Two-Weekly Accelerated Bep (Abep) Regimen As Induction Chemotherapy In Intermediate And Poor Prognosis Patients (Pts) With Nonseminomatous Germ Cell Tumors (Nsgct): Efficacy Results Of Phase Ii Trial

e15566 Background: Three-weekly BEP has been a standard of chemotherapy of advanced NSGCT for last two decades. We performed a phase II study to assess the efficacy and toxicity of two-weekly aBEP regimen in the first line treatment of NSGCT. Here we report efficacy results. Methods: Chemotherapy-naïve NSGCT pts with intermediate or poor prognosis (IGCCCG) received aBEP 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 mcg days 6-10. Four cycles of aBEP were administered every 2 weeks. The primary endpoint was 1-year PFS after completion of chemotherapy. The hypotheses being tested was Ho: p0 = pexp (p0= 0.65). Assuming pexp= 0.80 with a two-sided type I error of 0.05, a type II error of 0.2, patient drop-out rate of 10%, 61 pts were required. Results: From 2010 to 2013, 61 pts were treated. Intermediate and poor prognosis according IGCCCG had 36 (59%) and 25 (41%) of pts, respectively. In poor prognostic group mediastinal primary tumor had 7 (18%) pts, non-pulmonary visceral metastases - 12 (48%) pts. There were no toxic deaths. Safety results were reported elsewhere (ASCO 2014, #e15540). Median time of f.-up was 36 (5-58) months. 1-year PFS for all pts was 78%. In pts with intermediate and poor prognosis 3-year PFS was 88% and 48%, respectively. These results were similar with efficacy of 3-weekly BEP in our centre. Conclusions: Two-weekly BEP regimen can be safely administered to NSGCT pts with intermediate and poor prognosis. No clearly benefit in PFS was seen comparing with 3-weekly BEP in both prognostic groups.