A
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of >1 mm who have undergone complete resection, including total lymphadenectomy
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Adjuvant
- Trial Name
- EORTC 18071
- NCT Number
- NCT00636168
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- 5-years RFS
- Evaluated Outcome
- 5-years DFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 54.40%
- OS Gain
- 11%
- OS HR
- 0.72 (95.1% CI 0.58-0.88)
- RFS HR
- 0.76 (0.64-0.89)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Curative score
-
A
- Comment
-
FDA approval October 2015, not EMA approved
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 76
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 13.01.2023
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.