Vincristine, Actinomycin, and Cyclophosphamide Compared With Vincristine, Actinomycin, and Cyclophosphamide Alternating With Vincristine, Topotecan, and Cyclophosphamide for Intermediate-Risk Rhabdomyosarcoma: Children's Oncology Group Study D9803

Authors:
  • JSJulie A. Stoner
    Julie A. Stoner
  • DHDouglas S. Hawkins
    Douglas S. Hawkins
  • DRDavid A. Rodeberg
    David A. Rodeberg
  • AHAndrea A. Hayes-Jordan
    Andrea A. Hayes-Jordan
  • CPCharles N. Paidas
    Charles N. Paidas
  • DPDavid M. Parham
    David M. Parham
  • LTLisa A. Teot
    Lisa A. Teot
  • MWMoody D. Wharam
    Moody D. Wharam
  • JBJohn C. Breneman
    John C. Breneman
  • SDSarah S. Donaldson
    Sarah S. Donaldson
  • JAJames R. Anderson
    James R. Anderson
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Abstract
Purpose: The purpose of this study was to compare the outcome of patients with intermediate-risk rhabdomyosarcoma (RMS) treated with standard VAC (vincristine, dactinomycin, and cyclophosphamide) chemotherapy to that of patients treated with VAC alternating with vincristine, topotecan, and cyclophosphamide (VAC/VTC).Patients and Methods: Patients were randomly assigned to 39 weeks of VAC versus VAC/VTC; local therapy began after week 12. Patients with parameningeal RMS with intracranial extension (PME) were treated with VAC and immediate x-ray therapy. The primary study end point was failure-free survival (FFS). The study was designed with 80% power (5% two-sided α level) to detect an increase in 5-year FFS from 64% to 75% with VAC/VTC.Results: A total of 617 eligible patients were entered onto the study: 264 were randomly assigned to VAC and 252 to VAC/VTC; 101 PME patients were nonrandomly treated with VAC. Treatment strata were embryonal RMS, stage 2/3, group III (33%); embryonal RMS, group IV, less than age 10 years (7%); alveolar RMS or undifferentiated sarcoma (UDS), stage 1 or group I (17%); alveolar RMS/UDS (27%); and PME (16%). At a median follow-up of 4.3 years, 4-year FFS was 73% with VAC and 68% with VAC/VTC (P = .3). There was no difference in effect of VAC versus VAC/VTC across risk groups. The frequency of second malignancies was similar between the two treatment groups.Conclusion: For intermediate-risk RMS, VAC/VTC does not significantly improve FFS compared with VAC.

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