4
Indication details
- Combined Agent(s)
- FOLFOX4 (5-fluorouracil, leucovorin, and oxaliplatin)
- Control Arm
- FOLFOX4 (5-fluorouracil, leucovorin, and oxaliplatin)
- FDA Therapeutic Indication
- First-line treatment of patients with wild-type RAS mCRC
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Colorectal Cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- RAS-WT
- Trial Name
- PRIME
- NCT Number
- NCT00364013
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2014
- EMA Approval
- EMA approval March 2011
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 9.2 months
- PFS Gain
- 1.6 months
- PFS HR
- 0.68 (0.54-0.87)
- OS Control
- 20.9 months
- OS Gain
- 7.4 months
- OS HR
- 0.74 (0.57-0.96)
Adjustments
- QoL Comment
-
QoL was a tertiary endpoint
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 15
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 08.02.2024
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.