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Accelerated BEP for metastatic germ cell tumours: a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)

Grimison, Peter, Stockler, Martin, Chatfield, Mark, Thomson, D., Gebski, V., Friedlander, M., Boland, A., Houghton, Baerin, Gurney, H., Rosenthal, M., Singhal, N., Kichenadasse, G., Wong, S., Lewis, C., Vasey, P. and Toner, Guy (2014). Accelerated BEP for metastatic germ cell tumours: a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Annals of Oncology,25(1):143-148.

Document type: Journal Article
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IRMA ID cmartelxPUB128
Title Accelerated BEP for metastatic germ cell tumours: a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Author Grimison, Peter
Stockler, Martin
Chatfield, Mark
Thomson, D.
Gebski, V.
Friedlander, M.
Boland, A.
Houghton, Baerin
Gurney, H.
Rosenthal, M.
Singhal, N.
Kichenadasse, G.
Wong, S.
Lewis, C.
Vasey, P.
Toner, Guy
Journal Name Annals of Oncology
Publication Date 2014
Volume Number 25
Issue Number 1
ISSN 0923-7534   (check CDU catalogue open catalogue search in new window)
Scopus ID 2-s2.0-84905367678
Start Page 143
End Page 148
Total Pages 6
Place of Publication United Kingdom
Publisher Oxford University Press
HERDC Category C1 - Journal Article (DIISR)
Abstract Background
This Australian single-arm, multicenter, phase II trial evaluated feasibility, tolerability and activity of accelerated bleomycin, etoposide and cisplatin (BEP) as first-line chemotherapy for metastatic germ cell tumours.

Patients and methods
Patients were planned to receive cisplatin 20 mg/m2 and etoposide 100 mg/m2 days 1–5, and pegfilgrastim 6 mg day 6, all repeated every 2 weeks for four cycles (three cycles for good prognosis). Bleomycin was given at 30 000 IU weekly to a total of 12 doses (9 doses for good prognosis). Primary end point was feasibility, defined as the proportion of patients able to complete the etoposide and cisplatin components of BEP and be eligible to receive a fourth cycle of BEP by day 50.

Results
Twelve poor, 16 intermediate and 15 good prognosis (n = 43) eligible patients were enrolled. Two patients aged >40 years were ineligible and excluded from analyses. The regimen was feasible in 86%, not feasible in 7% and not assessable in 7% of patients. Most common grade 3/4 adverse events were non-neutropenic infection (16%) and febrile neutropenia (12%). Complete response (CR) to chemotherapy and surgery was achieved in 33% poor-prognosis, 81% intermediate-prognosis and 100% good-prognosis patients. At median follow-up of 27 months (range 6–42), the 2-year progression-free survival was 50% for poor-prognosis, 94% for intermediate-prognosis and 92% for good-prognosis patients.

Conclusion
Accelerated BEP is feasible and tolerable. Efficacy data appear to be promising. This trial and a similar UK study provide the rationale for a randomised trial comparing accelerated versus standard BEP. Australian New Zealand Clinical Trials Registry Registration number. ACTRN 12607000294459.

Keywords accelerated
antineoplastic combined chemotherapy
growth factors
germ cell tumours
testicular neoplasms
dose-density
DOI http://dx.doi.org/10.1093/annonc/mdt369   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
 
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Created: Thu, 07 Aug 2014, 17:19:43 CST