Intergroup rhabdomyosarcoma study-IV: results for patients with nonmetastatic disease
N = 883
- Population
- 883 previously untreated eligible patients with nonmetastatic rhabdomyosarcoma
- Design
- 883 previously untreated eligible patients with nonmetastatic rhabdomyosarcoma (1991 to 1997) randomised after surgery by primary tumour site, group and stage. Most were randomised to vincristine and dactinomycin with cyclophosphamide (VAC, n=235), with ifosfamide (VAI, n=222), or vincristine, ifosfamide and etoposide (VIE, n=236); patients with group 3 tumours were also randomised to conventional versus hyperfractionated radiotherapy.
- Arms
- VAC (control, n = 235): Vincristine, dactinomycin and cyclophosphamide, with surgery and (by group) radiotherapy
- VAI (experimental, n = 222): Vincristine, dactinomycin and ifosfamide, with surgery and (by group) radiotherapy
- VIE (experimental, n = 236): Vincristine, ifosfamide and etoposide, with surgery and (by group) radiotherapy
- People
- Crist WM, Intergroup Rhabdomyosarcoma Study Group (IRSG)
Δ 36-month FFS+2 points
Show the numbers
| Endpoint | Analysis | VAI / VIE | VAC | Effect |
|---|---|---|---|---|
| FFSPatients randomised to VAC, VAI or VIE | finalCrist 2001 | 77% at 3 y | 75% at 3 y | P=0.42Overall 3-year failure-free survival was 77% and survival 86% for the 883 patients. Hyperfractionated versus conventional radiotherapy: no significant difference (P = 0.85 for FFS and 0.90 for survival, as printed). |
| Endpoint | Analysis | VAI / VIE | VAC | Effect |
|---|---|---|---|---|
| FFSPatients randomised to VAC, VAI or VIE | finalCrist 2001 | 77% at 3 y | 75% at 3 y | P=0.42Overall 3-year failure-free survival was 77% and survival 86% for the 883 patients. Hyperfractionated versus conventional radiotherapy: no significant difference (P = 0.85 for FFS and 0.90 for survival, as printed). |