Surveillance of clinical stage I (CSI) testicular germ cell tumors (GCTs) is hampered by low sensitivity and specificity of current biomarkers for detecting relapses. This study evaluated if serum levels of microRNA371a-3p (M371 test) can (1) accurately detect relapses, (2) detect relapses earlier than conventional technology, and (3) if elevated postoperative M371 levels may predict relapse.
In a multicentric setting, 258 testicular CSI GCT patients were prospectively followed by surveillance for a median time of 18 months with serial measurements of serum M371 levels, in addition to standard diagnostic techniques. Diagnostic characteristics of M371 for detecting relapses were calculated using receiver operating characteristics curve (ROC) analysis.
Thirty-nine patients recurred (15.1%), all with elevated M371 levels, eight without relapse had elevations, too. The test revealed the following characteristics: area under the ROC curve of 0.993, sensitivity 100%, specificity 96.3%, positive predictive value 83%, negative predictive value 100%. Earlier relapse detection with the test was found in 28%, with non-significant median time gain to diagnosis. Postoperative M371 levels did not predict future relapse.
The sensitivity and specificity of the M371 test for detecting relapses in CSI GCTs are much superior to those of conventional diagnostics. However, post-orchiectomy M371 levels are not predictive of relapse, and there is no significant earlier relapse detection with the test. In all, there is clear evidence for the utility of the M371 test for relapse detection suggesting it may soon be ready for implementation into routine follow-up schedules for testicular GCT patients.
Clinical cancer research : an official journal of the American Association for Cancer Research. 2023 Nov 15 [Epub ahead of print]
Gazanfer Belge, Cansu Dumlupinar, Tim Nestler, Markus Klemke, Peter Törzsök, Emanuela Trenti, Renate Pichler, Wolfgang Loidl, Yue Che, Andreas Hiester, Cord Matthies, Martin Pichler, Pia Paffenholz, Luis Kluth, Mike Wenzel, Jörg Sommer, Julia Heinzelbecker, Philipp Schriefer, Alexander Winter, Friedemann Zengerling, Mario Wolfgang Kramer, Marie Lengert, Jana Frey, Axel Heidenreich, Christian Wülfing, Arlo Radtke, Klaus-Peter Dieckmann
University of Bremen, Bremen, Germany., University Hospital Cologne, Koblenz, Germany., Paracelsus Medical University, Salzburg University Hospital, Salzburg, Austria., Salzburg, Austria., Ospedale di Bolzano, Bolzano, Italy., Medical University of Innsbruck, Innsbruck, Austria., Ordensklinikum Linz GmbH Elisabethinen, Linz, Upperaustria, Austria., Urologische Universitätsklinik der Heinrich-Heine-Universität, Düsseldorf, Germany, Germany., Federal Armed Forces Hospital Hamburg, Hamburg, Germany., Medical University of Graz, Graz, Austria., University Hospital Cologne, Cologne, Germany., University Hospital Frankfurt, Goethe University Frankfurt am Main, Germany, Germany., St. Franziskus Krankenhaus Lohne, Germany, Germany., Saarland University Medical Centre and Saarland University, Homburg, Germany., Urologische Gemeinschaftspraxis, Buxtehude, Germany., University Hospital Oldenburg, Oldenburg, Germany, Germany., University Hospital Ulm, Germany., Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Germany, Germany., Mirdetect GmbH, Bremerhaven, Germany, Germany., University Hospital Cologne, Cologne, NRW, Germany., Asklepios Klinik Altona, Hamburg, Germany, Germany., Asklepios Klinik Altona, Germany.