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3

Indication details

Combined Agent(s)
Interferon
Control Arm
Interferon + placebo
Therapeutic Indication
In combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Renal cell cancer
Tumour Stage
Metastatic
Trial Name
AVOREN
NCT Number
NCT00738530 (BO17705E in CenterWatch)
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval
EMA Approval
EMA (CHMP) September 2012 EC decision November 2012

Primary Outcome(s)

Primary Outcome(s)
OS and PFS
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
5.4 months
PFS Gain
4.8 months
PFS HR
0.63 (0.52-0.75)
OS HR
Not significant (mature)

Adjustments

QoL Comment
QoL was not a prespecified endpoint

Final Score (after adjustments)

Preliminary non-curative score

3

Final non-curative score

3

Comment
Although mature OS is not significant, no downgrade as crossover was permitted and QoL cannot be assessed

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
110
Scorecard version
1
Issue date
11.12.2018
Last update
07.08.2023
Bevacizumab AVOREN

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Bevacizumab AVOREN

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
3
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 interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer
Bevacizumab + Interferon
Interferon + placebo

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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