Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group.

Abstract

PURPOSE:

Patients with localized, grossly resected, or gross residual (orbital only) embryonal rhabdomyosarcoma (ERMS) had 5-year failure-free survival (FFS) rates of 83% and overall survival rates of 95% on Intergroup Rhabdomyosarcoma Study Group (IRSG) protocols III/IV. IRSG D9602 protocol (1997 to 2004) objectives were to decrease toxicity in similar patients by reducing radiotherapy (RT) doses and eliminating cyclophosphamide for the lowest-risk patients.

PATIENTS AND METHODS:

Subgroup A patients (lowest risk, with ERMS, stage 1 group I/IIA, stage 1 group III orbit, stage 2 group I) received vincristine plus dactinomycin (VA). Subgroup B patients (ERMS, stage 1 group IIB/C, stage I group III nonorbit, stage 2 group II, stage 3 group I/II) received VA plus cyclophosphamide. Patients in group II/III received RT. Compared with IRS-IV, doses were reduced from 41.4 to 36 Gy for stage 1 group IIA patients and from 50 or 59 to 45 Gy for group III orbit patients.

RESULTS:

Estimated 5-year FFS rates were 89% (95% CI, 84% to 92%) for subgroup A patients (n = 264) and 85% (95% CI, 74%, 91%) for subgroup B patients (n = 78); median follow-up: 5.1 years. Estimated 5-year FFS rates were 81% (95% CI, 68% to 90%) for patients with stage 1 group IIA tumors (n = 62) and 86% (95% CI, 76% to 92%) for patients with group III orbit tumors (n = 77).

CONCLUSION:

Five-year FFS and OS rates were similar to those observed in comparable IRS-III patients, including patients receiving reduced RT doses, but were lower than in comparable IRS-IV patients receiving VA plus cyclophosphamide. Five-year FFS rates were similar among subgroups A and B patients.

• Authors: R Beverly Raney, David O Walterhouse, Jane L Meza, Richard J Andrassy, John C Breneman, William M Crist, Harold M Maurer, William H Meyer, David M Parham, James R Anderson
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 29 Issue 10 Pg. 1312-8 (Apr 01 2011) ISSN: 1527-7755 [Electronic] United States
• PMID: 21357783 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)

Chemical References

• Dactinomycin
• Vincristine
• Cyclophosphamide

Topics

• Adolescent
• Adult
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Child
• Child, Preschool
• Cyclophosphamide (administration & dosage)
• Dactinomycin (administration & dosage)
• Disease-Free Survival
• Female
• Humans
• Kaplan-Meier Estimate
• Lymphatic Metastasis
• Male
• Neoplasm Recurrence, Local
• Neoplasm Staging
• Proportional Hazards Models
• Radiation Dosage
• Radiotherapy, Adjuvant
• Rhabdomyosarcoma, Embryonal (drug therapy, mortality, radiotherapy, secondary)
• Risk Assessment
• Risk Factors
• Survival Rate
• Time Factors
• Treatment Outcome
• United States
• Vincristine (administration & dosage)
• Young Adult