3
Indication details
- Combined Agent(s)
- Temozolomide
- Control Arm
- Temozolomide
- Therapeutic Indication
- The medical device, the NovoTTF-100A indicated for use in combination with adjuvant temozolomide as a treatment for patients with newly diagnosed GBM following surgery, chemotherapy, and radiation therapy
- Tumour Type
-
Brain Tumours
- Tumour Sub-type
- Glioblastoma
- Trial Name
- EF-14
- NCT Number
- NCT00916409
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval in October 2015 for the Second-generation Optune device. First FDA approval in 2011.
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- OS (ITT)
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 4.0 months
- PFS Gain
- 2.7 months
- PFS HR
- 0.63 (0.52-0.76)
- OS Control
- 16.0 months
- OS Gain
- 4.9 months
- OS HR
- 0.63 (0.53-0.76)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 460
- Scorecard version
- 1
- Issue date
- 26.09.2024
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.