) in this patient group.
Methods: From October 2014 to July 2017 NMIBC
patients who were defined BCG-unresponsive were prospectively included at three academic institutions. All
patients were planned to receive HIVEC® treatment, consisting of an induction phase followed by maintenance
therapy. Only patients who had a minimum of 5 HIVEC®
instillations were included in the present analysis. The primary outcome was recurrence-free survival (RFS).
Results: The study population consisted of 59 BCGunresponsive NMIBC patients (8% intermediate- and 92%
high-risk) of whom 55 underwent t5 HIVEC® treatments.
The median age and follow-up was 72 years and 9.0
months [IQR 7.1 - 19.5]. The overall recurrence rate was
58% and the mean RFS was 16.6 months [SE 2.1] (Fig.1). In
patients having carcinoma in situ (n= 36), the recurrence
rate was also 58% and the mean RFS was 16.2 months [SE
2.8]. Progression occurred in 3 patients and 2 patients
experienced severe side-effects (CTCAE >2).
Conclusions: HIVEC® seems a valid treatment option
for BCG-unresponsive intermediate- or high-risk NMIBC
patients. We report a mean RFS of >1 year, potentially
avoiding or postponing the need for radical surgery in
these patients.

19
Mostafid H1, Cresswell J2, Griffiths L3, Kelly J4, Knight
A5, Catto J6, Davenport K7, Feber A4, Knowles M8,
McGrath J9, Cooke P10, Masood S11, Goubar A12,
Penegar S12, Porta N12, Wiley L12, Lewis R12, Hall E12
1Royal Surrey County Hospital NHS Foundation Trust, Guildford,
UK, 2South Tees Hospitals NHS Foundation Trust, Middlesbrough,
UK, 3University Hospitals of Leicester NHS Trust, UK, 4University
College London Hospitals NHS Foundation Trust, UK, 5Patient
Representative, Hampshire, UK, 6University of Sheffield, UK,
7Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK,
8Leeds Teaching Hospitals NHS Trust, UK, 9Royal Devon and Exeter
NHS Foundation Trust, UK, 10The Royal Wolverhampton Hospitals
NHS Trust, UK, 11Medway NHS Trust, Gillingham, UK, 12The
Institute of Cancer Research, London, UK

Introduction: Mitomycin C (MMC) chemotherapy has a
well-defined safety profile and is used in the treatment of
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 low risk NMIBC.
Patients and Methods: CALIBER has a Simon two stage
design, incorporating a surgical control group to test feasibility of randomisation. Patients with recurrent low risk
NMIBC were randomised 2:1 to chemoablation (4x 40mg
weekly MMC) vs. surgery (standard of care). The primary
endpoint was complete response (CR) to chemoablation
by visual assessment and histological biopsy at 3 months
post-treatment, aiming at excluding CR rate <45% (Stage 1).
Results: 82 participants (54 chemoablation, 28 surgery)
were recruited from 37 UK centres (28/01/2015 to
04/09/2017). Feasibility of randomisation was demonstrated with acceptance rates of 55%. The stage 1 CR criterion was not met and the trial closed to recruitment in
September 2017. Estimated 3 month CR rate is 37.3%
(95% CI: 24.1, 51.9) in the chemoablation group and 80.8%
(95% CI: 60.6, 93.4) in the surgery group. No grade 3-4
toxicities were reported in either group.
Conclusions: Chemoablation with MMC is safe, however
did not meet prespecified activity levels to warrant further investigation. Whilst surgery appears more effective
in this setting, the proportion of patients with residual disease at 3 months suggests surgery alone may be suboptimal. Further research is required to determine the role of
chemoablation with other agents in patients with low risk
NMIBC.

P1-12: Figure 1. Recurrence free Survival of 55 BCGunresponsive patients who received t5 HIVEC® instillations

P1-14 Discharge of low-risk non-muscleinvasive bladder cancer: A national survey of
adherence to NICE guidelines in the UK

P1-13 Results of CALIBER: A phase II
randomised feasibility trial of chemoablation
versus surgical management in low risk nonmuscle invasive bladder cancer (NMIBC)

Malde S1, Mostafid H2, Mir-Kohler A1, Bagnall P3,
Taylor J4, Creswell J5, Catto J6
1Guy's and St Thomas' NHS Foundation Trust, London, United
Kingdom, 2Royal Surrey County Hospital, Guildford, United Kingdom,
3North Tyneside General Hospital, United Kingdom, 4Salford Royal

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