Originally published as JCO Early Release 10.1200/JCO.2007.12.0899 on May 5 2008

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Randomized Phase III Trial Comparing Retroperitoneal Lymph Node Dissection With One Course of Bleomycin and Etoposide Plus Cisplatin Chemotherapy in the Adjuvant Treatment of Clinical Stage I Nonseminomatous Testicular Germ Cell Tumors: AUO Trial AH 01/94 by the German Testicular Cancer Study Group

Peter Albers, Roswitha Siener, Susanne Krege, Hans-Uwe Schmelz, Klaus-Peter Dieckmann, Axel Heidenreich, Peter Kwasny, Maik Pechoel, Jan Lehmann, Sabine Kliesch, Kai-Uwe Köhrmann, Rolf Fimmers, Lothar Weiβbach, Volker Loy, Christian Wittekind, Michael Hartmann

From the Department of Urology, Klinikum Kassel GmbH, Kassel; Department of Urology, Bonn University; Institute of Medical Biometry, Informatics and Epidemiology, Bonn University, Bonn; Department of Urology, Essen University, Essen; Department of Urology, Military Hospital Ulm, Ulm; Department of Urology, Albertinen Hospital; Department of Urology, Military Hospital Hamburg, Hamburg; Department of Urology, Cologne University, Cologne; Department of Urology, Städtisches Klinikum Dortmund; Department of Urology, Greifswald University; Department of Urology, Homburg University; Department of Urology, Münster University; Department of Urology, Theresien Hospital, Mannheim; Division of Urology, Euromed Clinic, Fürth; Institute of Pathology, Vivantes Klinikum Berlin; and the Institute of Pathology, Leipzig University, Leipzig, Germany

Corresponding author: Peter Albers, MD, Department of Urology, Düsseldorf University, Moorenstr 5, D-40225 Düsseldorf, Germany; e-mail: sekurol{at}uni-duesseldorf.de

Purpose Retroperitoneal lymph node dissection (RPLND) and adjuvant chemotherapy are two adjuvant treatment options for patients with clinical stage I nonseminomatous germ cell tumors of the testis (NSGCT). Aim of this trial was to prove the advantage of one cycle of bleomycin, etoposide, and cisplatin (BEP) chemotherapy compared with RPLND in terms of recurrence.

Patients and Methods Between 1996 and 2005, 382 patients were randomly assigned to receive either RPLND (n = 191) or one course of BEP (n = 191) after orchidectomy. The primary study end point was the rate of recurrence. The trial was powered to detect a 7% reduction (from 10% to 3%) of recurrence with chemotherapy compared with surgery.

Results After a median follow-up of 4.7 years, two and 15 recurrences were observed in the intention-to-treat population with chemotherapy and surgery, respectively (P = .0011). The difference in the 2-year recurrence-free survival rate between chemotherapy (99.46%; 95% CI, 96.20% to 99.92%) and surgery (91.87%; 95% CI, 86.87% to 95.02%) was 7.59% (95% CI, 3.13% to 12.05%). The hazard ratio to experience a tumor recurrence with surgery as opposed to chemotherapy was 7.937 (95% CI, 1.808 to 34.48).

Conclusion To our knowledge, this is the largest randomized trial investigating adjuvant treatment strategies in clinical stage I NSGCT, which showed the superiority of one course BEP over RPLND performed according to community standards to prevent recurrence. Although not standard treatment, one course of BEP is active in an unselected group of patients with clinical stage I disease and merits further investigation.

Supported by Grant No. 70-2074 from the German Cancer Aid (Deutsche Krebshilfe). Randomized trial registration No. 141 German Cancer Society (Deutsche Krebsgesellschaft).

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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