Klaus-Peter Dieckmann, Tomas Pokrivcak, Lajos Geczi, David Niehaus, Inken Dralle-Filiz, Cord Matthies, Tamas Dienes, Stefanie Zschäbitz, Pia Paffenholz, Tanja Gschliesser, Renate Pichler, Michal Mego, Pia Bader, Friedemann Zengerling, Julia Heinzelbecker, Philipp Krausewitz, Susanne Krege, Gaetano Aurilio, Cem Aksoy, Marcus Hentrich, Christoph Seidel, Péter Törzsök, Tim Nestler, Matthaeus Majewski, Andreas Hiester, Tomas Buchler, Sonia Vallet, Hana Studentova, Sandra Schönburg, Dora Niedersüß-Beke, Julia Ring, Emanuela Trenti, Axel Heidenreich, Christian Wülfing, Hendrik Isbarn, Uwe Pichlmeier, Martin Pichler
- 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%) relapsedIntroduction:
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.…
