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 language | English |
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Pages (from-to) | 1152-1159 |
Number of pages | 8 |
Journal | Annals of Oncology |
Volume | 16 |
Issue number | 7 |
DOIs | |
Publication status | Published - Jul 2005 |
Keywords
- CarboPEC
- Germ cell tumours
- High-dose chemotherapy
- Randomised trial
ASJC Scopus subject areas
- Oncology
- Cancer Research