789O - The TAXIF II protocol final results: a phase II trial of high-dose chemotherapy supported by haematopoietic stem cell transplantation in patients wi...

Date 30 September 2012
Event ESMO Congress 2012
Session Genitourinary tumors, bladder and testicular cancer
Topics Germ Cell Tumours
Translational Research
Presenter Frédéric Selle
Authors F. Selle1, P. Biron2, G. Gravis3, B. Bui4, J. Bay5, A. Flechon6, C. Dubot7, A. Caty8, D. Burcoveanu1, R. Delva9, T. De Revel10, J.M. Miclea11, M. Gaulet12, E. Horn13, S. Provent1, I. Temby1, I. Brindel11, A. Khalil1, J. Lotz14
  • 1Medical Oncology, Hôpital Tenon, 75020 - Paris/FR
  • 2Centre Léon Bérard, 69008 - Lyon CEDEX/FR
  • 3Service D'oncologie, Institut Paoli Calmettes, 13273 - Marseille/FR
  • 4Medical Oncology, Institute Bergonie, FR-33076 - Bordeaux CEDEX/FR
  • 5Service De Médecine, Centre Hospitalier Universitaire, Clermont-Ferrand/FR
  • 6Medical Oncology, Centre Léon Bérard, 69008 - Lyon CEDEX/FR
  • 7Medical Oncology, APHP, CancerEst, Tenon hospital, 75020 - Paris/FR
  • 8Medical Oncology, Centre Oscar Lambret, Lille/FR
  • 9Dept. Of Medical Oncology, Centre Oscar Lambret, Lille/FR
  • 10Service D’hématologie, Hôpital d’Instruction des Armées Percy, Clamart/FR
  • 11Unité De Cytaphérèse Et Thérapie Cellulaire Et Département De La Recherche Clinique Et Du Développement, Hôpital St-Louis, AP-HP, Paris/FR
  • 123es-cegedim, Strategic Data, Boulogne/FR
  • 13Alpert Medical School, Brown University, Providence/US
  • 14APHP, CancerEst, Tenon hospital, 75020 - Paris/FR

Abstract

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.