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Risk Factors for Relapse in Clinical Stage I Nonseminomatous Testicular Germ Cell Tumors: Results of the German Testicular Cancer Study Group Trial

Peter Albers, Roswitha Siener, Sabine Kliesch, Lothar Weissbach, Susanne Krege, Christoph Sparwasser, Harald Schulze, Axel Heidenreich, Werner de Riese, Volker Loy, Erhard Bierhoff, Christian Wittekind, Rolf Fimmers, Michael Hartmann

From the Departments of Urology and Medical Biometry, Bonn University, Bonn; Department of Urology, Münster University, Münster; Department of Urology and Institute of Pathology, Krankenhaus am Urban, Berlin; Department of Urology, Essen University, and Institute of Pathology Essen-Mitte, Essen; Department of Urology, Military Hospital, Ulm; Department of Urology, Städtische Kliniken, Dortmund; Department of Urology, Marburg University, Marburg; Institute of Pathology, Leipzig University, Leipzig; Department of Urology, Military Hospital, Hamburg, Germany; and Division of Urology, Texas Tech University, Lubbock, TX.

Address reprint requests to Peter Albers, MD, Department of Urology, Bonn University, D-53105 Bonn, Germany; email: peter.albers{at}ukb.uni-bonn.de.

Purpose: To prospectively assess potential risk factors for relapse in clinical stage I nonseminomatous germ cell tumors of the testis (CS I NSGCT).

Patients and Methods: From September 1996 to May 2002, 200 patients with CS I NSGCT were prospectively assigned to retroperitoneal lymph node dissection (RPLND), and risk factor assessment was performed within a multicenter protocol. One hundred sixty-five patients had an adequate minimum follow-up of 12 months (mean, 34.5 months) or had pathologic stage II.

Results: Pathologic stage II disease was found in 27.9% of patients. Only 0.6% of patients relapsed in the retroperitoneum after confirmation of pathologic stage I disease. With reference pathology, vascular invasion (VI) was most predictive of stage in multifactorial analysis (accuracy, 65.1%). However, the positive predictive value (PPV) of VI to predict patients who have metastatic disease or relapse during follow-up was only 52.7%. With absent VI, low-risk patients had a negative predictive value (NPV) of 76.9%. With a combination of several risk factors, the PPV increased to 63.6% and the negative predictive value increased to 86.5%.

Conclusion: Even with an optimal combination of prognostic factors and reference pathology, more than one third of patients predicted to have pathologic stage II or relapse during follow-up will not harbor metastatic disease and, therefore, would be overtreated with adjuvant therapy. However, patients at low risk may be predicted at an 86.5% level, and thus, surveillance in highly compliant patients would be a valuable option. For high-risk patients, further reduction of adjuvant treatment is necessary.

Supported by grants DFG Al 391/3-1 and DFG Al 391/3-2 from the Deutsche Forschungsgemeinschaft and by the Deutsche Krebshilfe, e. V. (trial no. DKH 70-7024).

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