Paclitaxel, gemcitabine, oxaliplatin regimen in induction therapy of patients with relapsed and refractory germ cell tumors before high-dose chemotherapy: results of a pilot study

Purpose: to evaluate the efficacy of TGO (paclitaxel, gemcitabine, oxaliplatin) regimen as induction therapy for hematopoietic stem cells mobilization (HSC) before high-dose chemotherapy (HDCT) in patients with recurrent nonsemino-matous germ cell tumors (NSGCT). Patients and methods: the study enrolled patients with relapsed and/or refractory NSGCT after frontline chemotherapy. Modified TGO regimen (paclitaxel 100 mg/m2 on day 1 + gemcitabine 1000 mg/m2 on day 1 + oxaliplatin 130 mg/m2 on day 1, once every 14 days) was administered with filgrastim support 10 mcg/kg subcutaneous from day 8 and until the completion of leukapheresis. Maximum 3 cycles of TGO regimen was administered. After harvesting the required volume of CD34+ cells, HDCT was initiated which consisted of 3 cycles of the CE regimen (carboplatin AUC8 on day 1-3 + etopo-side 400 mg/m2 on day 1-3) with further HSC autologous stem cell transplantation (ASCT). Results: Five patients with NSGCT with poor IGCCCG prognosis according were enrolled. All of them received ifos-famide-containing chemotherapy as initial treatment. The required HSC were collected for three cycles of HDCT in all patients (100%); in four (80%) patients the required number of cells was collected after the 1st cycle of TGO. Four (80%) patients started the HDCT phase, one patient prematurely terminated treatment due to the rapid progression. One patient who received full planned therapy demonstrated complete and durable tumor regression at the time of data analysis (with 37 months follow-up). Conclusions: the TGO regimen can be used to collect PBSC from patients with relapsed and/or refractory NSGCT before HDCT, further study of this approach is required.