INT-0091
Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone
N = 518
- Population
- Patients aged 30 years or younger with Ewing's sarcoma, primitive neuroectodermal tumor of bone or primitive sarcoma of bone; 518 eligible
- Design
- Randomised comparison of 49 weeks of standard chemotherapy (doxorubicin, vincristine, cyclophosphamide, dactinomycin) with the same four drugs alternating with courses of ifosfamide and etoposide. 518 eligible patients in two strata reported separately: nonmetastatic (n=398; 200 standard, 198 experimental) and metastatic (n=120; 62 standard, 58 experimental). Randomisation period 1988-1992 according to a later Children's Oncology Group report on this protocol.
- Arms
- Standard four-drug chemotherapy (control): 49 weeks of doxorubicin, vincristine, cyclophosphamide and dactinomycin
- Four drugs alternating with ifosfamide and etoposide (experimental): The four standard drugs alternating with courses of ifosfamide and etoposide
- People
- Grier HE, Children's Oncology Group
Δ 60-month EFS+15 pointsΔ OS+11 points
Show the numbers
| Endpoint | Analysis | Four drugs alternating with ifosfamide and etoposide | Standard four-drug chemotherapy | Effect |
|---|---|---|---|---|
| EFSNonmetastatic stratum (n=398; 200 standard, 198 experimental) | primaryGrier 2003 | 69% at 5 y | 54% at 5 y | P=0.005Five-year event-free survival as mean +/- standard error: 54+/-4% (standard) vs 69+/-3% (experimental); the abstract gives no confidence intervals or hazard ratio. |
| OSNonmetastatic stratum (n=398; 200 standard, 198 experimental) | primaryGrier 2003 | 72% | 61% | P=0.01Overall survival as mean +/- standard error: 61+/-3.6% (standard) vs 72+/-3.4% (experimental). The abstract does not state the time point. |
| Endpoint | Analysis | Four drugs alternating with ifosfamide and etoposide | Standard four-drug chemotherapy | Effect |
|---|---|---|---|---|
| EFSNonmetastatic stratum (n=398; 200 standard, 198 experimental) | primaryGrier 2003 | 69% at 5 y | 54% at 5 y | P=0.005Five-year event-free survival as mean +/- standard error: 54+/-4% (standard) vs 69+/-3% (experimental); the abstract gives no confidence intervals or hazard ratio. |
| OSNonmetastatic stratum (n=398; 200 standard, 198 experimental) | primaryGrier 2003 | 72% | 61% | P=0.01Overall survival as mean +/- standard error: 61+/-3.6% (standard) vs 72+/-3.4% (experimental). The abstract does not state the time point. |