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3

Indication details

Combined Agent(s)
Prednisone or prednisolone
Control Arm
Abiraterone or enzalutamide (alternative to previously used)
Therapeutic Indication
In combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Prostate cancer
Tumour Stage
Metastatic
Trial Name
CARD
NCT Number
NCT02485691
Trial Phase
Phase IV

Approval details

FDA Approval
FDA approval June 2010
EMA Approval
EMA (CHMP) January 2011 EC decision March 2011

Primary Outcome(s)

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

Outcome Data

PFS Control
3.7 months
PFS Gain
4.3 months
PFS HR
0.54 (0.40-0.73)
OS Control
11.0 months
OS Gain
2.6 months
OS HR
0.64 (0.46-0.89)

Adjustments

QoL Comment
Single symptom improvement not eligible for global QoL upgrade

Final Score (after adjustments)

Preliminary non-curative score

3

Final non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
139
Scorecard version
1
Issue date
02.12.2019
Last update
10.08.2023
Cabazitaxel CARD

PRELIMINARY SCORE

OS

ADJUSTMENTS

Cabazitaxel CARD

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
3
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
In combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen
Cabazitaxel + Prednisone or prednisolone
Abiraterone or enzalutamide (alternative to previously used)

My watchlist

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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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