3
Indication details
- Combined Agent(s)
- Gemcitabine + carboplatin
- Control Arm
- Gemcitabine + carboplatin
- FDA Therapeutic Indication
- In combination with carboplatin and gemcitabine for treatment of adult patients with first recurrence platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer 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
- OCEANS
- NCT Number
- NCT00434642
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2016
- EMA Approval
- EMA (CHMP) September 2012 EC decision November 2012
Primary Outcome(s)
- Primary Outcome(s)
- PFS (crossover allowed), OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 8.4 months
- PFS Gain
- 4 months
- PFS HR
- 0.48 (0.39-0.61)
- OS Control
- 32.9 months
- OS Gain
- 0.7 months
- OS HR
- 0.95 (0.77-1.18) OS NS (mature)
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
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 40
- 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.