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3

Indication details

Combined Agent(s)
ChT (cisplatin + capecitabine or 5-FU)
Control Arm
ChT
FDA Therapeutic Indication
HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction in patients who have not received prior anti-cancer treatment for their metastatic disease
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Stomach or gastroesophageal junction cancer
Tumour Stage
Metastatic
Tumour Sub-Group
HER2+
Trial Name
ToGA
NCT Number
NCT01041404
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval October 2010
EMA Approval
EMA (CHMP) approval December 2009 EC decision Feburary 2010

Primary Outcome(s)

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

Outcome Data

OS Control
11.1 months
OS Gain
2.7 months
OS HR
0.74 (0.60-0.91)

Adjustments

QoL Comment
Reviewed, but not qualified for an ESMO-MCBS credit

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Comment
Licensed biosimilar formulations are available for this medicine and this may improve accessibility and sustainability

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
295
Scorecard version
1
Issue date
17.09.2021
Last update
28.11.2023
Trastuzumab ToGA

PRELIMINARY SCORE

OS

ADJUSTMENTS

Delay in deterioration did not meet MCBS QoL criteria for upgrade.
Trastuzumab ToGA

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
Gastrointestinal Cancers
HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction in patients who have not received prior anti-cancer treatment for their metastatic disease
Trastuzumab + ChT (cisplatin + capecitabine or 5-FU)
ChT

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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