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

Albers, Peter; Siener, Roswitha; Krege, Susanne; Schmelz, Hans-Uwe; Dieckmann, Klaus‐Peter; Heidenreich, Axel; Kwasny, Peter; Pechoel, M.; Lehmann, Jan; Kliesch, Sabine; Köhrmann, K. U.; Fimmers, Rolf; Weiβbach, L.; Loy, V.; Wittekind, Christian; Hartmann, Michael

doi:10.1200/jco.2007.12.0899

Cited by 309 publications

(158 citation statements)

References 33 publications

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“…23,24 In a randomized, controlled study assessing the efficacy of primary RPLND versus a single cycle of bleomycin, etoposide, and platinum (cisplatin) (BEP), there was an unexpectedly high number of abdominal recurrences in the patients who were assigned to undergo primary RPLND. 25 We agree that a single cycle of BEP may have resulted in a lower recurrence rate than primary RPLND in the German randomized, controlled trial. However, recognizing that the number of cycles differ, van den Belt-Duesbout discovered that chemotherapy was associated with a greater risk of secondary malignancies, indicating the risks of chemotherapy as a management option for patients with clinical stage I disease.…”

Section: Discussionmentioning

confidence: 55%

Secondary malignancies among nonseminomatous germ cell tumor cancer survivors

Chamie

Kurzrock

Evans

et al. 2011

Cancer

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BACKGROUND: Men on active surveillance for clinical stage I nonseminomatous germ cell tumor (NSGCT) undergo frequent computed tomography imaging to avoid delayed detection of disease. Irradiation from frequent imaging and chemotherapy upon progression may place patients at increased risk of a second malignancy. In this study, the authors sought to identify such an increased risk among men who chose initial surveillance for NSGCT. METHODS: The authors utilized data from the Surveillance, Epidemiology and End Results Program and stratified the cohort based on whether they underwent retroperitoneal lymph node dissection (RPLND). A propensity-score model was used to adjust for covariates, and a competing-risks regression analysis was performed to estimate cumulative incidence rates of second malignancy. Incidence risk ratios were predicted by using the cumulative incidence rates per 10,000 patients. RESULTS: There was no statistically significant increase in the incidence of a secondary malignancy for the entire cohort of testicular cancer survivors. However, when the analysis was restricted to patients with clinical stage I NSGCT, nonsurgical management only in those aged >45 years was an independent predictor of developing a second malignancy. For every 10,000 patients with stage I NSGCT who chose to forego RPLND, an absolute excess incidence of 22, 52, and 73 secondary malignancies would be diagnosed at 5 years, 10 years, and 15 years, respectively. CONCLUSIONS: The current results indicated that patients aged >45 years who forego RPLND for T1 or T2 clinical stage I NSGCT are more likely to develop a second malignancy than those who do undergo RPLND. Nonsurgical management of NSGCT may be associated with more long-term health risks than primary RPLND. Cancer 2011;117:4219-30.

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Section: Discussionmentioning

confidence: 55%

Secondary malignancies among nonseminomatous germ cell tumor cancer survivors

Chamie

Kurzrock

Evans

et al. 2011

Cancer

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“…One course of BEP showed a significantly lower recurrence rate as compared to surgery [61]. If RPLND is performed in a multicentre setting, a higher rate of Binfield^recurrences and complications was reported [61,70]. Thus, nerve-sparing RPLND-if indicated-should be performed by an experienced surgeon in specialized centres.…”

Section: Retroperitoneal Lymph Node Dissectionmentioning

confidence: 98%

“…Following the failure of drug substitutions to convincingly reduce the toxicity of ACT, the next step was clearly to examine a single cycle of full dose (etoposide total dose 500 mg/sqM) BEP [58][59][60][61][62]. Very encouraging results were reported in the following two European studies:…”

Section: Bep (One Vs Two Cycles)mentioning

confidence: 99%

Current Concepts in Management of Stage I NSGCT

Ahluwalia

Gautam

2016

Indian J Surg Oncol

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While about 50% of non-seminomatous germ cell tumors of the testes present as clinical stage I (CSI), further management of these patients continues to be mired in controversy. Active surveillance is a frontline option for low-risk CS I patients and according to some, even the high-risk ones with high embryonal carcinoma (ECA) component and vascular invasion (VI). However, it carries the disadvantage of long-term surveillance, the need for prolonged chemotherapy in case of recurrence and the possibility of secondary malignancies due to radiation exposure from frequent CT scans. One or two cycles of BEP chemotherapy is a popular alternative to active surveillance which carries a very low relapse rate, but valid concerns about overtreatment of a majority of patients, with the attendant chemotherapy-related toxicity exist. Retroperitoneal lymph node dissection has been used as a means of avoiding chemotherapy, especially in high-risk patients, but carries the disadvantage of a high surgical morbidity and complications. As with any major surgical procedure, the best results are dependent on the experience and skill of the individual surgeon.

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“…The hazard ratio to experience a tumor recurrence with surgery as opposed to chemotherapy was 7.937 (95% CI, 1.808 to 34.48). BEP×1 needs to be compared with BEP×2 in a randomized trial to verify its safety and efficacy [6].…”

Section: Primary Chemotherapymentioning

confidence: 99%

Current Update of Management of Clinical Stage I Non Seminomatous Germ Cell Tumors of Testis

Yuvaraja

2012

Indian J Surg Oncol

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The management of patients with testicular germ cell tumors (GCT) has evolved significantly over the past 30 years with cure rates approaching nearly 100% for lowstage disease and more than 80% for advanced disease. Controversy surrounds about ideal management of clinical stage I non seminomatous germ cell tumors (CS I NSGCT) of the testis due to multiple treatment options available with more or less equal efficacy. Nerve-sparing retroperitoneal lymph node dissection (RPLND), adjuvant chemotherapy with two cycles of bleomycin, etoposide, and cisplatin , or surveillance have all achieved long-term survival in nearly 100% of patients with clinical stage I NSGCT. Retroperitoneal lymph node dissection is still favoured as the therapy of choice for clinical stage I non-seminomatous germ cell tumors in many centres, but as risk factors for the primary tumor have become better understood, surveillance and riskadapted therapy, including surveillance for low-risk patients and adjuvant chemotherapy for the high-risk group, is now being considered a therapeutic option. The objective of this study is to review current developments in the management of CS I NSGCT testis with emphasis on risk stratification and treatment recommendations.

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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

Cited by 309 publications

References 33 publications

Secondary malignancies among nonseminomatous germ cell tumor cancer survivors

Secondary malignancies among nonseminomatous germ cell tumor cancer survivors

Current Concepts in Management of Stage I NSGCT

Current Update of Management of Clinical Stage I Non Seminomatous Germ Cell Tumors of Testis

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