2
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Treatment of aggressive and symptomatic MTC in patients with unresectable locally acvanced or metastatic disease in adults, children and adolescents aged 5 years and older. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Thyroid Cancer - medullary
- Tumour Stage
- Unresectable locally advanced or metastatic
- Tumour Sub-Group
- MKI targeting RET, VEGFR2 and EGFR
- Trial Name
- ZETA
- NCT Number
- NCT00410761
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval April 2011
- EMA Approval
- EMA (CHMP) November 2011 EC decision January 2012
Primary Outcome(s)
- Primary Outcome(s)
- mPFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 19.3 months
- PFS Gain
- 11.2 months (reported estimate)
- PFS HR
- 0.46 (0.31-0.69)
- OS HR
- OS immature, not significant
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Time to worsening of pain was assessed as a secondary endpoint; this does not constitute a QoL evaluation. - Toxicity Comment
-
Increased toxicity (11% Grade ≥3 diarrhoea vs 2%)
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Toxicity adjustment
- -1
- Final non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 137
- Scorecard version
- 1
- Issue date
- 06.11.2019
- Last update
- 21.07.2023
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.