Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Pico, JL; Rosti, G; Kramar, A; Wandt, H; Koza, V; Salvioni, R; Theodore, C; Lelli, G; Siegert, W; Horwich, A; Marangolo, M; Linkesch, W; Pizzocaro, G; Schmoll, HJ; Bouzy, J; Droz, JP; Biron, P; Genito-Urinary Group of the French Federation of Cancer Centers (GETUG-FNCLCC), France; European Group for Blood and Marrow Transplantation (EBMT).
A randomised trial of high-dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumours.
Ann Oncol. 2005; 16(7):1152-1159
Doi: 10.1093/annonc/mdi228
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- Co-Autor*innen der Med Uni Graz
- Linkesch Werner
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use
- Carboplatin - administration & dosage
- Cisplatin - administration & dosage
- Cyclophosphamide - administration & dosage
- Dose-Response Relationship, Drug -
- Etoposide - administration & dosage
- Humans -
- Ifosfamide - administration & dosage
- Male -
- Middle Aged -
- Neoplasms, Germ Cell and Embryonal - drug therapy
- Salvage Therapy -
- Treatment Outcome -
- Vinblastine - administration & dosage
- Find related publications in this database (Keywords)
- CarboPEC
- germ cell tumours
- high-dose chemotherapy
- randomised trial