Phase II trial of dose-dense BEP for intermediate- and poor-prognosis metastatic germ cell tumors.

e15011 Background: Granulocyte colony-stimulating factor (G-CSF) permits shorter cycle intervals and increased dose density with potential for improved therapeutic ratio. We report a phase II study to assess the feasibility of an ‘accelerated’ dose-dense BEP regimen in male patients (pts) with germ cell tumors. Methods: Eligible pts with intermediate- and poor-prognosis metastatic germ cell tumour according to the IGCCCG criteria entered this study. Pts consented to receive four 14-day (d) cycles of cisplatin (P) (50mg/m2, d1-2), etoposide (E) (165mg/m2, d1-3), bleomycin (B) (30,000IU, 3 doses/cycle at 4-6 d intervals) and G-CSF (PEG-filgrastin 6mg sc, d4), for a planned relative dose density of 1.5 for each drug compared to standard BEP. Results: 16 pts were recruited from 4 UK centers (2004-2008). 11 pts had intermediate and 5 had poor-prognosis disease. 14/16 pts (87.5%) completed the study treatment as per protocol. In these 14 pts the mean relative dose density achieved of P was 1.5 (range,1.3-1.6), ...