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
© The Author(s), 2022..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Therapeutic advances in medical oncology - 14(2022) vom: 22., Seite 17588359221086813 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Bleomycin |
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| Anmerkungen: |
Date Revised 08.04.2022 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1177/17588359221086813 |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Dieckmann, Klaus-Peter |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1 |b outcome, safety, and risk factors for relapse in a population-based study |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Revised 08.04.2022 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © The Author(s), 2022. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a bleomycin | |
| 650 | 4 | |a cisplatin | |
| 650 | 4 | |a embryonal carcinoma | |
| 650 | 4 | |a etoposide | |
| 650 | 4 | |a germ-cell tumor | |
| 650 | 4 | |a local pathological stage | |
| 650 | 4 | |a lymphovascular invasion | |
| 650 | 4 | |a nonseminoma | |
| 700 | 1 | |a Pokrivcak, Tomas |e verfasserin |4 aut | |
| 700 | 1 | |a Geczi, Lajos |e verfasserin |4 aut | |
| 700 | 1 | |a Niehaus, David |e verfasserin |4 aut | |
| 700 | 1 | |a Dralle-Filiz, Inken |e verfasserin |4 aut | |
| 700 | 1 | |a Matthies, Cord |e verfasserin |4 aut | |
| 700 | 1 | |a Dienes, Tamas |e verfasserin |4 aut | |
| 700 | 1 | |a Zschäbitz, Stefanie |e verfasserin |4 aut | |
| 700 | 1 | |a Paffenholz, Pia |e verfasserin |4 aut | |
| 700 | 1 | |a Gschliesser, Tanja |e verfasserin |4 aut | |
| 700 | 1 | |a Pichler, Renate |e verfasserin |4 aut | |
| 700 | 1 | |a Mego, Michal |e verfasserin |4 aut | |
| 700 | 1 | |a Bader, Pia |e verfasserin |4 aut | |
| 700 | 1 | |a Zengerling, Friedemann |e verfasserin |4 aut | |
| 700 | 1 | |a Heinzelbecker, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a Krausewitz, Philipp |e verfasserin |4 aut | |
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| 700 | 1 | |a Aurilio, Gaetano |e verfasserin |4 aut | |
| 700 | 1 | |a Aksoy, Cem |e verfasserin |4 aut | |
| 700 | 1 | |a Hentrich, Marcus |e verfasserin |4 aut | |
| 700 | 1 | |a Seidel, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Törzsök, Péter |e verfasserin |4 aut | |
| 700 | 1 | |a Nestler, Tim |e verfasserin |4 aut | |
| 700 | 1 | |a Majewski, Matthaeus |e verfasserin |4 aut | |
| 700 | 1 | |a Hiester, Andreas |e verfasserin |4 aut | |
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| 700 | 1 | |a Vallet, Sonia |e verfasserin |4 aut | |
| 700 | 1 | |a Studentova, Hana |e verfasserin |4 aut | |
| 700 | 1 | |a Schönburg, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a Niedersüß-Beke, Dora |e verfasserin |4 aut | |
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| 700 | 1 | |a Wülfing, Christian |e verfasserin |4 aut | |
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| 700 | 1 | |a Pichlmeier, Uwe |e verfasserin |4 aut | |
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