Phase 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.
AuthorsLorigan, Paul C
Le Cesne, Axel
Leahy, Michael G
Radford, John A
Van Glabbeke, Martine M
Hogendoorn, Pancras C W
AffiliationWeston Park Hospital, Sheffield, United Kingdom. Paul.Lorigan@christie-tr.nwest.nhs.uk
MetadataShow full item record
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.
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.
JournalJournal of Clinical Oncology
- Efficacy of sequential high-dose doxorubicin and ifosfamide compared with standard-dose doxorubicin in patients with advanced soft tissue sarcoma: an open-label randomized phase II study of the Spanish group for research on sarcomas.
- Authors: Maurel J, López-Pousa A, de Las Peñas R, Fra J, Martín J, Cruz J, Casado A, Poveda A, Martínez-Trufero J, Balañá C, Gómez MA, Cubedo R, Gallego O, Rubio-Viqueira B, Rubió J, Andrés R, Sevilla I, de la Cruz JJ, Del Muro XG, Buesa JM
- Issue date: 2009 Apr 10
- Sequential dose-dense doxorubicin and ifosfamide for advanced soft tissue sarcomas: a Phase II trial by the Spanish Group for Research on Sarcomas (GEIS).
- Authors: Maurel J, Fra J, López-Pousa A, García del Muro X, Balañá C, Casado A, Martín J, Martínez-Trufero J, de las Peñas R, Buesa JM, Spanish Group for Research on Sarcomas (GEIS).
- Issue date: 2004 Apr 1
- Phase 1 European Organisation for Research and Treatment of Cancer study determining safety of pegylated liposomal doxorubicin (Caelyx) in combination with ifosfamide in previously untreated adult patients with advanced or metastatic soft tissue sarcomas.
- Authors: Nielsen OS, Reichardt P, Christensen TB, Pink D, Daugaard S, Hermans C, Marreaud S, van Glabbeke M, Blay J, Judson I
- Issue date: 2006 Sep
- Ifosfamide in the treatment of soft-tissue sarcomas: experience at the West German Tumor Center, Essen.
- Authors: Schütte J, Kellner R, Seeber S
- Issue date: 1993
- High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas.
- Authors: Yalcin B, Pamir A, Buyukcelik A, Utkan G, Akbulut H, Demirkazik A, Icli F
- Issue date: 2004 Dec