A
Indication details
- Combined Agent(s)
- Cis retinoic acid+GMCSF+IL2
- Control Arm
- Cis retinoic acid
- Therapeutic Indication
- <32 years old with high-risk neuroblastoma after remission and stem cell transplatation
- Tumour Type
-
Central Nervous System Malignancies
- Tumour Sub-type
- Neuro-oncology cancer - Neuroblastoma
- Tumour Stage
- Early
- NCT Number
- NCT00026312
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) March 2017 EC decision May 2017
Primary Outcome(s)
- Primary Outcome(s)
- EFS
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- PFS Control
- 2 years 45%
- PFS Gain
- Gain 20%
- OS Control
- 5-year survival 57%
- OS Gain
- Gain 17%
- OS HR
- 0.58 (0.37-0.91)
Final Score (after adjustments)
- Final curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 96
- Scorecard version
- 1
- Issue date
- 11.12.2018
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.