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Randomized Phase III Trial Comparing Retroperitoneal Lymph Node Dissection With One Course of Bleomycin and Etoposide Plus Cisplatin Chemotherapy in the Adjuvant Treatment of Clinical Stage I Nonseminomatous Testicular Germ Cell Tumors: AUO Trial AH 01/94 by the German Testicular Cancer Study Group

Journal of clinical oncology, 2008-06, Vol.26 (18), p.2966-2972 [Peer Reviewed Journal]

2008 INIST-CNRS ;ISSN: 0732-183X ;EISSN: 1527-7755 ;DOI: 10.1200/JCO.2007.12.0899 ;PMID: 18458040

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Title:
Randomized Phase III Trial Comparing Retroperitoneal Lymph Node Dissection With One Course of Bleomycin and Etoposide Plus Cisplatin Chemotherapy in the Adjuvant Treatment of Clinical Stage I Nonseminomatous Testicular Germ Cell Tumors: AUO Trial AH 01/94 by the German Testicular Cancer Study Group
Author: Albers, Peter ; Siener, Roswitha ; Krege, Susanne ; Schmelz, Hans-Uwe ; Dieckmann, Klaus-Peter ; Heidenreich, Axel ; Kwasny, Peter ; Pechoel, Maik ; Lehmann, Jan ; Kliesch, Sabine ; Köhrmann, Kai-Uwe ; Fimmers, Rolf ; Weissbach, Lothar ; Loy, Volker ; Wittekind, Christian ; Hartmann, Michael
Subjects: Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Bleomycin - administration & dosage ; Bleomycin - adverse effects ; Chemotherapy, Adjuvant ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Disease-Free Survival ; Etoposide - administration & dosage ; Etoposide - adverse effects ; Gynecology. Andrology. Obstetrics ; Humans ; Lymph Node Excision - adverse effects ; Lymph Node Excision - methods ; Male ; Male genital diseases ; Medical sciences ; Middle Aged ; Neoplasm Recurrence, Local - pathology ; Neoplasm Staging ; Neoplasms, Germ Cell and Embryonal - drug therapy ; Neoplasms, Germ Cell and Embryonal - pathology ; Neoplasms, Germ Cell and Embryonal - surgery ; Orchiectomy ; Testicular Neoplasms - drug therapy ; Testicular Neoplasms - pathology ; Testicular Neoplasms - surgery ; Tumors
Is Part Of: Journal of clinical oncology, 2008-06, Vol.26 (18), p.2966-2972
Description: Retroperitoneal lymph node dissection (RPLND) and adjuvant chemotherapy are two adjuvant treatment options for patients with clinical stage I nonseminomatous germ cell tumors of the testis (NSGCT). Aim of this trial was to prove the advantage of one cycle of bleomycin, etoposide, and cisplatin (BEP) chemotherapy compared with RPLND in terms of recurrence. Between 1996 and 2005, 382 patients were randomly assigned to receive either RPLND (n = 191) or one course of BEP (n = 191) after orchidectomy. The primary study end point was the rate of recurrence. The trial was powered to detect a 7% reduction (from 10% to 3%) of recurrence with chemotherapy compared with surgery. After a median follow-up of 4.7 years, two and 15 recurrences were observed in the intention-to-treat population with chemotherapy and surgery, respectively (P = .0011). The difference in the 2-year recurrence-free survival rate between chemotherapy (99.46%; 95% CI, 96.20% to 99.92%) and surgery (91.87%; 95% CI, 86.87% to 95.02%) was 7.59% (95% CI, 3.13% to 12.05%). The hazard ratio to experience a tumor recurrence with surgery as opposed to chemotherapy was 7.937 (95% CI, 1.808 to 34.48). To our knowledge, this is the largest randomized trial investigating adjuvant treatment strategies in clinical stage I NSGCT, which showed the superiority of one course BEP over RPLND performed according to community standards to prevent recurrence. Although not standard treatment, one course of BEP is active in an unselected group of patients with clinical stage I disease and merits further investigation.
Publisher: Baltimore, MD: American Society of Clinical Oncology
Language: English
Identifier: ISSN: 0732-183X
EISSN: 1527-7755
DOI: 10.1200/JCO.2007.12.0899
PMID: 18458040
Source: Geneva Foundation Free Medical Journals at publisher websites
MEDLINE
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Randomized Phase III Trial Comparing Retroperitoneal Lymph Node Dissection With One Course of Bleomycin and Etoposide Plus Cisplatin Chemotherapy in the Adjuvant Treatment of Clinical Stage I Nonseminomatous Testicular Germ Cell Tumors: AUO Trial AH 01/94 by the German Testicular Cancer Study Group

2008 INIST-CNRS ;ISSN: 0732-183X ;EISSN: 1527-7755 ;DOI: 10.1200/JCO.2007.12.0899 ;PMID: 18458040

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