3
Indication details
- Combined Agent(s)
- FOLFIRI (folinic acid, 5-fluorouracil, irinotecan)
- Control Arm
- FOLFIRI (folinic acid, 5-fluorouracil, irinotecan)
- FDA Therapeutic Indication
- Second-line treatment of patients with wild-type RAS mCRC who have received first-line fluoropyrimidine-based ChT (excluding irinotecan)
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Colorectal Cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- RAS-WT
- Trial Name
- 20050181 study
- NCT Number
- NCT00339183
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved in combination with FOLFIRI
- EMA Approval
- EMA approval March 2011
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.6 months
- PFS Gain
- 1.8 months
- PFS HR
- 0.70 (0.54-0.91)
- OS Control
- 13.9 months
- OS Gain
- 2.3 months
- OS HR
- 0.81 (0.63-1.03) Not significant (mature)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
- Toxicity Comment
-
>20% G3+ AEs affecting daily living
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 20
- 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.