Superior survival after sequential high-dose chemotherapy (HDCT) as compared to single HDCT in patients with relapsed or refractory germ cell tumors (GCT): Six-year long-term follow-up of a prospective, randomized phase II trial.

4507 Background: Sequential and single high-dose chemotherapy (HDCT) can both be curative in patients (pts) with relapsed or refractory germ-cell tumors (GCT). The long-term efficacy of either modality is unknown. Methods: Between 11/99 and 11/04, 211 pts with relapsed or refractory GTC were prospectively randomized to treatment with either one cycle of cisplatin 100 mg/m², etoposide 375 mg/m² and ifosfamide 6 g/m² (VIP) plus three cycles of high-dose carboplatin 1,500 mg/m² and etoposide 1,500 mg/m² (CE, arm A) or three cycles of VIP plus one cycle of high-dose carboplatin 2,200 mg/m², etoposide 1,800 mg/m² and cyclophosphamide 6,400 mg/m² (CEC, arm B) followed by stem cell reinfusion (JCO 2007,25:2778). Five pts were excluded from further analysis due to non-GCT histologies at review. We evaluated long-term progression-free (PFS) and overall survival (OS) six years after randomization of the last patient. Survival probabilities were compared using the logrank test. Results: Overall, 108 and 103 pts were...