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High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008
U. Dirksen, B. Brennan, MC. Le Deley, N. Cozic, H. van den Berg, V. Bhadri, B. Brichard, L. Claude, A. Craft, S. Amler, N. Gaspar, H. Gelderblom, R. Goldsby, R. Gorlick, HE. Grier, JM. Guinbretiere, P. Hauser, L. Hjorth, K. Janeway, H. Juergens,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, Research Support, N.I.H., Extramural, práce podpořená grantem
Grantová podpora
U10 CA098413
NCI NIH HHS - United States
U10 CA098543
NCI NIH HHS - United States
U10 CA180886
NCI NIH HHS - United States
U10 CA180899
NCI NIH HHS - United States
Odkazy
PubMed
31553693
DOI
10.1200/jco.19.00915
Knihovny.cz E-zdroje
- MeSH
- adjuvantní radioterapie MeSH
- autologní transplantace MeSH
- časové faktory MeSH
- dítě MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- Ewingův sarkom mortalita sekundární terapie MeSH
- hodnocení rizik MeSH
- kojenec MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru MeSH
- mladiství MeSH
- mladý dospělý MeSH
- nádory kostí mortalita patologie terapie MeSH
- nádory plic mortalita sekundární terapie MeSH
- neoadjuvantní terapie * škodlivé účinky mortalita MeSH
- pneumektomie MeSH
- předškolní dítě MeSH
- progrese nemoci MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- rizikové faktory MeSH
- transplantace hematopoetických kmenových buněk * škodlivé účinky mortalita MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- kojenec MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Research Support, N.I.H., Extramural MeSH
- srovnávací studie MeSH
- Geografické názvy
- Evropa MeSH
PURPOSE: The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases. METHODS: From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and P value were corrected for the three previous interim analyses by the inverse normal method. RESULTS: Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44; P = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm. CONCLUSION: In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.
Birmingham Women and Children's Hospital Birmingham United Kingdom
Centre Hospitalier Universitaire Tours France
Centre Oscar Lambret Lille France
Charles University Prague Czech Republic
Children's Hospital of Philadelphia and University of Pennsylvania Philadelphia PA
Chris O'Brien Lifehouse Camperdown NSW Australia
Cliniques Universitaires Saint Luc Brussels Belgium
Dana Farber Boston Children's Cancer and Blood Disorder Center Boston MA
Emma Children Hospital Amsterdam University Medical Centres Amsterdam the Netherlands
Five Time Therapeutics South San Francisco CA
Friedrich Loeffler Institute Greifswald Insel Riems Germany
Gustave Roussy Université Paris Saclay Villejuif France
Gustave Roussy Villejuif France
Hôpital René Huguenin Saint Cloud France
Institute of Pediatric Onco Haematology Lyon France
Leiden University Medical Center Leiden the Netherlands
MD Anderson Cancer Center Houston TX
Medical University of Vienna Vienna Austria
Nationwide Children's Hospital and The Ohio State University College of Medicine Columbus OH
Northern Institute for Cancer Research Newcastle Upon Tyne United Kingdom
Royal Manchester Children's Hospital Manchester United Kingdom
Royal Marsden Foundation NHS Trust London United Kingdom
Seattle Children's Hospital Seattle WA
Semmelweis University Budapest Hungary
Universitaetskinderklinik Muenster Muenster Germany
Université Paris Saclay Villejuif France
University Children's Hospital Basel Basel Switzerland
University College Hospital London United Kingdom
University Hospital Essen Essen Germany
University of Birmingham Birmingham United Kingdom
University of California Davis Sacramento CA
University of California San Francisco Benioff Children's Hospital San Francisco CA
University of Leeds Liverpool United Kingdom
University of Southern California Los Angeles CA
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