4
Indication details
- Control Arm
- Sunitinib
- FDA Therapeutic Indication
- First-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Metastatic
- Trial Name
- COMPARZ
- NCT Number
- NCT00720941
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved
- Comment
- This is not the registration trial with the EMA
Primary Outcome(s)
- Primary Outcome(s)
- PFS non-inferiority
- Evaluated Outcome
- PFS non-inferiority
- Form(s)
- Form 2c
Outcome Data
- PFS Control
- 9.5 months
- PFS Gain
- -1.1 months
- PFS HR
- 1.05 (0.90-1.22) <1.25 non-inferiority threshold for UL95%CI
- OS Control
- 29.3 months
- OS Gain
- -0.9 months
- OS HR
- 0.91 (0.76-1.08)
Adjustments
- QoL Comment
-
Improved QoL
- Toxicity Comment
-
Reduced toxicity
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 105
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 07.08.2023
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.