3
Indication details
- Combined Agent(s)
- Carboplatin + paclitaxel
- Control Arm
- Paclitaxel + carboplatin (6 cycles)
- FDA Therapeutic Indication
- 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
- Metastatic
- Trial Name
- GOG-0218
- NCT Number
- NCT00262847
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2018
- EMA Approval
- EMA (CHMP) September 2011. EC decision November 2011
- Comment
- EMA approval based on ICON7 and GOG-0218; FDA approval based on GOG-0218 [08/03/23]. Mature OS NS but crossover allowed, therefore no downgrade applied despite lack of QoL benefit
Primary Outcome(s)
- Primary Outcome(s)
- PFS (crossover allowed), OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 10.3 months
- PFS Gain
- 3.8 months (bevacizumab continuation)
- PFS HR
- 0.72 (0.63-0.82)
- OS Control
- 41.1 months
- OS Gain
- 2.3 months (bevacizumab continuation)
- OS HR
- 0.96 (0.85-1.09) OS NS (mature)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 41
- 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.