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Tytuł:
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Results of the EICESS-92 Study: two randomized trials of Ewing's sarcoma treatment--cyclophosphamide compared with ifosfamide in standard-risk patients and assessment of benefit of etoposide added to standard treatment in high-risk patients.
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Autorzy:
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Paulussen M; Department of PaediatricHaematology/Oncology, University Children's Hospital Münster, Switzerland. />Craft AW
Lewis I
Hackshaw A
Douglas C
Dunst J
Schuck A
Winkelmann W
Köhler G
Poremba C
Zoubek A
Ladenstein R
van den Berg H
Hunold A
Cassoni A
Spooner D
Grimer R
Whelan J
McTiernan A
Jürgens H
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Corporate Authors:
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European Intergroup Cooperative Ewing's Sarcoma Study-92
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Źródło:
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Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2008 Sep 20; Vol. 26 (27), pp. 4385-93.
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Typ publikacji:
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Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology
Original Publication: New York, N.Y. : Grune & Stratton, c1983-
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MeSH Terms:
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Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
Bone Neoplasms/*drug therapy
Etoposide/*administration & dosage
Ifosfamide/*administration & dosage
Sarcoma, Ewing/*drug therapy
Adolescent ; Adult ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bone Neoplasms/pathology ; Child ; Child, Preschool ; Combined Modality Therapy ; Dactinomycin/administration & dosage ; Disease-Free Survival ; Doxorubicin/administration & dosage ; Female ; Follow-Up Studies ; Hematologic Diseases/chemically induced ; Humans ; Infant ; Lung Neoplasms/secondary ; Male ; Neoplasm Staging ; Prospective Studies ; Sarcoma, Ewing/pathology ; Sarcoma, Ewing/secondary ; Vincristine/administration & dosage
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Substance Nomenclature:
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1CC1JFE158 (Dactinomycin)
5J49Q6B70F (Vincristine)
6PLQ3CP4P3 (Etoposide)
80168379AG (Doxorubicin)
UM20QQM95Y (Ifosfamide)
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SCR Protocol:
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VAIA protocol
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Entry Date(s):
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Date Created: 20080920 Date Completed: 20081009 Latest Revision: 20220316
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Update Code:
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20240104
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DOI:
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10.1200/JCO.2008.16.5720
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PMID:
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18802150
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Purpose: The European Intergroup Cooperative Ewing's Sarcoma Study investigated whether cyclophosphamide has a similar efficacy as ifosfamide in standard-risk (SR) patients and whether the addition of etoposide improves survival in high-risk (HR) patients.
Patients and Methods: SR patients (localized tumors, volume <100 mL) were randomly assigned to receive four courses of vincristine, dactinomycin, ifosfamide, and doxorubicin (VAIA) induction therapy followed by 10 courses of either VAIA or vincristine, dactinomycin, cyclophosphamide, and doxorubicin (VACA; cyclophosphamide replacing ifosfamide). HR patients (volume >or=100 mL or metastases) were randomly assigned to receive 14 courses of either VAIA or VAIA plus etoposide (EVAIA). Outcome measures were event-free survival (EFS; defined as the time to first recurrence, progression, second malignancy, or death) and overall survival (OS).
Results: A total of 647 patients were randomly assigned: 79 SR patients were assigned to VAIA, 76 SR patients were assigned to VACA, 240 HR were assigned to VAIA, and 252 HR patients were assigned to EVAIA. The median follow-up was 8.5 years. In the SR group, the hazard ratios (VACA v VAIA) for EFS and OS were 0.91 (95% CI, 0.55 to 1.53) and 1.08 (95% CI, 0.58 to 2.03), respectively. There was a higher incidence of hematologic toxicities in the VACA arm. In the HR group, the EFS and OS hazard ratios (EVAIA v VAIA) indicated a 17% reduction in the risk of an event (95% CI, -35% to 5%; P = .12) and 15% reduction in dying (95% CI, -34% to 10%), respectively. The effect seemed greater among patients without metastases (hazard ratio = 0.79; P = .16) than among those with metastases (hazard ratio = 0.96; P = .84).
Conclusion: Cyclophosphamide seemed to have a similar effect on EFS and OS as ifosfamide in SR patients but was associated with increased toxicity. In HR patients, the addition of etoposide seemed to be beneficial.
Comment in: Nat Rev Clin Oncol. 2009 May;6(5):251-3. (PMID: 19390548)
