AEWS0031
Randomized controlled trial of interval-compressed chemotherapy for the treatment of localized Ewing sarcoma: a report from the Children's Oncology Group
Phase 3N = 587NCT00006734
- Population
- Patients younger than 50 years with newly diagnosed localized extradural Ewing sarcoma; 568 eligible
- Design
- Randomised comparison of the same chemotherapy (vincristine, doxorubicin, cyclophosphamide alternating with ifosfamide and etoposide, 14 cycles, filgrastim between cycles) started every 21 days (standard) or every 14 days (intensified); local therapy from week 13. 587 enrolled and randomised, 568 eligible (284 per arm). Cash 2023 updated outcomes after excluding one patient.
- Primary endpoint
- EFS
- Arms
- Standard timing (every 21 days) (control, n = 284): Vincristine, doxorubicin and cyclophosphamide alternating with ifosfamide and etoposide, cycles every 21 days
- Interval-compressed (every 14 days) (experimental, n = 284): The same chemotherapy with cycles every 14 days
- People
- Womer RB, Children's Oncology Group
EFSHR 0.74 (95% CI 0.54–0.99)Δ 60-month EFS+8 pointsΔ 120-month EFS+9 pointsΔ 120-month OS+7 points
Show the numbers
| Endpoint | Analysis | Interval-compressed (every 14 days) | Standard timing (every 21 days) | Effect |
|---|---|---|---|---|
| EFSEligible patients (568) | primarymedian follow-up 61 monthsWomer 2012 | 73% at 5 y | 65% at 5 y | HR 0.74 (95% CI 0.54–0.99)P=.0485-year EFS (abstract: 'at a median of 5 years'; full text: 'At 5 years'); median follow-up 61 months (range 7-94) for patients without an event. HR for the intensified (14-day) regimen as reported in the full text; the paper does not name the reference group in that sentence, so the direction (intensified vs standard) is read from the figure legend. |
| EFSEligible patients after excluding one patient for diagnostic uncertainty | long term-updateCash 2023 | 70% at 10 y | 61% at 10 y | P=.03 |
| OSEligible patients after excluding one patient for diagnostic uncertainty | long term-updateCash 2023 | 76% at 10 y | 69% at 10 y | P=.04 |
| Endpoint | Analysis | Interval-compressed (every 14 days) | Standard timing (every 21 days) | Effect |
|---|---|---|---|---|
| EFSEligible patients (568) | primarymedian follow-up 61 monthsWomer 2012 | 73% at 5 y | 65% at 5 y | HR 0.74 (95% CI 0.54–0.99)P=.0485-year EFS (abstract: 'at a median of 5 years'; full text: 'At 5 years'); median follow-up 61 months (range 7-94) for patients without an event. HR for the intensified (14-day) regimen as reported in the full text; the paper does not name the reference group in that sentence, so the direction (intensified vs standard) is read from the figure legend. |
| EFSEligible patients after excluding one patient for diagnostic uncertainty | long term-updateCash 2023 | 70% at 10 y | 61% at 10 y | P=.03 |
| OSEligible patients after excluding one patient for diagnostic uncertainty | long term-updateCash 2023 | 76% at 10 y | 69% at 10 y | P=.04 |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| EFS | 0.74 | 0.54–0.99 |
Appears in
Sources
Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR, Grier HE, et al. Randomized controlled trial of interval-compressed chemotherapy for the treatment of localized Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2012;30(33):4148-54.
Cash T, Krailo MD, Buxton AB, Pawel BR, Healey JH, Binitie O, et al. Long-Term Outcomes in Patients With Localized Ewing Sarcoma Treated With Interval-Compressed Chemotherapy on Children's Oncology Group Study AEWS0031. J Clin Oncol. 2023;41(30):4724-4728.