Eight-year outcomes of a phase III randomized trial of conventional versus hypofractionated high-dose intensity modulated radiotherapy for prostate cancer (CRUK/06/016): Update from the CHHiP Trial.

Authors

null

David P. Dearnaley

Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, United Kingdom

David P. Dearnaley , Clare Griffin , Isabel Syndikus , Vincent Khoo , Alison Jane Birtle , Ananya Choudhury , Catherine Ferguson , John Graham , Joe O'Sullivan , Miguel Panades , Yvonne L. Rimmer , Christopher D. Scrase , John Staffurth , Clare Cruickshank , Shama Hassan , Julia Pugh , Emma Hall

Organizations

Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, United Kingdom, The Institute of Cancer Research, London, United Kingdom, Clatterbridge Cancer Centre, Wirral, United Kingdom, Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom, The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom, Sheffield Teaching Hospitals Foundation Trust, Sheffield, United Kingdom, Musgrove Park Hospital, Taunton, United Kingdom, Queen's University Belfast, Belfast, United Kingdom, Lincoln County Hospital, Lincoln, United Kingdom, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom, Ipswich Hospital NHS Trust, Ipswich, United Kingdom, Velindre Hospital, Cardiff University, Cardiff, United Kingdom

Research Funding

Other
Cancer Research UK, Department of Health (UK) and the National Institute for Health Research Cancer Research Network.

Background: CHHiP is a non-inferiority trial to determine efficacy and safety of hypofractionated radiotherapy for localised prostate cancer (PCa). Five year results indicated that moderate hypofractionation of 60 Gray (Gy)/20 fractions (f) was non-inferior to 74Gy/37f (Lancet Oncology, 2016). Moderate hypofractionation is now an international standard of care but with patients remaining at risk of recurrence for many years, information on long-term outcomes is important. Here we report pre-planned analysis of 8 year outcomes. Methods: Between October 2002 and June 2011, 3216 men with node negative T1b-T3a localised PCa with risk of seminal vesical involvement ≤30% were randomised (1:1:1 ratio) to 74Gy/37f (control), 60Gy/20f or 57Gy/19f. Androgen deprivation began at least 3 months prior to radiotherapy (RT) and continued until end of RT. The primary endpoint was time to biochemical failure (Phoenix consensus guidelines) or clinical failure (BCF). The non-inferiority design specified a critical hazard ratio (HR) of 1.208 for each hypofractionated schedule compared to 74Gy/37f. Late toxicity was assessed at 5 years by RTOG and LENT-SOM scales. Analysis was by intention-to-treat. Results: With a median follow up of 9.2 years, 8 year BCF-free rates (95% CI) were 74Gy: 80.6% (77.9%, 83.0%); 60Gy: 83.7% (81.2%, 85.9%) and 57Gy: 78.5% (75.8%, 81.0%). For 60Gy/20f, non-inferiority was confirmed: HR60=0.84 (90% CI 0.71, 0.99). For 57Gy/19f, non-inferiority could not be declared: HR57=1.17 (90% CI 1.00, 1.37). Clinician assessments of late toxicity were similar across groups. At 5 years, RTOG grade≥2 (G2+) bowel toxicity was observed in 14/879 (1.6%), 18/908 (2.0%) and 17/904 (1.9%) of the 74Gy, 60Gy and 57Gy groups respectively. RTOG G2+ bladder toxicity was observed in 17/879 (1.9%), 14/908 (1.5%) and 17/904 (1.9%) of the 74Gy, 60Gy and 57Gy groups respectively. Conclusions: With BCF rates over 80%, long-term follow-up confirms that 60Gy/20f is non-inferior to 74Gy/37f. Late side effects were very low across all groups. These results support the continued use of 60Gy/20f as standard of care for men with localised PCa. Clinical trial information: 97182923.

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Therapeutics

Clinical Trial Registration Number

97182923

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 325)

Abstract #

325

Poster Bd #

A5

Abstract Disclosures

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