A
Indication details
- Control Arm
- Fluorouracil or capecitabine plus cisplatin and epirubicin
- Therapeutic Indication
- Peri-operative locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric or gastroesophageal junction adenocarcinoma
- Tumour Stage
- Locally advanced
- Trial Name
- FLOT4
- NCT Number
- NCT01216644
- Trial Phase
- Phase II/III
Approval details
- Comment
- No specific licensed indication in gastric cancer
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 35 months (median) 5-years: 36%
- OS Gain
- 15 months (median) 5-years: 9%
- OS HR
- 0.77 (0.63–0.94)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Final Score (after adjustments)
- Final curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 119
- Scorecard version
- 1
- Issue date
- 03.05.2019
- Last update
- 28.11.2023
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.