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5-FU/LV (5-fluorouracil + leucovorin)

NSABP C-03
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A

Indication details

Control Arm
Lomustine (MeCCNU) + vincristine + 5-FU
Therapeutic Indication
Patients with Dukes' stage B and C colon cancer
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Colon Cancer
Tumour Stage
Adjuvant
Trial Name
NSABP C-03

Primary Outcome(s)

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

Outcome Data

OS Control
77% at 3-years
OS Gain
7% at 3-years
DFS Control
64% at 3-years
DFS Gain
9% at 3-years

Adjustments

Toxicity Comment
Less acute toxicity, late toxicity not reported

Final Score (after adjustments)

Final curative score

A

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
258
Scorecard version
1
Issue date
02.04.2021
5-FU/LV (5-fluorouracil + leucovorin) NSABP C-03

PRELIMINARY SCORE

DFS

ADJUSTMENTS

5-FU/LV (5-fluorouracil + leucovorin) NSABP C-03

FINAL 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 Dukes' stage B and C colon cancer
5-FU/LV (5-fluorouracil + leucovorin)
Lomustine (MeCCNU) + vincristine + 5-FU

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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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