Testis Cancer A Nationwide Cohort Study of Stage I Seminoma Patients Followed on a Surveillance Program Mette Saksø Mortensen a, *, Jakob Lauritsen a , Maria Gry Gundgaard a,b , Mads Agerbæk c , Niels Vilstrup Holm d , Ib Jarle Christensen e , Hans von der Maase a , Gedske Daugaard a a Department of Oncology, Copenhagen University Hospital, Copenhagen, Denmark; b Danish Cancer Society, Copenhagen, Denmark; c Department of Oncology, Aarhus University Hospital, Aarhus, Denmark; d Department of Oncology, Odense University Hospital, Odense, Denmark; e Finsen Laboratory, Rigshospitalet, and Biotech Research and Innovation Centre, University of Copenhagen, Copenhagen Biocenter, Copenhagen, Denmark 1. Introduction Conventional treatment with adjuvant radiotherapy for stage I seminoma has resulted in excellent cure rates. However, focus on morbidity and late effects, in particular the risk of secondary cancers, has made the continued use of adjuvant radiotherapy less attractive. An increasing number of guidelines now recommend surveillance as the preferred management option [1–5], but recent studies document that current patterns of care for stage I seminoma are still highly variable [6,7]. In 1984, a surveillance program for Danish patients with stage I seminoma was established. The current study presents the largest group of stage I seminoma patients EUROPEAN UROLOGY 66 (2014) 1172–1178 available at www.sciencedirect.com journal homepage: www.europeanurology.com Article info Article history: Accepted July 2, 2014 Keywords: Germ cell cancer Stage I seminoma Surveillance Abstract Background: Increasing concerns about late effects after adjuvant treatment for stage I seminoma have made surveillance an attractive alternative. Objective: To evaluate the surveillance strategy in a nationwide cohort study. Design, setting, and participants: A retrospective, population-based study of Danish patients diagnosed with stage I seminoma between 1984 and 2008 and followed for 5 yr (n = 1954). Patient data were linked with national registries on November 30, 2012, to obtain information on late relapse, vital status, and cause of death. Outcome measurements and statistical analysis: Disease-specific survival (DSS), overall survival, relapse rates, time to relapse, detection of relapse, and prognostic factors for relapse were described for the cohort. The Kaplan-Meier method was used to determine survival probabilities. A Cox proportional hazards model was used for multivariate analysis of prognostic factors. Results and limitations: Median follow-up time was 15.1 yr. In total, 369 patients relapsed after a median 13.7 mo. DSS after 15 yr was 99.3%. Tumor size was a significant factor for relapse. Either vascular invasion or invasion of epididymis was significant if the other factor was excluded from analysis. Limitations include the retrospective nature of the study and the number of missing values in analysis. Conclusions: In the world’s largest study of stage I seminoma patients, we found surveillance to be a safe alternative to adjuvant therapies. Tumor size was a significant factor for relapse, together with either invasion of epididymis or vascular invasion. Patient summary: In this nationwide study, we looked at the outcomes of patients with stage I seminoma followed for 5 yr. We found that surveillance is a safe alternative to adjuvant treatment. # 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Department of Oncology 5073, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark. Tel. +45 51701413; Fax: +45 35453990. E-mail address: mette.saksoe.mortensen@regionh.dk (M.S. Mortensen). http://dx.doi.org/10.1016/j.eururo.2014.07.001 0302-2838/# 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.