4
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- EMA: Sunitinib is indicated for the ttreatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. FDA: Sunitinib for the treatment of patients with metastatic and/or unresectable GIST whose disease has progressed despite at least imatinib as prior treatments.
- Tumour Type
-
Sarcoma
- Tumour Sub-type
- GIST
- Tumour Stage
- Advanced
- Trial Name
- A6181004
- NCT Number
- NCT00075218
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval January 2006
- EMA Approval
- EMA (CHMP) January 2007. EC decision March 2007
Primary Outcome(s)
- Primary Outcome(s)
- TTP (Crossover allowed) (Scoring of TTP on the same basis as PFS)
- Evaluated Outcome
- TTP
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 6.0 weeks (i.e. 1.4 months)
- PFS Gain
- 18.1 weeks (i.e. 4.2 months)
- PFS HR
- 0.33 (0.24-0.47)
- OS Control
- Not reached (~36 months)
- OS Gain
- ~36 months
- OS HR
- 0.49 (0.29-0.83)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Early stopping or crossover
- 1+
- Non-curative score
-
4
- Comment
-
TTP control: 6.4 weeks (i.e. 1.5 months) TTP gain: 20.9 weeks (i.e. 4.8 months) TTP HR: 0.33 (0.23-0.47). Form 2a cannot be applied since median OS is not reached in the control arm, consequently, score derived from form 2b criteria with an upgrade for early stopping based on OS advantage detected at interim analysis.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 199
- Scorecard version
- 1
- Issue date
- 21.07.2020
- Last update
- 21.03.2025
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.