title: 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: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.affiliation: Children's Cancer Hospital, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: R Beverly
authors.initials: RB
authors.lastname: Raney
authors.forename: David O
authors.initials: DO
authors.lastname: Walterhouse
authors.forename: Jane L
authors.initials: JL
authors.lastname: Meza
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Andrassy
authors.forename: John C
authors.initials: JC
authors.lastname: Breneman
authors.forename: William M
authors.initials: WM
authors.lastname: Crist
authors.forename: Harold M
authors.initials: HM
authors.lastname: Maurer
authors.forename: William H
authors.initials: WH
authors.lastname: Meyer
authors.forename: David M
authors.initials: DM
authors.lastname: Parham
authors.forename: James R
authors.initials: JR
authors.lastname: Anderson
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003520:Cyclophosphamide / Q000008:administration & dosage; D003609:Dactinomycin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008207:Lymphatic Metastasis; D008297:Male; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011829:Radiation Dosage; D018714:Radiotherapy, Adjuvant; D018233:Rhabdomyosarcoma, Embryonal / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D018570:Risk Assessment; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014750:Vincristine / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D003609:Dactinomycin; D014750:Vincristine; D003520:Cyclophosphamide