Long-term outcomes of accelerated BEP (bleomycin, etoposide, cisplatin) for advanced germ cell tumors: updated analysis of an Australian multicenter phase II trial.

Authors

null

Peter S. Grimison

Chris O'Brien Lifehouse, Sydney, Australia

Peter S. Grimison , Martin R. Stockler , Andrew James Martin , Luke Buizen , Nicola Jane Lawrence , Damien B. Thomson , Val Gebski , Michael Friedlander , Annie Yeung , Howard Gurney , Mark Rosenthal , Nimit Singhal , Ganessan Kichenadasse , Shirley S. Wong , Craig R. Lewis , Paul Austin Vasey , Guy C. Toner

Organizations

Chris O'Brien Lifehouse, Sydney, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia, Princess Alexandra Hospital, Brisbane Queensland, Australia, The Prince of Wales Hospital, Randwick, Australia, Westmead Hospital, Westmead, Australia, Royal Melbourne Hospital, Melbourne, Australia, Royal Adelaide Hospital, Adelaide, Australia, Flinders Medical Centre and Flinders Centre for Innovation in Cancer, Flinders University, Bedford Park South Australia, Australia, Western Hospital, Brunswick, Australia, Prince of Wales Hospital, Sydney, Australia, Wesley Medical Centre, Haematology and Oncology Clinics of Australasia, Brisbane, Australia, Peter MacCallum Cancer Centre, Melbourne, Australia

Research Funding

Other Foundation

Background: We performed a single arm, multi-center, phase II trial of accelerated (dose-dense) BEP as first-line chemotherapy for advanced germ-cell tumours. Accelerated BEP was found to be feasible and tolerable, with promising efficacy (Grimison et al, Ann Onc 2014). Here we report on outcomes given long-term follow-up. Methods: Patients with extra-cranial advanced germ cell tumours of any risk group and radiologically measurable disease received cisplatin 20mg/m2 and etoposide 100mg/m2 on days 1-5, and pegylated G-CSF 6mg on day 6, all repeated every 2 weeks for 4 cycles (3 cycles for good risk). Bleomycin was given at 30kIU weekly to a total 12 doses (9 doses for good risk). Primary endpoint was regimen feasibility (previously reported). Results: 43 eligible patents were enrolled between February 2008 and November 2010 from 14 Australian sites. 12 had poor-risk disease, 16 intermediate-risk, and 15 good-risk. With a data cut-off of 1NOV15, median follow-up was 6.2 years (interquartile range: 5.7-6.5) for survival and 6.2 years (interquartile range: 5.7-6.4) for relapse. 8 patients have relapsed. 2 relapses occurred within 3 months of enrolment (refractory disease), 6 relapses occurred between 3-15 months (early relapse), no late relapses occurred. 3 patients have died (all following relapse; 1 died due to an unrelated malignancy). 5-year progression-free survival was 50% (95% CI: 21%-74%) for poor-prognosis, 94% (95% CI: 65%-99%) for intermediate-prognosis and 93% (95% CI: 61%-99%) for good-prognosis patients. 5-year overall survival was 92% (95% CI: 54%-99%) for poor-prognosis, 94% (95% CI: 63%-99%) for intermediate-prognosis and 100% (95% CI: NA) for good-prognosis patients. Conclusions: The long-term efficacy data of accelerated BEP remains promising. This trial and a similar UK study provide the rationale for a currently recruiting Australian-led international randomised trial comparing accelerated versus standard BEP. Clinical trial information: 12607000294459.

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Germ Cell/Testicular

Clinical Trial Registration Number

12607000294459

Citation

J Clin Oncol 34, 2016 (suppl; abstr e16056)

DOI

10.1200/JCO.2016.34.15_suppl.e16056

Abstract #

e16056

Abstract Disclosures

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