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NCT02500043 · OUTCOME

Progression-Free Survival (PFS)

Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer · Source last updated 2024-09-03

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
From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)

What was measured

PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method.

Analysis population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.

Groups in this outcome

TAS-102+BSC

Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.

Placebo+BSC

Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.

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

Analysis denominator · Participants

GroupSource count
TAS-102+BSC337
Placebo+BSC170

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TAS-102+BSC2.0Not reported1.92.3Not reported
Placebo+BSC1.8Not reported1.71.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.4674
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.7008
    group Description
    TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.5723
Complete source fields
analyses
  1. ci Lower Limit
    0.4674
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.7008
    group Description
    TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.5723
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        2.3
        value
        2.0
      2. group Id
        OG001
        lower Limit
        1.7
        upper Limit
        1.9
        value
        1.8
denoms
  1. counts
    1. group Id
      OG000
      value
      337
    2. group Id
      OG001
      value
      170
    units
    Participants
description
PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    id
    OG000
    title
    TAS-102+BSC
  2. description
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    id
    OG001
    title
    Placebo+BSC
param Type
MEDIAN
population Description
Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
reporting Status
POSTED
time Frame
From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice