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Annals of Oncology Advance Access published online on January 19, 2005
Annals of Oncology, doi:10.1093/annonc/mdi087
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© 2005 European Society for Medical Oncology
Received July 14, 2004
Revised October 12, 2004
Accepted October 25, 2004

Original article

Sequential high-dose chemotherapy protocol for relapsed poor prognosis germ cell tumors combining two mobilization and cytoreductive treatments followed by three high-dose chemotherapy regimens supported by autologous stem cell transplantation. Results of the phase II multicentric TAXIF trial

J.-P. Lotz 1*, B. Bui 2, F. Gomez 3, C. Théodore 4, A. Caty 5, K. Fizazi 4, G. Gravis 6, R. Delva 7, J. Peny 8, P. Viens 6, B. Duclos 9, T. De Revel 10, H. Curé 11, J. Gligorov 1, S. Guillemaut 3, C. Ségura 3, S. Provent 1, J.-P. Droz 12, S. Culine 13, P. Biron 12, and On behalf of the Groupe d'Etudes des Tumeurs Uro-Génitales (GETUG), Fédération Nationale des Centres de Lutte Contre le Cancer, 101 rue de Tolbiac, 75 013 Paris, France

1 Departments of Medical Oncology, Hôpital Tenon, Paris, France
2 Institut Bergonié, Bordeaux, France
3 Biostatistical Unit, Centre Léon Bérard, Lyon, France
4 Institut Gustave Roussy, Villejuif, France
5 Centre Oscar Lambret, Lille, France
6 Institut Paoli-Calmette, Marseille, France
7 Centre Paul Papin, Angers, France
8 Centre François Baclesse, Caen, France
9 Centre Paul Strauss, Strasbourg, France
10 Hôpital d'Instruction des Armées, Clamart, France
11 Centre Jean Perrin, Clermont-Ferrand, France
12 Centre Léon Bérard, Lyon, France
13 Centre Val d'Aurelle, Montpellier, France

* To whom correspondence should be addressed.
J.-P. Lotz, E-mail: jean-pierre.lotz{at}tnn.ap-hop-paris.fr


  Abstract

Background: High-dose chemotherapy (HD-CT) is able to circumvent platinum resistance of resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New strategies are needed with new drugs and a sequential approach.

Materials and methods: Patients with relapsed poor-prognosis GCTs were scheduled to receive two cycles combining epirubicin and paclitaxel (Taxol) followed by three consecutive HD-CT supported by stem cell transplantation [one course combining cyclophosphamide, 3 g/m2 + thiotepa, 400 mg/m2, followed by two ICE regimens (ifosfamide, 10 g/m2, carboplatin, AUC 20, etoposide, 1500 mg/m2)].

Results: From March 1998 to September 2001 (median follow-up, 31.8 months), 45 patients (median age, 28 years) were enrolled in this phase II study. Twenty-two patients received the complete course. Twenty-five patients died from progression and five from toxicity. The overall response rate was 37.7%, including an 8.9% complete response rate. The median overall survival was 11.8 months. The 3-year survival and progression-free survival rate was 23.5%. The ‘Beyer’ prognostic score predicted the outcome after HD-CT.

Conclusion: Although our results warrant further studies on HD-CT in relapsed poor prognosis GCTs, patients with a Beyer score >2 did not benefit from this approach and should not be enrolled in HD-CT trials. Better selection criteria have to be fulfilled in forthcoming studies.

Keywords: germ-cell tumors; high-dose chemotherapy.
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