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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.
Berthold, Frank; Ernst, Angela; Hero, Barbara; Klingebiel, Thomas; Kremens, Bernhard; Schilling, Freimut H; Simon, Thorsten.
Afiliação
  • Berthold F; Children's Hospital, University of Cologne, Cologne, Germany. frank.berthold@uk-koeln.de.
  • Ernst A; Institute of Medical Statistics and Bioinformatics, University of Cologne, Cologne, Germany.
  • Hero B; Children's Hospital, University of Cologne, Cologne, Germany.
  • Klingebiel T; Children's Hospital, University of Frankfurt, Frankfurt, Germany.
  • Kremens B; Children's Hospital, University of Essen, Essen, Germany.
  • Schilling FH; Children's Hospital, Olgahospital, Stuttgart, Germany.
  • Simon T; Children's Hospital, University of Cologne, Cologne, Germany.
Br J Cancer ; 119(3): 282-290, 2018 08.
Article em En | MEDLINE | ID: mdl-29991700
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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transplante Autólogo / Quimioterapia de Manutenção / Recidiva Local de Neoplasia / Neuroblastoma Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Infant / Male País/Região como assunto: Europa Idioma: En Revista: Br J Cancer Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Alemanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transplante Autólogo / Quimioterapia de Manutenção / Recidiva Local de Neoplasia / Neuroblastoma Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Infant / Male País/Região como assunto: Europa Idioma: En Revista: Br J Cancer Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Alemanha