Universität zu Köln

Berthold, Frank, Ernst, Angela ORCID: 0000-0003-2375-1889, Hero, Barbara, Klingebiel, Thomas, Kremens, Bernhard, Schilling, Freimut H. and Simon, Thorsten (2018). 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. Br. J. Cancer, 119 (3). S. 282 - 291. LONDON: NATURE PUBLISHING GROUP. ISSN 1532-1827

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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. 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). 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. CONCLUSIONS: High-dose chemotherapy with autologous stem cell transplantation had a better long-term outcome compared to maintenance chemotherapy.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Berthold, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Ernst, Angela UNSPECIFIED orcid.org/0000-0003-2375-1889 UNSPECIFIED Hero, Barbara UNSPECIFIED UNSPECIFIED UNSPECIFIED Klingebiel, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Kremens, Bernhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Schilling, Freimut H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Simon, Thorsten UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-178711
DOI:	10.1038/s41416-018-0169-8
Journal or Publication Title:	Br. J. Cancer
Volume:	119
Number:	3
Page Range:	S. 282 - 291
Date:	2018
Publisher:	NATURE PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1532-1827
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language BONE-MARROW-TRANSPLANTATION; EVENT-FREE SURVIVAL; INDUCTION CHEMOTHERAPY; 13-CIS-RETINOIC ACID; BUSULFAN-MELPHALAN; RANDOMIZED-TRIAL; GRADING SYSTEM; ONCOLOGY-GROUP; RESCUE; STANDARD Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/17871