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Long-term outcomes of the GPOH NB97 trial for children with high-risk neuroblastoma comparing high-dose chemotherapy with autologous stem cell transplantation and oral chemotherapy as consolidation.
Long-term outcomes of the GPOH NB97 trial for children with high-risk neuroblastoma comparing high-dose chemotherapy with autologous stem cell transplantation and oral chemotherapy as consolidation.
- Source :
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British journal of cancer [Br J Cancer] 2018 Aug; Vol. 119 (3), pp. 282-290. Date of Electronic Publication: 2018 Jul 11. - Publication Year :
- 2018
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Abstract
- Background: This study was done to investigate the long-term event free and overall survival of high-dose chemotherapy followed by autologous stem cell transplantation (ASCT), compared to maintenance chemotherapy (MT). Patterns of recurrences and late sequelae of both arms were analysed.<br />Methods: A randomised open label trial was conducted nationwide during 1997-2004 in Germany and Switzerland. 295 patients with high-risk neuroblastoma were randomly assigned to high-dose chemotherapy with autologous stem cell transplantation (ASCT) or maintenance chemotherapy (MT) for consolidation. Analyses were done by intention-to-treat (ITT: ASCT/MT N = 149/146), as treated (AT: N = 110/102), and treated as randomised (TAR: N = 75/70).<br />Results: The event free survival was superior for the patients receiving ASCT compared to patients treated with MT in all three cohorts (hazard ratio [HR] for ITT 1.39, 95% confidence interval (CI) 1.05-1.85, P = 0.022, HR for AT 1.75, CI 1.24-2.47, P = 0.001; HR for TAR 2.07, CI 1.36-3.16, P = 0.001). Overall survival was also in favour of the ASCT groups (ITT: P = 0.075; AT: P = 0.017; TAR: P = 0.005). The frequencies of late sequelae were not different except for focal nodular hyperplasia of the liver observed more frequently in the ASCT arm.<br />Conclusions: High-dose chemotherapy with autologous stem cell transplantation had a better long-term outcome compared to maintenance chemotherapy.
- Subjects :
- Adolescent
Adult
Child
Child, Preschool
Combined Modality Therapy
Cyclophosphamide administration & dosage
Disease-Free Survival
Female
Germany
Hematopoietic Stem Cell Transplantation methods
Humans
Infant
Male
Neoplasm Recurrence, Local pathology
Neuroblastoma pathology
Switzerland
Treatment Outcome
Young Adult
Maintenance Chemotherapy methods
Neoplasm Recurrence, Local therapy
Neuroblastoma therapy
Transplantation, Autologous
Subjects
Details
- Language :
- English
- ISSN :
- 1532-1827
- Volume :
- 119
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- British journal of cancer
- Publication Type :
- Academic Journal
- Accession number :
- 29991700
- Full Text :
- https://doi.org/10.1038/s41416-018-0169-8