4
Indication details
- Combined Agent(s)
- Chemotherapy
- Control Arm
- Paclitaxel or topotecan or liposomal doxorubicin
- FDA Therapeutic Indication
- In combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube,or primary peritoneal cancer who received ≤2 prior ChT regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Ovarian Cancer
- Tumour Stage
- Metastatic
- Trial Name
- AURELIA
- NCT Number
- NCT00976911
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) June 2014 EC decision August 2014
Primary Outcome(s)
- Primary Outcome(s)
- PFS (crossover allowed), OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 3.4 months
- PFS Gain
- 3.3 months
- PFS HR
- 0.48 (0.38-0.60)
- OS Control
- 13.3 months
- OS Gain
- 3.3 months
- OS HR
- 0.85 (0.66-1.08) OS NS (mature)
Adjustments
- QoL Comment
-
Improved QoL
- Toxicity Comment
-
>10% incremental discontinuation due to AEs
Score (after adjustments)
- Preliminary non-curative score
-
3
- QoL adjustment
- 1+
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 37
- 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.