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NCT01041404 · OUTCOME

Progression-Free 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 43, 85, and 127, and every 21 days thereafter until disease progression or 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 a PFS event. Participants were censored at the last date of 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

Participants received fluorouracil 800 mg/m\^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m\^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m\^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.

Trastuzumab, Fluoropyrimidine, Cisplatin

Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m\^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m\^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m\^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.

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, Cisplatin290
Trastuzumab, Fluoropyrimidine, Cisplatin294

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fluoropyrimidine, Cisplatin5.5Not reported56Not reported
Trastuzumab, Fluoropyrimidine, Cisplatin6.7Not reported68Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5
        upper Limit
        6
        value
        5.5
      2. group Id
        OG001
        lower Limit
        6
        upper Limit
        8
        value
        6.7
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 a PFS event. Participants were censored at the last date of 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 fluorouracil 800 mg/m\^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m\^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m\^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
    id
    OG000
    title
    Fluoropyrimidine, Cisplatin
  2. description
    Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m\^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m\^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m\^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
    id
    OG001
    title
    Trastuzumab, Fluoropyrimidine, Cisplatin
param Type
MEDIAN
population Description
FAS
reporting Status
POSTED
time Frame
BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
title
Progression-Free Survival - Time to Event
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice