A
Indication details
- Control Arm
- Imatinib 1-year
- FDA Therapeutic Indication
- Adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
- Tumour Type
-
Sarcoma
- Tumour Sub-type
- GIST
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- KIT+
- Trial Name
- SSG XVIII
- NCT Number
- NCT00103168
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) May 2013 EC decision July 2013
Primary Outcome(s)
- Primary Outcome(s)
- 5-years RFS
- Evaluated Outcome
- RFS
- Form(s)
- Form 1
Outcome Data
- RFS Control
- 52%
- RFS Gain
- 19%
- RFS HR
- 0.60 (0.44-0.81)
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
- 205
- Scorecard version
- 1
- Issue date
- 21.07.2020
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.