1
Indication details
- Combined Agent(s)
- Chemotherapy
- Control Arm
- Platinum-based chemotherapy + placebo and placebo maintenance
- FDA Therapeutic Indication
- Platinum-sensitive relapsed ovarian cancer
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Ovarian Cancer
- Tumour Stage
- Metastatic
- Trial Name
- ICON 6
- NCT Number
- NCT00532194
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 8.7 months
- PFS Gain
- 2.3 months
- PFS HR
- 0.56 (0.44-0.72)
- OS HR
- NS
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
25-35% discontinuation B/C toxicity >5% increase grade 3/4 fatigue
Score (after adjustments)
- Preliminary non-curative score
-
2
- Toxicity adjustment
- 1-
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 48
- 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.