Expected impact of MRI-related interreader variability on ProScreen prostate cancer screening trial: a pre-trial validation study

Cancer Imaging

Johanna Ronkainen¹  Tuomas Saarinen¹  Juha Oksala¹  Teuvo L. J. Tammela²  Kimmo Taari³  Tuomas P. Kilpeläinen⁴  Ronja Hietikko⁴  Antti Rannikko⁴  Kari Natunen⁵  Anssi Auvinen⁵  Ritja Savolainen⁶  Kirsty Ijäs⁶  Kati Lind⁶  Suvi Marjasuo⁶  Outi Oksanen⁶  Anu Kenttämies⁷  Tuomas Mirtti⁸ 

[1] Department of Radiology, Tampere University Hospital, Tampere, Finland;Department of Urology, Tampere University Hospital, Tampere, Finland;Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland;Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland;Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland;Faculty of Social Sciences, Tampere University, Tampere, Finland;HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland;HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland;Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland;HUSLAB Laboratory Services, Department of Pathology, HUS Helsinki University Hospital, Helsinki, Finland;

关键词: Prostate cancer;    Agreement;    Magnetic resonance imaging;    PI-RADS version 2;    Screening;   

DOI  :  10.1186/s40644-020-00351-w

来源: Springer

【 摘 要 】

BackgroundThe aim of this study is to investigate the potential impact of prostate magnetic resonance imaging (MRI) -related interreader variability on a population-based randomized prostate cancer screening trial (ProScreen).MethodsFrom January 2014 to January 2018, 100 men aged 50–63 years with clinical suspicion of prostate cancer (PCa) in Helsinki University Hospital underwent MRI. Nine radiologists individually reviewed the pseudonymized MRI scans of all 100 men in two ProScreen trial centers. All 100 men were biopsied according to a histological composite variable comprising radical prostatectomy histology (N = 38) or biopsy result within 1 year from the imaging (N = 62). Fleiss’ kappa (κ) was used to estimate the combined agreement between all individual radiologists. Sample data were subsequently extrapolated to 1000-men subgroups of the ProScreen cohort.ResultsAltogether 89% men of the 100-men sample were diagnosed with PCa within a median of 2.4 years of follow-up. Clinically significant PCa (csPCa) was identified in 76% men. For all PCa, mean sensitivity was 79% (SD ±10%, range 62–96%), and mean specificity 60% (SD ±22%, range 27–82%). For csPCa (Gleason Grade 2–5) MRI was equally sensitive (mean 82%, SD ±9%, range 67–97%) but less specific (mean 47%, SD ±20%, range 21–75%). Interreader agreement for any lesion was fair (κ 0.40) and for PI-RADS 4–5 lesions it was moderate (κ 0.60). Upon extrapolating these data, the average sensitivity and specificity to a screening positive subgroup of 1000 men from ProScreen with a 30% prevalence of csPCa, 639 would be biopsied. Of these, 244 men would be true positive, and 395 false positive. Moreover, 361 men would not be referred to biopsy and among these, 56 csPCas would be missed. The variation among the radiologists was broad as the least sensitive radiologist would have twice as many men biopsied and almost three times more men would undergo unnecessary biopsies. Although the most sensitive radiologist would miss only 2.6% of csPCa (false negatives), the least sensitive radiologist would miss every third.ConclusionsInterreader agreement was fair to moderate. The role of MRI in the ongoing ProScreen trial is crucial and has a substantial impact on the screening process.

【 授权许可】

CC BY