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NEB

Indication details

Control Arm
5-FU + cisplatin
Therapeutic Indication
First-line therapy for advanced gastric cancer
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Gastric Cancer
Tumour Stage
Advanced
Trial Name
FLAGS
NCT Number
NCT00400179
Trial Phase
Phase III

Approval details

FDA Approval
Not FDA approved
EMA Approval
EMA (CHMP) December 2010 EC decision February 2011

Primary Outcome(s)

Primary Outcome(s)
OS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
7.9 months
OS Gain
0.7 months
OS HR
0.92 (0.80-1.05)

Adjustments

QoL Comment
No QoL benefit
Toxicity Comment
Reduced toxicity

Score (after adjustments)

Preliminary non-curative score

NEB

Non-curative score

NEB

Comment
This was not a non-inferiority study and is ineligible for credit for reduced toxicity.

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
407
Scorecard version
1
Issue date
29.11.2023
Cisplatin/S-1 FLAGS

PRELIMINARY SCORE

NEB

ADJUSTMENTS

No QoL benefit
Reduced toxicity
Cisplatin/S-1 FLAGS

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
NEB
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Gastrointestinal Cancers
First-line therapy for advanced gastric cancer
Cisplatin/S-1
5-FU + cisplatin

My watchlist

    pdf
    pptx

    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.

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