FINAL OUTCOME EURO EWING 2012

1. EURO EWING 2012
International Randomised Controlled Trial for the Treatment of Newly Diagnosed
Sarcoma Family of Tumours (ESFT)
Version 5.0
2nd June 2017
R1- 600
R2- 750
Dr. Deepak Garg
Orthopedic oncology

2. Aim
Establish a standard regimen of chemotherapy of ESFT
Add on treatment with Zoledronic acid is beneficial or not

3. R1 R2
Inclusio
n
Criteria
- Newly diagnosed ESFT or
Round cell tumor (negative for
EWSR1 gene rearrangement )
- Age > 2Y/ < 50Y
- Randomisation ≤ 45 days after
Dx
- Pt fit for Sx
- No prior Rx other than Sx
- Age > 5Y
- Localised tumor
OR
- Metastatic disease/ Nodal Mets
only at Dx and at least partial
response
- Consolidation chemotherapy as
per protocol
- Medically fit to receive Zoledronic
Exclusio
n
Criteria
- C/I to Rx in R1
- Second malignancy
- Pregnant/breast feeding women
- Dental Sx 6 M prior or planned Sx
6 m after
- H/o jaw fracture
- Ewing tumor of maxilla/ mandible
- Progression of 1’ tumor/
appearance of new lesion
Key Eligibility Criteria

4. Duration
Anticipated accrual time for different randomisations:
Randomisation R1: 5 years
Randomisation R2: 5 years
After treatment, patients will be followed up with clinical
evaluation and scanning for 5 years, or until disease
progression or death if sooner. Patients will be followed up for
progression and death until all trial objectives have been met

5. ARM A (VIDE strategy): VIDE induction; VAI/VAC consolidation
VIDE
6 Cycles
Each cycle 21±3 days +
Hematological recovery
Surgery
Just after hematological recovery
(ANC ≥1.0x109
/L, platelets ≥80x109
/L)
Induction chemotherapy

6. ARM A (VIDE strategy): VIDE induction; VAI/VAC consolidation
Localised disease
Good risk
Localised disease
Poor risk
Metastatic disease
at presentation
1 cycle VAI +
7 cycles VAC
21±3 days I
1 cycle VAI +
1 cycle BuMel
8 cycles VAI
± lung RT
±Z ±Z ±Z
Consolidation chemotherapy
No RT until 10 weeks after BuMelRT concurrently RT concurrently

7. Zoledronic acid
9 cycles
At 28±3 days interval
1st dose at least 24 hour before/ 12 hour after start of 2nd cycle of
consolidation chemotherapy

8. VAC-IE
9 cycles
Alternating VAC and IE
14±3 days interval +
haematological recovery
Surgery
Arm B (VDC/IE strategy): VDC/IE induction; IE/VC consolidation
Induction chemotherapy

9. Localised disease
Good risk/ metastatic
Localised disease
Poor risk
1 cycle VAI +
1 cycle BuMel
±Z
±Z
Consolidation chemotherapy
Arm B (VDC/IE strategy): VDC/IE induction; IE/VC consolidation
5 cycles
Alternating IE and VC
14±3 days interval +
haematological recovery±
Lung RT

10. Zoledronic acid
9 cycles
At 28±3 days interval
1st dose at least 24 hour before/ 12 hour after start of 2nd cycle of
consolidation chemotherapy

11. Good risk/ poor risk ?
The definition localised poor risk and good risk is based on the presence or absence of a
combination of factors:
- Resection at diagnosis
- Tumor volume ≥ 200 ml
- Pre-op RT
- Histological response ≥ 10 % viable cells
- Unresectable tumor treated with RT alone
- Volume < 200ml with poor radiological response
Tumor volume = axbxcxF
F=0.52 for spherical
F= 0.785 for cylindrical

13. Outcome measures
EFS
OS
Adverse events and toxicity
Histology response
Achievement of local control at the end of treatment
Growth parameters and jaw necrosis

14. CONCLUSION
VAC/IE offers better EFS and OS than VIDE
May 29th, 2020
ASCO annual meet

15. VAC/IE VIDE
HR
Favouring
VAC/IE
3Y EFS 69% 58% 0.66
3Y OS 82% 74% 0.64
May 29th, 2020
ASCO annual meet

16. EFS OS
May 29th, 2020
ASCO annual meet

17. “The EURO EWING trial has demonstrated, with a hig
of certainty, that EFS and OS are better in 2012 usin
IE,” Dr. Brennan said.
May 29th, 2020
ASCO annual meet

18. Thank You