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Background High-dose chemotherapy (HDCT) has been shown to circumvent resistance in poor-prognosis germ cell tumors (GCT), mainly for patients whose relapses occur more than 4 weeks after cisplatin-based CT. Patients and methods This multicentric phase II trial was addressed to patients with poor-prognosis non-refractory GCTs. The main objectives were to determine the complete response rate and to monitor treatment-associated toxicities. Patients with adverse prognostic factors failing CT were to receive 2 cycles combining Epirubicin and Paclitaxel (EpiTax), followed by 3 consecutive HDCT [one using a Paclitaxel/Thiotepa association, 2 using the 5-day Ifosfamide-Carboplatine-Etoposide regimen]. Inclusion criteria included seminomatous GCT in relapse after 2 lines of CT, non-seminomatous GCT in relapse after 1 or 2 lines, partial remission after 1 line, primary mediastinal GCT in first relapse. Peripheral blood stem cells were collected after the EpiTax cycles. Results Between 09/2004 and 12/2007, 45 patients were included: 45 received 1 HDCT, 39 two HDCT, 29 patients received the complete protocol. Sixteen patients did not received the entire protocol, 8 (53%) for toxic side effects. Two patients (4.4%) died of toxicities, 17 (37.7%) of disease progression. For a median follow-up time of 26 months (4–51 m), the final overall response rate was 66,7% (CR, 20,6%). The median PFS was 16 months (95%CI, 9-NA) and the median OS was 32 months (95%CI, 32–49). The 2-year PFS was a plateau set up at 50% (95%CI, 32-67%) and the 2-year OS was 71% (95%CI, 52–83%). Conclusion The TAXIF II protocol was highly effective in non-refractory GCT patients failing CT. Disclosure F. Selle: consultancy for roche and Pharmamar. All other authors have declared no conflicts of interest. |
