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    Therapeutic advances in medical oncology. 2022 Mar 31. doi: 10.1177/17588359221086813. pii: 10.1177_17588359221086813. pmc: PMC8977693
    Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1: outcome, safety, and risk factors for relapse in a population-based study.
    Dieckmann KP1,  Pokrivcak T2,  Geczi L3,  Niehaus D4,  Dralle-Filiz I5,  Matthies C6,  Dienes T7,  Zschäbitz S8,  Paffenholz P9,  Gschliesser T10,  Pichler R11,  Mego M12,  Bader P13,  Zengerling F14,  Heinzelbecker J15,  Krausewitz P16,  Krege S17,  Aurilio G18,  Aksoy C19,  Hentrich M20,  Seidel C21,  Törzsök P22,  Nestler T23,  Majewski M24,  Hiester A25,  Buchler T26,  Vallet S27,  Studentova H28,  Schönburg S29,  Niedersüß-Beke D30,  Ring J31,  Trenti E32,  Heidenreich A33,  Wülfing C34,  Isbarn H35,  Pichlmeier U36,  Pichler M37
    Author information
    1Department of Urology, Hodentumorzentrum, Asklepios Klinik Altona, Paul Ehrlich Straße 1, 22763 Hamburg, Germany.
    2Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Masaryk University, Brno, Czech Republic.
    3National Institute of Oncology, Budapest, Hungary.
    4Department of Urology, Asklepios Klinik Altona, Hamburg, Germany.
    5Department of Urology, Albertinen-Krankenhaus, Hamburg, Germany.
    6Department of Urology, Bundeswehrkrankenhaus Hamburg, Hamburg, Germany.
    7National Institute of Oncology, Budapest, Hungary.
    8Department of Medical Oncology, Universitätsklinikum Heidelberg, Heidelberg, Germany.
    9Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Urologic Surgery, University Hospital Cologne, Cologne, Germany.
    10Department of Urology, Klinikum Klagenfurt, Klagenfurt, Austria.
    11Department of Urology, Medical University of Innsbruck, Innsbruck, Austria.
    122nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic.
    13Department of Urology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.
    14Department of Urology, Universitätsklinikum Ulm, Ulm, Germany.
    15Department of Urology and Pediatric Urology, University Medical Centre, Saarland University, Homburg/Saar, Germany.
    16Department of Urology and Pediatric Urology, Universitätsklinikum Bonn, Bonn, Germany.
    17Department of Urology, Evangelische Kliniken Essen-Mitte, Essen, Germany.
    18Medical Oncology Division of Urogenital and Head and Neck Tumours, IEO, European Institute of Oncology IRCCS, Milan, Italy.
    19Klinik und Poliklinik für Urologie, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
    20Department of Hematology and Oncology, Red Cross Hospital, Munich, Germany.
    21Department of Oncology, Hematology and Bone Marrow Transplantation with Division of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
    22Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria.
    23Department of Urology, Bundeswehrzentralkrankenhaus Koblenz, Koblenz, Germany.
    24Department of Urology, Bundeswehrkrankenhaus Ulm, Ulm, Germany.
    25Department of Urology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
    26Department of Oncology, Charles University and Thomayer Hospital, Prague, Czech Republic.
    27Department of Internal Medicine II, Universitätsklinikum Krems, Krems, AustriaDepartment of Oncology, Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic.
    28Department of Oncology, Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic.
    29Department of Urology, Universitätsklinikum Halle (Saale), Halle (Saale), Germany.
    30Department of Medical Oncology, Wilhelminenspital, Vienna, Austria.
    31Department of Urology, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany.
    32Department of Urology, Central Hospital Bolzano, Bolzano, Italy.
    33Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Urologic Surgery, University Hospital Cologne, Cologne, Germany.
    34Department of Urology, Asklepios Klinik Altona, Hamburg, Germany.
    35Martini-Klinik, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
    36Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
    37Division of Oncology, Medical University of Graz, Graz, Austria.
    Abstract

    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.


    © The Author(s), 2022.

    KEYWORDS: bleomycin, cisplatin, embryonal carcinoma, etoposide, germ-cell tumor, local pathological stage, lymphovascular invasion, nonseminoma

    Publikations ID: 35386956
    Quelle: öffnen
     
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