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dc.contributor.authorDirksen, U
dc.contributor.authorBrennan, B
dc.contributor.authorLe Deley, M-C
dc.contributor.authorCozic, N
dc.contributor.authorvan den Berg, H
dc.contributor.authorBhadri, V
dc.contributor.authorBrichard, B
dc.contributor.authorClaude, L
dc.contributor.authorCraft, A
dc.contributor.authorAmler, S
dc.contributor.authorGaspar, N
dc.contributor.authorGelderblom, H
dc.contributor.authorGoldsby, R
dc.contributor.authorGorlick, R
dc.contributor.authorGrier, HE
dc.contributor.authorGuinbretiere, J-M
dc.contributor.authorHauser, P
dc.contributor.authorHjorth, L
dc.contributor.authorJaneway, K
dc.contributor.authorJuergens, H
dc.contributor.authorJudson, I
dc.contributor.authorKrailo, M
dc.contributor.authorKruseova, J
dc.contributor.authorKuehne, T
dc.contributor.authorLadenstein, R
dc.contributor.authorLervat, C
dc.contributor.authorLessnick, SL
dc.contributor.authorLewis, I
dc.contributor.authorLinassier, C
dc.contributor.authorMarec-Berard, P
dc.contributor.authorMarina, N
dc.contributor.authorMorland, B
dc.contributor.authorPacquement, H
dc.contributor.authorPaulussen, M
dc.contributor.authorRandall, RL
dc.contributor.authorRanft, A
dc.contributor.authorLe Teuff, G
dc.contributor.authorWheatley, K
dc.contributor.authorWhelan, J
dc.contributor.authorWomer, R
dc.contributor.authorOberlin, O
dc.contributor.authorHawkins, DS
dc.contributor.authorEuro-E.W.I.N.G. 99 and Ewing 2008 Investigators
dc.date.accessioned2019-10-23T10:48:57Z
dc.date.issued2019-12
dc.identifier.citationJournal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019, 37 (34), pp. 3192 - 3202
dc.identifier.issn0732-183X
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3392
dc.identifier.eissn1527-7755
dc.identifier.doi10.1200/jco.19.00915
dc.description.abstractPURPOSE: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.
dc.formatPrint-Electronic
dc.format.extent3192 - 3202
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
dc.subjectEuro-E.W.I.N.G. 99 and Ewing 2008 Investigators
dc.subjectHumans
dc.subjectBone Neoplasms
dc.subjectLung Neoplasms
dc.subjectNeoplasm Recurrence, Local
dc.subjectDisease Progression
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectNeoadjuvant Therapy
dc.subjectRadiotherapy, Adjuvant
dc.subjectPneumonectomy
dc.subjectHematopoietic Stem Cell Transplantation
dc.subjectTransplantation, Autologous
dc.subjectRisk Assessment
dc.subjectRisk Factors
dc.subjectTime Factors
dc.subjectAdolescent
dc.subjectAdult
dc.subjectMiddle Aged
dc.subjectChild
dc.subjectChild, Preschool
dc.subjectInfant
dc.subjectEurope
dc.subjectFemale
dc.subjectMale
dc.subjectYoung Adult
dc.subjectSarcoma, Ewing
dc.subjectProgression-Free Survival
dc.titleHigh-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.
dc.typeJournal Article
rioxxterms.versionofrecord10.1200/jco.19.00915
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
rioxxterms.licenseref.startdate2019-12
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJournal of clinical oncology : official journal of the American Society of Clinical Oncology
pubs.issue34
pubs.notesNo embargo
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials
pubs.publication-statusPublished
pubs.volume37
pubs.embargo.termsNo embargo
icr.researchteamSarcoma Clinical Trialsen_US
dc.contributor.icrauthorJudson, Ianen


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