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FOLFOX (folinic acid, fluorouracil, oxaliplatin)

ABC-06
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1

Indication details

Control Arm
Symptomatic care
Therapeutic Indication
Second-line treatment of advanced biliary tract cancer
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Biliary tract cancer
Tumour Stage
Advanced
Trial Name
ABC-06
NCT Number
NCT01926236
Trial Phase
Phase III

Primary Outcome(s)

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

Outcome Data

OS Control
5.3 months
OS Gain
0.9 months
OS HR
0.69 (0.50-0.97)

Adjustments

QoL Comment
QoL data pending

Score (after adjustments)

Preliminary non-curative score

1

Non-curative score

1

Comment
Regimen without a specific licensed indication in biliary cancer.

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
315
Scorecard version
1
Issue date
15.02.2022
FOLFOX (folinic acid, fluorouracil, oxaliplatin) ABC-06

PRELIMINARY SCORE

OS

ADJUSTMENTS

?
QoL data pending
FOLFOX (folinic acid, fluorouracil, oxaliplatin) ABC-06

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
1
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
Second-line treatment of advanced biliary tract cancer
FOLFOX (folinic acid, fluorouracil, oxaliplatin)
Symptomatic care

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    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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