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2

Indication details

Combined Agent(s)
Prednisone
Control Arm
Placebo–prednisone
FDA Therapeutic Indication
Treatment of mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom ChT is not yet clinically indicated
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Prostate cancer
Tumour Stage
Metastatic
Trial Name
COU-AA-302
NCT Number
NCT00887198
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval December 2012
EMA Approval
EMA (CHMP) approved November 2012. EC decision January 2013.
Comment
EMA not approved in ChT-naïve patients

Primary Outcome(s)

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

Outcome Data

OS Control
30.3 months
OS Gain
4.4 months
OS HR
0.81 (0.70-0.93)

Adjustments

QoL Comment
Not qualified for an ESMO-MCBS credit

Score (after adjustments)

Preliminary non-curative score

2

Non-curative score

2

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
388
Scorecard version
1
Issue date
07.08.2023
Last update
15.11.2024
Abiraterone COU-AA-302

PRELIMINARY SCORE

OS

ADJUSTMENTS

Not qualified for an ESMO-MCBS credit
Abiraterone COU-AA-302

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
2
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Genitourinary Cancers
Treatment of mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom ChT is not yet clinically indicated
Abiraterone + Prednisone
Placebo–prednisone

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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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