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    Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST)

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    Authors
    Joffe, J. K.
    Cafferty, F. H.
    Murphy, L.
    Rustin, G. J. S.
    Sohaib, S. A.
    Gabe, R.
    Stenning, S. P.
    James, E.
    Noor, D.
    Wade, S.
    Schiavone, F.
    Swift, S.
    Dunwoodie, E.
    Hall, M.
    Sharma, A.
    Braybrooke, J.
    Shamash, J.
    Logue, J.
    Taylor, H. H.
    Hennig, I.
    White, J.
    Rudman, S.
    Worlding, J.
    Bloomfield, D.
    Faust, G.
    Glen, H.
    Jones, R.
    Seckl, M.
    MacDonald, G.
    Sreenivasan, T.
    Kumar, S.
    Protheroe, A.
    Venkitaraman, R.
    Mazhar, D.
    Coyle, V.
    Highley, M.
    Geldart, T.
    Laing, R.
    Kaplan, R. S.
    Huddart, R. A.
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    Issue Date
    2022
    
    Metadata
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    Abstract
    PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSION 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.
    Citation
    Joffe JK, Cafferty FH, Murphy L, Rustin GJS, Sohaib SA, Gabe R, et al. Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST). Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2022.
    Journal
    J Clin Oncol
    URI
    http://hdl.handle.net/10541/625165
    DOI
    10.1200/jco.21.01199
    PubMed ID
    35298280
    Additional Links
    https://dx.doi.org/10.1200/jco.21.01199
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/jco.21.01199
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