PACE: Analysis of acute toxicity in PACE-B, an international phase III randomized controlled trial comparing stereotactic body radiotherapy (SBRT) to conventionally fractionated or moderately hypofractionated external beam radiotherapy (CFMHRT) for localized prostate cancer (LPCa).

Authors

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Nicholas John Van As

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

Nicholas John Van As , Douglas Brand , Alison Tree , Peter James Ostler , William Chu , Andrew Loblaw , Daniel Ford , Shaun P. Tolan , Suneil Jain , Alexander Stephen Martin , John Staffurth , Stephanie Brown , Stephanie M. Burnett , Aileen Duffton , Clare Griffin , Vicki Hinder , Kirsty Morrison , Olivia Frances Naismith , Emma Hall

Organizations

Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, United Kingdom, Institute of Cancer Research, London, United Kingdom, The Royal Marsden NHS Foundation Trust, London, United Kingdom, Mount Vernon Hospital, Dunstable, United Kingdom, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada, City Hospital, Cancer Centre Queen Elizabeth Hospital, Birmingham, United Kingdom, Clatterbridge Cancer Centre NHS Foundation, Wirral, United Kingdom, Queen's University, Belfast, United Kingdom, University of Southern California, Los Angeles, CA, Royal Marsden NHS Trust, Sutton, United Kingdom, Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, United Kingdom, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom, Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton, United Kingdom, Royal Marsden Hospital, London, United Kingdom, Royal Marsden NHS Foundation Trust, London, United Kingdom

Research Funding

Pharmaceutical/Biotech Company

Background: External beam radiotherapy (EBRT) is a curative treatment for LPCa. Large randomised controlled trials (RCTs) have shown moderately hypofractionated regimens (2.5–3 Gy/fraction(f)) as non-inferior to conventionally fractionated regimens (2 Gy/f). PACE-B aims to demonstrate non-inferiority of SBRT compared to CFMHRT for biochemical or clinical failure. Compared to CFMHRT, SBRT reduces patient (pt) attendances but compressed overall treatment time may influence acute toxicity severity. Methods: PACE is a phase III open-label multiple-cohort RCT. Men with LPCa, stage T1-T2, ≤ Gleason 3 + 4, PSA ≤ 20 ng/mL, unsuitable for surgery or preferring EBRT, were eligible for the PACE-B cohort. Between 08/12-01/18, 874 pts (38 centres) were randomised (1:1) to SBRT or CFMHRT. SBRT dose was 36.25 Gy/5f in 1-2 weeks (wks), CFMHRT as 78 Gy/39f over 7.5 wks, or 62 Gy/20f in 4 wks. Androgen deprivation therapy was not permitted. Clinician reported acute toxicity was assessed at baseline, 2-weekly during CFMHRT and at 2, 4, 8 & 12 wks post-treatment. Key toxicity outcomes were worst grade 2+ Radiation Therapy Oncology Group (RTOG) genitourinary (GU) and gastrointestinal (GI) acute toxicities, compared by Chi-square test with alpha 0.05 divided between the two measures. Results: By per protocol analysis n=430 received CFMHRT, n=414 received SBRT. Key characteristics seen in the CFMHRT and SBRT groups respectively were: mean age: 69.5 vs 69.3 years; T-stage ≥T2b: 51.8% vs 56.6%; Gleason Score 3+4: 80.2% vs 85.0%; PSA 10-20 ng/mL: 30.9% vs 31.6%. RTOG G2+ toxicity was not significantly different for GI events (CMFHRT 52/430 (12.1%) vs SBRT 42/414 (10.1%), p=0.368), nor GU events (CFMHRT 117/430 (27.2%) vs SBRT 96/414 (23.2%), p=0.179). Conclusions: Despite an accelerated treatment schedule, RTOG assessments show similar rates of acute GI and GU toxicity for SBRT and CFHFRT. Pt follow-up in PACE-B continues and results of late toxicity and biochemical/clinical failure are awaited. Clinical trial information: NCT01584258

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Abstract Details

Meeting

2019 Genitourinary Cancers Symposium

Session Type

General Session

Session Title

Welcome and General Session 1: Optimizing Diagnosis and Treatment of Clinically Significant Nonmetastatic Prostate Cancer

Track

Prostate Cancer

Sub Track

Prostate Cancer - Localized Disease

Clinical Trial Registration Number

NCT01584258

Citation

J Clin Oncol 37, 2019 (suppl 7S; abstr 1)

DOI

10.1200/JCO.2019.37.7_suppl.1

Abstract #

1

Abstract Disclosures