A
Indication details
- Control Arm
- Chemotherapy
- Therapeutic Indication
- Treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection.
- Tumour Type
-
Sarcoma
- Tumour Sub-type
- Bone sarcoma
- Trial Name
- Intergroup study 0133
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) May 2009. EC decision July 2009
Primary Outcome(s)
- Primary Outcome(s)
- EFS, OS
- Evaluated Outcome
- OS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 6-year OS: 70%
- OS Gain
- 6-year OS gain: 8%
- OS HR
- 0.71 (0.52-0.96)
- EFS control
- 6-year EFS: 61%
- EFS gain
- 6-year EFS gain: 6%
- EFS HR
- 0.8 (0.62-1.0) (NS)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 482
- Scorecard version
- 1
- Issue date
- 13.12.2024
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.