1
Indication details
- Combined Agent(s)
- Paclitaxel + carboplatin
- Control Arm
- Paclitaxel + carboplatin
- Therapeutic Indication
- In combination with carboplatin and paclitaxel for the front-line treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Ovarian Cancer
- Tumour Stage
- Advanced
- Trial Name
- ICON7
- NCT Number
- NCT00483782
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2018
- EMA Approval
- EMA (CHMP) September 2011 EC decision November 2011
- Comment
- EMA and FDA approvals are limited to patients with high risk for progression. This is supported by an exploratory subgroup analysis that is not eligible for ESMO-MCBS scoring (median OS control 30.2 months; median OS gain 9.5 months; HR OS 0.78 (95% CI 0.63-0.97).
Primary Outcome(s)
- Primary Outcome(s)
- PFS stratified for stage and risk of progression (All)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 17.4 months
- PFS Gain
- 2.4 months
- PFS HR
- 0.87 (0.77-0.99)
- OS Control
- 58.6 months
- OS Gain
- negative 0.6 months
- OS HR
- 0.99 (0.85-1.14) mature, NS, (data cut-off March 31, 2013)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
>10% incremental discontinuation due to AEs
Score (after adjustments)
- Preliminary non-curative score
-
1
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 38
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 21.11.2024
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.