Vienna, Austria

ESTRO 2023

Session Item

Sunday
May 14
10:30 - 11:30
Plenary Hall
Genito-urinary
Daniel Matthias Aebersold, Switzerland;
Johannes Knoth, Austria
Proffered Papers
Clinical
10:30 - 10:40
Randomised phase II trial of adaptive image guided bladder radiotherapy: patient reported outcomes
Robert Huddart, United Kingdom
OC-0431

Abstract

Randomised phase II trial of adaptive image guided bladder radiotherapy: patient reported outcomes
Authors:

Robert Huddart1,2, Alison Birtle3, Ka Ching Cheung4, Ananya Choudhury5, Farshad Foroudi6, Hannah Gribble4, Clare Griffin4, Shaista Hafeez1,7, Emma Hall4, Ann Henry8, Ben Hindson9, Rebecca Lewis4, Duncan McLaren10, Helen McNair1,7, Ashok Nikapota11, Abdullahi Omar4, Omi Parikh12, Lara Philipps4, Isabel Syndikus13, Mohini Varughese14, Catalina Vassallo-Bonner15, Amanda Webster16

1The Institute of Cancer Research, Division of Radiotherapy and Imaging, London, United Kingdom; 2Royal Marsden Hospital NHS Foundation Trust, Radiotherapy Department, London, United Kingdom; 3Lancashire Teaching Hospitals NHS Foundation Trust, Cancer Oncology, Preston, United Kingdom; 4The Institute of Cancer Research, Clinical Trial and Statistics Unit, London, United Kingdom; 5The Christie NHS Foundation Trust, Translational Radiobiology, Manchester, United Kingdom; 6Austin Health, Radiation Oncology, Austin, Australia; 7The Royal Marsden NHS Foundation Trust, Radiotherapy Department, London, United Kingdom; 8Leeds Teaching Hospitals NHS Trust, Division of Cancer Studies and Pathology, Leeds, United Kingdom; 9Canterbury District Health Board, Department of Oncology Services, Christchurch, New Zealand; 10NHS Lothian, Department of Oncology, Edinburgh, United Kingdom; 11Brighton and Sussex University Hospital NHS Trust, Clinical Oncology, Brighton, United Kingdom; 12Lancashire Teaching Hospitals NHS Trust, Oncology, Burnley, United Kingdom; 13The Clatterbridge Cancer Centre, Department of Radiotherapy, Liverpool, United Kingdom; 14Royal Devon & Exeter NHS Foundation Trust, Department of Oncology, Exeter, United Kingdom; 15The Institute of Cancer Research, Patient representative, London, United Kingdom; 16University College Hospital (UCLH), National Radiotherapy Trials Quality Assurance Group (RTTQA), London, United Kingdom

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Purpose or Objective

Radiotherapy (RT) to the bladder is challenging as it is a mobile, deformable structure. Plan of the day (POD) adaptive image-guided RT and tumour boost dose escalation can optimise treatment. We aimed to define a feasible, safe schedule for muscle-invasive bladder cancer (BC) using these techniques.

Material and Methods

RAIDER (ISRCTN 26779187) is an international phase II trial. Participants (pts) had unifocal T2-T4a urothelial BC and were randomised (1:1:2) to standard whole bladder RT (WBRT), standard dose adaptive tumour focused RT (SART) or dose-escalated adaptive tumour boost RT (DART). Two fractionation (f) schedules recruited independently. WBRT & SART dose was 64Gy/32f or 55Gy/20f and DART was 70Gy/32f or 60Gy/20f. For SART & DART, POD (small, medium, large) was chosen daily. Patient-reported outcomes (PRO) included the King’s Health Questionnaire (KHQ) and EQ5D-5L as key secondary endpoints and PRO-CTCAE collected before, during and after RT. Standard algorithms were used to derive scores: EQ5D general health score, KHQ bladder problem score, KHQ symptom severity scale In each fractionation cohort, data are presented by treatment received in pts who received at least 1f RT.

Results

345 pts were randomised: 46/41 WBRT, 46/41 SART and 90/81 DART pts in 32f/20f cohorts respectively. 170 (93%) 32f and 149(91%) 20f pts consented to the PRO substudy and started RT. Baseline characteristics for 32f/20f were median age 73 years (IQR 68-79)/72 (67-79); 84%/77% T2; 46%/56% had NAC and 71%/70% concomitant radiosensitising treatment. Median follow-up was 32f: 38 months (m) (IQR 26-50), 20f: 42m (36-50). For 98% of SART/DART pts >1 RT plan was used with 3588/6222 (58%) fractions using adaptation (small or large plan). PRO reported at last RT fraction and at 12m are shown (table) with KHQ bladder problem ratings and PRO-CTCAE stool frequency at 12m (figure).

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Conclusion

Pts generally reported similar side effect profiles across treatment groups and fractionation cohorts. DART was well tolerated with no evidence of increased toxicity.