Survival in stage I seminoma is almost 100%. Computed tomography (CT) surveillance is an international standard of care, avoiding adjuvant therapy. In this young population, minimizing irradiation is vital. The Trial of Imaging and Surveillance in Seminoma Testis (TRISST) assessed whether magnetic resonance images (MRIs) or a reduced scan schedule could be used without an unacceptable increase in advanced relapses.
A phase III, noninferiority, factorial trial. Eligible participants had undergone orchiectomy for stage I seminoma with no adjuvant therapy planned. Random assignment was to seven CTs (6, 12, 18, 24, 36, 48, and 60 months); seven MRIs (same schedule); three CTs (6, 18, and 36 months); or three MRIs. The primary outcome was 6-year incidence of Royal Marsden Hospital stage ≥ IIC relapse (> 5 cm), aiming to exclude increases ≥ 5.7% (from 5.7% to 11.4%) with MRI (v CT) or three scans (v 7); target N = 660, all contributing to both comparisons. Secondary outcomes include relapse ≥ 3 cm, disease-free survival, and overall survival. Intention-to-treat and per-protocol analyses were performed.
Six hundred sixty-nine patients enrolled (35 UK centers, 2008-2014); mean tumor size was 2.9 cm, and 358 (54%) were low risk (< 4 cm, no rete testis invasion). With a median follow-up of 72 months, 82 (12%) relapsed. Stage ≥ IIC relapse was rare (10 events). Although statistically noninferior, more events occurred with three scans (nine, 2.8%) versus seven scans (one, 0.3%): 2.5% absolute increase, 90% CI (1.0 to 4.1). Only 4/9 could have potentially been detected earlier with seven scans. Noninferiority of MRI versus CT was also shown; fewer events occurred with MRI (two [0.6%] v eight [2.6%]), 1.9% decrease (-3.5 to -0.3). Per-protocol analyses confirmed noninferiority. Five-year survival was 99%, with no tumor-related deaths.
Surveillance is a safe management approach-advanced relapse is rare, salvage treatment successful, and outcomes excellent, regardless of imaging frequency or modality. MRI can be recommended to reduce irradiation; and no adverse impact on long-term outcomes was seen with a reduced schedule.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2022 Mar 17 [Epub ahead of print]
Johnathan K Joffe, Fay H Cafferty, Laura Murphy, Gordon J S Rustin, Syed A Sohaib, Rhian Gabe, Sally P Stenning, Elizabeth James, Dipa Noor, Simona Wade, Francesca Schiavone, Sarah Swift, Elaine Dunwoodie, Marcia Hall, Anand Sharma, Jeremy Braybrooke, Jonathan Shamash, John Logue, Henry H Taylor, Ivo Hennig, Jeff White, Sarah Rudman, Jane Worlding, David Bloomfield, Guy Faust, Hilary Glen, Rachel Jones, Michael Seckl, Graham MacDonald, Thiagarajan Sreenivasan, Satish Kumar, Andrew Protheroe, Ramachandran Venkitaraman, Danish Mazhar, Victoria Coyle, Martin Highley, Tom Geldart, Robert Laing, Richard S Kaplan, Robert A Huddart, TRISST Trial Management Group and Investigators
St James University Hospital, Leeds, United Kingdom., MRC Clinical Trials Unit at UCL, London, United Kingdom., Mount Vernon Hospital, Northwood, United Kingdom., Institute of Cancer Research, Royal Marsden Hospital, Sutton, United Kingdom., Centre for Cancer Prevention, Queen Mary University of London, London, United Kingdom., Bristol Haematology & Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom., Barts Cancer Institute, St Bartholomews Hospital, London, United Kingdom., The Christie Hospital, Manchester, United Kingdom., Kent Oncology Centre, Maidstone Hospital, Maidstone, United Kingdom., Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom., Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom., Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom., University Hospital Coventry and Warwickshire, Coventry, United Kingdom., Royal Sussex County Hospital, Sussex Cancer Centre, Brighton, United Kingdom., Northampton General Hospital, Northampton, United Kingdom., University Hospital Ayr, Ayr, United Kingdom., Singleton Hospital, Swansea, United Kingdom., Charing Cross Hospital, London, United Kingdom., Aberdeen Royal Infirmary, Aberdeen, United Kingdom., Lincoln County Hospital, Lincoln, United Kingdom., Velindre Hospital, Cardiff, United Kingdom., Churchill Hospital, Oxford, United Kingdom., Ipswich Hospital, Ipswich, United Kingdom., Addenbrooke's Hospital, Cambridge, United Kingdom., Belfast City Hospital, Belfast, United Kingdom., Derriford Hospital, Plymouth, United Kingdom., University Hospitals Dorset, Poole, United Kingdom., Royal Surrey County Hospital, Guildford, United Kingdom.