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, G. Rosti, A. Kramar, H. Wandt, V. Koza, R. Salvioni, C. Theodore, G. Lelli, W. Siegert, A. Horwich, M. Marangolo, W. Linkesch, G. Pizzocaro, H. J. Schmoll, J. Bouzy, J. P. Droz, P. Biron

Research output: Contribution to journalArticle

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

Original languageEnglish
Pages (from-to)1152-1159
Number of pages8
JournalAnnals of Oncology
Volume16
Issue number7
DOIs
Publication statusPublished - Jul 2005

Keywords

  • CarboPEC
  • Germ cell tumours
  • High-dose chemotherapy
  • Randomised trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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