2
Indication details
- Control Arm
- Dacarbazine
- Therapeutic Indication
- Treatment for patients with advanced soft-issue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients
- Tumour Type
-
Sarcoma
- Tumour Sub-type
- Soft tissue - Liposarcoma or leiomyosarcoma
- Tumour Stage
- Advanced
- NCT Number
- NCT01343277
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- OS/PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 1.5 months
- PFS Gain
- 2.7 months
- PFS HR
- 0.55 (0.44-0.70)
- OS Control
- 13.1 months
- OS Gain
- 0.6 months
- OS HR
- Not significant
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
2.3 % treatment-related deaths
Score (after adjustments)
- Preliminary non-curative score
-
3
- Toxicity adjustment
- 1-
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 244
- Scorecard version
- 1
- Issue date
- 08.03.2021
- Last update
- 20.05.2021
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.