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Nonmetastatic Rhabdomyosarcoma in Children and Adolescents: Overall Results of the European Pediatric Soft Tissue Sarcoma Study Group RMS2005 Study
G. Bisogno, V. Minard-Colin, I. Zanetti, A. Ferrari, S. Gallego, R. Dávila Fajardo, H. Mandeville, A. Kelsey, R. Alaggio, D. Orbach, S. Terwisscha van Scheltinga, G. Guillén Burrieza, M. Ben-Arush, H. Glosli, P. Mudry, S. Ferman, C. Devalck, AS....
Language English Country United States
Document type Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't
Grant support
5943
Cancer Research UK - United Kingdom
NLK
Free Medical Journals
from 2004 to 1 year ago
Open Access Digital Library
from 1999-01-01
PubMed
36848614
DOI
10.1200/jco.22.02093
Knihovny.cz E-resources
- MeSH
- Dactinomycin MeSH
- Child MeSH
- Humans MeSH
- Adolescent MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Rhabdomyosarcoma * drug therapy MeSH
- Sarcoma * pathology MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Adolescent MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Research Support, Non-U.S. Gov't MeSH
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The RMS2005 study included two phase III randomized trials for high-risk (HR) and observational trials for low (LR), standard (SR), and very high-risk (VHR) patients who have been partially reported. Herein, we present a comprehensive report of results achieved for the complete unselected nonmetastatic cohort and analyze the evolution of treatment in comparison with previous European protocols. After a median follow-up of 73.1 months, the 5-year event-free survival (EFS) and overall survival (OS) of the 1,733 patients enrolled were 70.7% (95% CI, 68.5 to 72.8) and 80.4% (95% CI, 78.4 to 82.3), respectively. The results by subgroup: LR (80 patients) EFS 93.7% (95% CI, 85.5 to 97.3), OS 96.7% (95% CI, 87.2 to 99.2); SR (652 patients) EFS 77.4% (95% CI, 73.9 to 80.5), OS 90.6% (95% CI, 87.9 to 92.7); HR (851 patients) EFS 67.3% (95% CI, 64.0 to 70.4), OS 76.7% (95% CI, 73.6 to 79.4); and VHR (150 patients) EFS 48.8% (95% CI, 40.4 to 56.7), OS 49.7% (95% CI, 40.8 to 57.9). The RMS2005 study demonstrated that 80% of children with localized rhabdomyosarcoma could be long-term survivors. The study has established the standard of care across the European pediatric Soft tissue sarcoma Study Group countries with the confirmation of a 22-week vincristine/actinomycin D regimen for LR patients, the reduction of the cumulative ifosfamide dose in the SR group, and for HR disease, the omission of doxorubicin and the addition of maintenance chemotherapy.
Department of Paediatric Oncology Children's Hospital for Wales Heath Park Cardiff United Kingdom
Department of Pediatric Oncology and Hematology Hospital Universitari Vall d'Hebron Barcelona Spain
Department of Pediatric Surgery Hospital Universitari Vall d'Hebron Barcelona Spain
Pathology Unit Department of Laboratories Bambino Gesu Children's Hospital IRCCS Rome Italy
Pediatric and AYA Oncology Unit Oscar Lambret Center Lille France
Pediatric Hematology Oncology Division University Hospital of Padua Padua Italy
Pediatric Oncology Department National Cancer Institute Rio de Janeiro Brazil
Pediatric Oncology Unit Fondazione IRCCS Istituto Nazionale Tumori Milano Italy
Princess Máxima Center for Pediatric Oncology Utrecht the Netherlands
Radiation Oncology University Medical Center Utrecht Utrecht the Netherlands
SIREDO Oncology Center Institut Curie PSL University Paris France
References provided by Crossref.org
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