INTRODUCTION: Clinical stage 1 (CS1) nonseminomatous (NS) germ cell tumors involve a 30% probability of relapse upon surveillance. Adjuvant chemotherapy with one course of bleomycin, etoposide, and cisplatin (1xBEP) can reduce this risk to <5%. However, 1xBEP results are based solely on five controlled trials from high-volume centers. We analyzed the outcome in a real-life population. PATIENTS AND METHODS: In a multicentric international study, 423 NS CS1 patients receiving 1xBEP were retrospectively evaluated. Median follow-up was 37 (range, 6-89) months. Primary end points were relapse-free and overall survival evaluated after 5 years. We also looked at associations of relapse with clinico-pathological factors using stratified Kaplan-Meier methods and Cox regression models. Treatment modality and outcome of recurrences were analyzed descriptively. RESULTS: The 5-year relapse-free survival rate was 96.2%. Thirteen patients (3.1%; 95% confidence interval, 1.65-5.04%) relapsed after a median time of 13 months, of which 10 were salvaged (77%). Relapses were mostly confined to retroperitoneal nodes. Three patients succumbed, two to disease progression and one to toxicity of chemotherapy. Pathological stage >pT2 was significantly associated with relapse rate. CONCLUSION: The relapse rate of 3.1% found in this population of NS CS1 patients treated with 1xBEP at the routine care level was not inferior to the median rate of 2.3% reported from a meta-analysis of controlled trials. Also, the cure rate of relapses of 77% is consistent with the previously reported rate of 80%. This study clearly shows that the 1xBEP regimen represents a safe treatment for NS CS1 patients.

2nd Department of Oncology Faculty of Medicine Comenius University Bratislava Slovak Republic

Department of Comprehensive Cancer Care Masaryk Memorial Cancer Institute Masaryk University Brno Czech Republic

Department of Hematology and Oncology Red Cross Hospital Munich Germany

Department of Internal Medicine 2 Universitätsklinikum Krems Krems AustriaDepartment of Oncology Palacký University Medical School and Teaching Hospital Olomouc Czech Republic

Department of Medical Oncology Universitätsklinikum Heidelberg Heidelberg Germany

Department of Medical Oncology Wilhelminenspital Vienna Austria

Department of Oncology Charles University and Thomayer Hospital Prague Czech Republic

Department of Oncology Hematology and Bone Marrow Transplantation with Division of Pneumology University Medical Center Hamburg Eppendorf Hamburg Germany

Department of Oncology Palacký University Medical School and Teaching Hospital Olomouc Czech Republic

Department of Urology Albertinen Krankenhaus Hamburg Germany

Department of Urology and Andrology Paracelsus Medical University Salzburg Salzburg Austria

Department of Urology and Pediatric Urology Universitätsklinikum Bonn Bonn Germany

Department of Urology and Pediatric Urology University Medical Centre Saarland University Homburg Saar Germany

Department of Urology Asklepios Klinik Altona Hamburg Germany

Department of Urology Bundeswehrkrankenhaus Hamburg Hamburg Germany

Department of Urology Bundeswehrkrankenhaus Ulm Ulm Germany

Department of Urology Bundeswehrzentralkrankenhaus Koblenz Koblenz Germany

Department of Urology Central Hospital Bolzano Bolzano Italy

Department of Urology Evangelische Kliniken Essen Mitte Essen Germany

Department of Urology Heinrich Heine University Düsseldorf Düsseldorf Germany

Department of Urology Hodentumorzentrum Asklepios Klinik Altona Paul Ehrlich Straße 1 22763 Hamburg Germany

Department of Urology Klinikum Klagenfurt Klagenfurt Austria

Department of Urology Medical University of Innsbruck Innsbruck Austria

Department of Urology Städtisches Klinikum Karlsruhe Karlsruhe Germany

Department of Urology Universitätsklinikum Halle Germany

Department of Urology Universitätsklinikum Schleswig Holstein Lübeck Germany

Department of Urology Universitätsklinikum Ulm Ulm Germany

Department of Urology Uro Oncology Robot Assisted and Reconstructive Urologic Surgery University Hospital Cologne Cologne Germany

Division of Oncology Medical University of Graz Graz Austria

Institute of Medical Biometry and Epidemiology University Medical Center Hamburg Eppendorf Hamburg Germany

Klinik und Poliklinik für Urologie Medizinische Fakultät Carl Gustav Carus Technische Universität Dresden Dresden Germany

Martini Klinik University Medical Center Hamburg Eppendorf Hamburg Germany

Medical Oncology Division of Urogenital and Head and Neck Tumours IEO European Institute of Oncology IRCCS Milan Italy

National Institute of Oncology Budapest Hungary

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