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Annals of Oncology Advance Access published online on May 31, 2005
Annals of Oncology, doi:10.1093/annonc/mdi228
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© 2005 European Society for Medical Oncology
Received December 2, 2004
Revised March 21, 2005
Accepted March 30, 2005

Original article

A randomised trial of high-dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumours

J.-L. Pico 1, G. Rosti 2, A. Kramar 3*, H. Wandt 4, V. Koza 5, R. Salvioni 6, C. Theodore 1, G. Lelli 7, W. Siegert 8, A. Horwich 9, M. Marangolo 2, W. Linkesch 10, G. Pizzocaro 6, H.-J. Schmoll 11, J. Bouzy 1, J.-P. Droz 12, P. Biron 12, and for the Genito-Urinary Group of the French Federation of Cancer Centers (GETUG-FNCLCC), France and the European Group for Blood and Marrow Transplantation (EBMT)

1 Institut Gustave Roussy, Villejuif, France
2 Ospedale Santa Maria Delle Croci, Ravenna, Italy
3 CRLC Val d'Aurelle, Montpellier, France
4 Klinikum Nord U. Inst. F. Onkologie, Nuremberg, Germany
5 Charles University Hospital, Pilsen, Czech Republic
6 Istituto Nazionale Tumori, Milan, Italy
7 Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Italy
8 Universitatklinikum Rudolf Virchow, Berlin, Germany
9 The Royal Marsden Hospital, London, UK
10 Medizinische Universitatklinik, Graz, Austria
11 Martin Luther Universität, Halle, Germany
12 CAC Léon Bérard, Lyon, France

* To whom correspondence should be addressed.
A. Kramar, E-mail: akramar{at}valdorel.fnclcc.fr


  Abstract

Background: Incomplete remission or relapse from first-line chemotherapy has poor prognosis in male germ cell tumour patients. This phase III randomised trial compares conventional salvage to high-dose-intensification chemotherapy.

Patients and methods: Between February 1994 and September 2001, 280 patients from 43 institutions in 11 countries, were randomly assigned to receive either four cycles of cisplatin, ifosfamide and etoposide (or vinblastine) (arm A), or three such cycles followed by high-dose carboplatin, etoposide and cyclophosphamide (CarboPEC) with haematopoietic stem cell support (arm B).

Results: Similar complete and partial response rates were observed in both treatment arms (56%; 95% CI 50% to 62%). There were 3% and 7% toxic deaths in arms A and B, respectively. No significant improvements with CarboPEC were observed in either 3-year event-free survival (35% versus 42%, P=0.16) or overall survival (53%; 95% CI 46% to 59%). Complete responders with CarboPEC had a significant improvement in disease-free survival (55% versus 75% at 3 years, P <0.04).

Conclusions: The single cycle of high-dose salvage chemotherapy after three cycles of standard dose chemotherapy had no effect on treatment outcomes. These results suggest that data from uncontrolled studies should not be used to justify routine use of a toxic and expensive treatment without confirmation in a randomised trial.

Keywords: CarboPEC; germ cell tumours; high-dose chemotherapy; randomised trial.
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