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
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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