Originally published as JCO Early Release 10.1200/JCO.2009.22.3768 on September 21 2009

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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

From the Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN; Departments of Biostatistics and Epidemiology, Pathology, and Pediatric Hematology/Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Division of Hematology/Oncology, Seattle Children's Hospital, Seattle, WA; Departments of Pediatric Surgery and Pathology, University of Pittsburgh, Pittsburgh, PA; Department of Surgery, M. D. Anderson Cancer Center, Houston, TX; Tampa Children's Hospital, University of South Florida, Tampa, FL; Department of Radiation Oncology, Johns Hopkins Hospital, Baltimore, MD; Division of Radiation Oncology, Cincinnati Children's Medical Center, Cincinnati, OH; Radiation Oncology, Stanford University Medical Center, Stanford, CA; and Preventive and Societal Medicine, University of Nebraska Medical Center, Omaha NE.

Corresponding author: Carola A.S. Arndt, MD, Department of Pediatric and Adolescent Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: carndt{at}mayo.edu.

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 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.

Supported by Grants No. U10 CA98543 and U10 CA98413 from the National Cancer Institute/National Institutes of Health.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL, and presented in part at the 40th Congress of the International Society of Paediatric Oncology, October 2-6, 2008, Berlin, Germany.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00003958 [ClinicalTrials.gov] .

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