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dc.contributor.authorLorigan, Paul C
dc.contributor.authorVerweij, Jaap
dc.contributor.authorPapai, Zsuzsa
dc.contributor.authorRodenhuis, Sjoerd
dc.contributor.authorLe Cesne, Axel
dc.contributor.authorLeahy, Michael G
dc.contributor.authorRadford, John A
dc.contributor.authorVan Glabbeke, Martine M
dc.contributor.authorKirkpatrick, Anne
dc.contributor.authorHogendoorn, Pancras C W
dc.contributor.authorBlay, Jean-Yves
dc.date.accessioned2009-06-11T11:22:48Z
dc.date.available2009-06-11T11:22:48Z
dc.date.issued2007-07-20
dc.identifier.citationPhase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. 2007, 25 (21):3144-50 J. Clin. Oncol.en
dc.identifier.issn1527-7755
dc.identifier.pmid17634494
dc.identifier.doi10.1200/JCO.2006.09.7717
dc.identifier.urihttp://hdl.handle.net/10541/70176
dc.description.abstractPURPOSE: Single-agent doxorubicin remains the standard treatment for advanced soft tissue sarcomas. Combining doxorubicin with standard-dose ifosfamide has not been shown to improve survival and is associated with a significantly increased toxicity; it is not known whether higher dose single-agent ifosfamide is superior to doxorubicin. PATIENTS AND METHODS: This randomized prospective multicenter phase III trial was designed to compare progression-free survival of patients with advanced soft tissue sarcoma receiving either regimen of standard doxorubicin 75 mg/m2 every 21 days, ifosfamide 9 g/m2 over 3 days continuous infusion, or ifosfamide 3 g/m2 per day in 3 hours over 3 days. The primary end point was progression-free survival. Secondary end points included overall survival, response rate, and toxicity. RESULTS: The study included 326 patients. Grade 4 leukopenia, neutropenia, febrile neutropenia, and encephalopathy were more frequent in the ifosfamide arms. Progression-free survival, overall survival, and response rates were not significantly different between the three arms. An independent data monitoring committee reviewed the interim data and recommended early closure of the trial for futility (ie, no significant difference would be shown). CONCLUSION: Single-agent doxorubicin remains the treatment of choice for patients with advanced soft tissue sarcoma.
dc.language.isoenen
dc.subjectBone Canceren
dc.subjectCancer Stagingen
dc.subjectCancer Invasivenessen
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshBone Neoplasms
dc.subject.meshDose-Response Relationship, Drug
dc.subject.meshDoxorubicin
dc.subject.meshDrug Administration Schedule
dc.subject.meshFemale
dc.subject.meshFollow-Up Studies
dc.subject.meshHumans
dc.subject.meshIfosfamide
dc.subject.meshInfusions, Intravenous
dc.subject.meshMale
dc.subject.meshMaximum Tolerated Dose
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasm Invasiveness
dc.subject.meshNeoplasm Staging
dc.subject.meshProbability
dc.subject.meshProspective Studies
dc.subject.meshRisk Assessment
dc.subject.meshSarcoma
dc.subject.meshSurvival Analysis
dc.subject.meshTreatment Outcome
dc.titlePhase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study.en
dc.typeArticleen
dc.contributor.departmentWeston Park Hospital, Sheffield, United Kingdom. Paul.Lorigan@christie-tr.nwest.nhs.uken
dc.identifier.journalJournal of Clinical Oncologyen
html.description.abstractPURPOSE: Single-agent doxorubicin remains the standard treatment for advanced soft tissue sarcomas. Combining doxorubicin with standard-dose ifosfamide has not been shown to improve survival and is associated with a significantly increased toxicity; it is not known whether higher dose single-agent ifosfamide is superior to doxorubicin. PATIENTS AND METHODS: This randomized prospective multicenter phase III trial was designed to compare progression-free survival of patients with advanced soft tissue sarcoma receiving either regimen of standard doxorubicin 75 mg/m2 every 21 days, ifosfamide 9 g/m2 over 3 days continuous infusion, or ifosfamide 3 g/m2 per day in 3 hours over 3 days. The primary end point was progression-free survival. Secondary end points included overall survival, response rate, and toxicity. RESULTS: The study included 326 patients. Grade 4 leukopenia, neutropenia, febrile neutropenia, and encephalopathy were more frequent in the ifosfamide arms. Progression-free survival, overall survival, and response rates were not significantly different between the three arms. An independent data monitoring committee reviewed the interim data and recommended early closure of the trial for futility (ie, no significant difference would be shown). CONCLUSION: Single-agent doxorubicin remains the treatment of choice for patients with advanced soft tissue sarcoma.


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