4
Indication details
- Combined Agent(s)
- Chemotherapy
- Control Arm
- Paclitaxel or topotecan or liposomal doxorubicin
- 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 no more than two prior chemotherapy 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)
- 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 HR
- Not significant
Adjustments
- QoL Comment
-
Improved
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- QoL adjustment
- 1+
- Final 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
- 10.10.2022
Legend
Information about symbols, abbrevations and color codes
- 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
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include: