OnCo
trialsTrialPositive

INT-0091 (Ewing sarcoma)

Adding ifosfamide and etoposide improved cure rates for localised Ewing sarcoma, setting the backbone still used today.

Non-metastatic patients: 5-year EFS 69% vs 54% (NEJM 2003); no benefit in metastatic disease. Foundation of VDC/IE; interval compression (AEWS0031) later improved it further.

Setting
Newly diagnosed Ewing sarcoma: VDC alone vs VDC alternating with ifosfamide-etoposide
Phase
Phase 3
Sponsor
Children's Cancer Group / POG
Registry
Headline result
5-year EFS 69% vs 54% (localised).
Reported
2003
Enrolled
518

Outcomes

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In plain words
What these results mean for people, not percentages
518 people took part
Event-free survival at 5 years (localised)primarysurrogate endpoint
  • 69 vs 54 out of 100 free of a major event at 5 years with VDC/IE compared with VDC; 15 more per 100.
  • Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • The p-value (0.005) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Newly diagnosed Ewing sarcoma: VDC alone vs VDC alternating with ifosfamide-etoposide. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

518 participants enrolled.

Event-free survival at 5 years (localised)primary
· p = 0.005
VDC/IE69 of 100
n = 198
VDC54 of 100
n = 200
Source
EndpointArmnValueHR (95% CI)pSource
Event-free survival at 5 years (localised)primaryVDC/IE19869%0.005link
VDC20054%

Connected

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