Dose-dense BEP (ddBEP) regimen as induction chemotherapy (CT) in intermediate and poor prognosis patients (pts) with nonseminomatous germ cell tumors (NSGCT): Safety results of phase II trial.

e15540 Background: BEP chemotherapy over three week cycles has been a standard CT regimen for advanced NSGCT for last two decades. We performed a phase II study to assess efficacy and toxicity of every-two-week ddBEP regimen in the first line treatment of NSGCT. Here we report safety results. Methods: CT-naive NSGCT pts with intermediate or poor prognosis (IGCCCG) received ddBEP as follows: cisplatin 20 mg/m2 days 1-5, etoposide 100 mg/m2 days 1-5, bleomycin 30 IU days 1,3,5 with G-CSF support 300 µg days 6-10. Four cycles of ddBEP were administered every 2 weeks. Frail pts with massive tumor burden were allowed to receive 1st cycle of ddBEP with dose reduction. Progression free rate at 1 year after completion of CT was the primary endpoint. The hypothesis being tested was Ho: p0 = pexp (p0=0.60). Assuming pexp=0.85 with a two-sided type I error of 0.05, a type II error of 0.2, a sample of 61 pts was required. Results: 61 pts were treated from 2010 to 2013. 36 (59%) and 25 (41%) of pts had intermediate an...