One cycle of adjuvant chemotherapy with bleomycin, etoposide and cisplatin (BEP) has shown superiority in recurrence-free survival over retroperitoneal lymph node dissection (RPLND) in patients with clinical stage (CS) I non-seminomatous germ cell tumours (NSGCTs) of the testis in the setting of a phase III trial. We report the recurrences and late toxicities of this study after 13 years of follow-up.
Questionnaires from 382 patients with CS I NSGCT treated with 1 cycle of adjuvant BEP (arm A) or RPLND + two cycles of adjuvant BEP in cases of pathological stage II disease (arm B) were evaluated regarding recurrences and late toxicity. Overall, information on recurrence status was available in 337 patients, and 170 questionnaires were evaluable for toxicity (arm A: 95; arm B: 75).
With a median follow-up of 13.8 years (0-22), 3 patients (1.6%) in arm A and 16 patients (8.4%) in arm B experienced recurrence. The 15-year PFS in arm A/B was 99% (CI 96-100%)/92% (CI 89-99%) (p = 0.0049). The 15-year OS in arm A/B was 93% (CI 87-97%)/93% (CI 86-97%) (p = 0.83). Eight patients (4.2%) in arm A and four patients (2.1%) in arm B showed metachronous secondary testicular cancer (p = 0.26). Five patients (2.6%) in arm A and four patients (2.1%) in arm B developed other malignancies. Toxicities were not significantly different apart from retrograde ejaculation, which occurred more frequently after RPLND (10% versus 24%, p = 0.01).
With long-term observation, one cycle of BEP remains superior to RPLND in preventing recurrence and was tolerated without any clinically relevant long-term toxicities.
European journal of cancer (Oxford, England : 1990). 2021 Aug 06 [Epub ahead of print]
Andreas Hiester, Anna Fingerhut, Günter Niegisch, Roswitha Siener, Susanne Krege, Hans-Ulrich Schmelz, Klaus-Peter Dieckmann, Axel Heidenreich, Peter Kwasny, Maik Pechoel, Jan Lehmann, Sabine Kliesch, Kai-Uwe Köhrmann, Rolf Fimmers, Volker Loy, Christian Wittekind, Michael Hartmann, Peter Albers
Department of Urology, Medical Faculty, University of Duesseldorf, Germany. Electronic address: ., Department of Urology, Medical Faculty, University of Duesseldorf, Germany., Department of Urology, University Hospital Bonn, Germany., Department of Urology, Kliniken Essen-Mitte, Essen, Germany., Department of Urology, Federal Armed Services Hospital, Koblenz, Germany., Department of Urology, Asklepios Klinik, Altona, Hamburg, Germany., Department of Urology, University Hospital, Cologne, Germany., Department of Urology, Städtisches Klinikum, Dortmund, Germany., Department of Urology, Ernst-Moritz Arndt University, Greifswald, Germany., Department of Urology, Städtisches Krankenhaus, Kiel, Germany., Department of Clinical and Surgical Andrology, University Hospital Münster, Germany., Department of Urology, Theresien Krankenhaus Mannheim, Germany., Department of Medical Biometry, Informatics, and Epidemiology, Bonn, Germany., Institute of Pathology, Vivantes Klinikum am Urban, Berlin, Germany., Institute of Pathology, University of Leipzig, Germany., Department of Urology, Military Hospital, Hamburg, Germany.