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.

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/m(2) + thiotepa, 400 mg/m(2), followed by two ICE regimens (ifosfamide, 10 g/m(2), carboplatin, AUC 20, etoposide, 1500 mg/m(2))].

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.

• Authors: J-P Lotz, B Bui, F Gomez, C Théodore, A Caty, K Fizazi, G Gravis, R Delva, J Peny, P Viens, B Duclos, T De Revel, H Curé, J Gligorov, S Guillemaut, C Ségura, S Provent, J-P Droz, S Culine, P Biron, Groupe d'Etudes des Tumeurs Uro-Génitales (GETUG)
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 16 Issue 3 Pg. 411-8 (Mar 2005) ISSN: 0923-7534 [Print] England
• PMID: 15659420 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Epirubicin
• Etoposide
• Carboplatin
• Paclitaxel
• Ifosfamide

Topics

• Adolescent
• Adult
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Carboplatin (administration & dosage)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Epirubicin (administration & dosage)
• Etoposide (administration & dosage)
• Humans
• Ifosfamide (administration & dosage)
• Infusions, Intravenous
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Neoplasms, Germ Cell and Embryonal (drug therapy, pathology)
• Paclitaxel (administration & dosage)
• Prognosis
• Stem Cell Transplantation
• Testicular Neoplasms (drug therapy, pathology)
• Transplantation, Autologous
• Treatment Outcome