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

• Published in: Therapeutic advances in medical oncology Vol. 14; p. 17588359221086813
• Main Authors: Dieckmann, Klaus-Peter, Pokrivcak, Tomas, Geczi, Lajos, Niehaus, David, Dralle-Filiz, Inken, Matthies, Cord, Dienes, Tamas, Zschäbitz, Stefanie, Paffenholz, Pia, Gschliesser, Tanja, Pichler, Renate, Mego, Michal, Bader, Pia, Zengerling, Friedemann, Heinzelbecker, Julia, Krausewitz, Philipp, Krege, Susanne, Aurilio, Gaetano, Aksoy, Cem, Hentrich, Marcus, Seidel, Christoph, Törzsök, Péter, Nestler, Tim, Majewski, Matthaeus, Hiester, Andreas, Buchler, Tomas, Vallet, Sonia, Studentova, Hana, Schönburg, Sandra, Niedersüß-Beke, Dora, Ring, Julia, Trenti, Emanuela, Heidenreich, Axel, Wülfing, Christian, Isbarn, Hendrik, Pichlmeier, Uwe, Pichler, Martin
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.03.2022; Sage Publications Ltd; SAGE Publishing
• Subjects: Adjuvant therapy; Bleomycin; Chemotherapy; Cisplatin; Clinical trials; Etoposide; Original Research; Patients; Population studies; Population-based studies; Regression analysis; Risk factors; Toxicity; Tumors; bleomycin; lymphovascular invasion; germ-cell tumor; etoposide; embryonal carcinoma; cisplatin; nonseminoma; local pathological stage
• ISSN: 1758-8359; 1758-8340; 1758-8359
• DOI: 10.1177/17588359221086813

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.