Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1: outcome, safety, and risk factors for relapse in a population-based study
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Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1: outcome, safety, and risk factors for relapse in a population-based study. / Dieckmann, Klaus-Peter; Pokrivcak, Tomas; Geczi, Lajos; Niehaus, David; Dralle-Filiz, Inken; Matthies, Cord; Dienes, Tamas; Zschäbitz, Stefanie; Paffenholz, Pia; Gschliesser, Tanja; Pichler, Renate; Mego, Michal; Bader, Pia; Zengerling, Friedemann; Heinzelbecker, Julia; Krausewitz, Philipp; Krege, Susanne; Aurilio, Gaetano; Aksoy, Cem; Hentrich, Marcus; Seidel, Christoph; Törzsök, Péter; Nestler, Tim; Majewski, Matthaeus; Hiester, Andreas; Buchler, Tomas; Vallet, Sonia; Studentova, Hana; Schönburg, Sandra; Niedersüß-Beke, Dora; Ring, Julia; Trenti, Emanuela; Heidenreich, Axel; Wülfing, Christian; Isbarn, Hendrik; Pichlmeier, Uwe; Pichler, Martin.
In: THER ADV MED ONCOL, Vol. 14, 2022, p. 17588359221086813.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1: outcome, safety, and risk factors for relapse in a population-based study
AU - Dieckmann, Klaus-Peter
AU - Pokrivcak, Tomas
AU - Geczi, Lajos
AU - Niehaus, David
AU - Dralle-Filiz, Inken
AU - Matthies, Cord
AU - Dienes, Tamas
AU - Zschäbitz, Stefanie
AU - Paffenholz, Pia
AU - Gschliesser, Tanja
AU - Pichler, Renate
AU - Mego, Michal
AU - Bader, Pia
AU - Zengerling, Friedemann
AU - Heinzelbecker, Julia
AU - Krausewitz, Philipp
AU - Krege, Susanne
AU - Aurilio, Gaetano
AU - Aksoy, Cem
AU - Hentrich, Marcus
AU - Seidel, Christoph
AU - Törzsök, Péter
AU - Nestler, Tim
AU - Majewski, Matthaeus
AU - Hiester, Andreas
AU - Buchler, Tomas
AU - Vallet, Sonia
AU - Studentova, Hana
AU - Schönburg, Sandra
AU - Niedersüß-Beke, Dora
AU - Ring, Julia
AU - Trenti, Emanuela
AU - Heidenreich, Axel
AU - Wülfing, Christian
AU - Isbarn, Hendrik
AU - Pichlmeier, Uwe
AU - Pichler, Martin
N1 - © The Author(s), 2022.
PY - 2022
Y1 - 2022
N2 - 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%) 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.
AB - 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%) 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.
U2 - 10.1177/17588359221086813
DO - 10.1177/17588359221086813
M3 - SCORING: Journal article
C2 - 35386956
VL - 14
SP - 17588359221086813
JO - THER ADV MED ONCOL
JF - THER ADV MED ONCOL
SN - 1758-8340
ER -