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5-FU/LV (fluorouracil + leucovorin) or 5-FU/LEV (fluorouracil + levamisole)

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A

Indication details

Control Arm
Surgery alone (Meta-analysis)
Therapeutic Indication
Patients with stage II and III colon cancer (ITT and age stratified including >70 years)
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Colon Cancer
Tumour Stage
Adjuvant

Primary Outcome(s)

Primary Outcome(s)
DFS
Evaluated Outcome
DFS
Form(s)
Form 1

Outcome Data

OS Control
64% at 5-years
OS Gain
7% at 5-years
OS HR
0.76 (0.68-0.85)
DFS Control
58% at 5-years
DFS Gain
11% at 5-years
DFS HR
0.68 (0.60-0.76)

Score (after adjustments)

Curative score

A

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
262
Scorecard version
1
Issue date
06.04.2021
5-FU/LV (fluorouracil + leucovorin) or 5-FU/LEV (fluorouracil + levamisole)

PRELIMINARY SCORE

DFS

ADJUSTMENTS

5-FU/LV (fluorouracil + leucovorin) or 5-FU/LEV (fluorouracil + levamisole)

SCORE

A

Overall Survival / Disease-Free Survival / Pathological Complete Response
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
Patients with stage II and III colon cancer (ITT and age stratified including >70 years)
5-FU/LV (fluorouracil + leucovorin) or 5-FU/LEV (fluorouracil + levamisole)
Surgery alone (Meta-analysis)

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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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