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NCT01041404 · OUTCOME

Overall Survival - Time to Event

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer · Source last updated 2014-11-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

What was measured

The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.

Analysis population: FAS

Groups in this outcome

Fluoropyrimidine/Cisplatin (FP)

Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.

Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Fluoropyrimidine/Cisplatin (FP)290
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)294

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fluoropyrimidine/Cisplatin (FP)11.1Not reported1013Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)13.8Not reported1216Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0046
    param Type
    Hazard Ratio (HR)
    param Value
    0.74
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0046
    param Type
    Hazard Ratio (HR)
    param Value
    0.74
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10
        upper Limit
        13
        value
        11.1
      2. group Id
        OG001
        lower Limit
        12
        upper Limit
        16
        value
        13.8
denoms
  1. counts
    1. group Id
      OG000
      value
      290
    2. group Id
      OG001
      value
      294
    units
    Participants
description
The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
    id
    OG000
    title
    Fluoropyrimidine/Cisplatin (FP)
  2. description
    Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
    id
    OG001
    title
    Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
param Type
MEDIAN
population Description
FAS
reporting Status
POSTED
time Frame
BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
title
Overall Survival - Time to Event
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice