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NCT00304031 · OUTCOME

Median Overall Survival Time by MGMT Status

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma · Source last updated 2020-06-09

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 randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

What was measured

Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.

Analysis population: MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.

Groups in this outcome

Conventional Adjuvant TMZ

Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.

Dose-dense Adjuvant TMZ

Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ376
Dose-dense Adjuvant TMZ384

Reported measurements

Unmethylated MGMT

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ254
Dose-dense Adjuvant TMZ262
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ14.6Not reported13.216.5Not reported
Dose-dense Adjuvant TMZ13.3Not reported12.314.3Not reported
Methylated MGMT

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ122
Dose-dense Adjuvant TMZ122
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ21.4Not reported17.629.0Not reported
Dose-dense Adjuvant TMZ20.2Not reported15.425.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Unmethylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.44
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.99
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.62
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Methylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.86
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    1.19
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Unmethylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.44
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.99
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.62
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Methylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.86
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    1.19
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.2
        upper Limit
        16.5
        value
        14.6
      2. group Id
        OG001
        lower Limit
        12.3
        upper Limit
        14.3
        value
        13.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        254
      2. group Id
        OG001
        value
        262
      units
      Participants
    title
    Unmethylated MGMT
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.6
        upper Limit
        29.0
        value
        21.4
      2. group Id
        OG001
        lower Limit
        15.4
        upper Limit
        25.1
        value
        20.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        122
      2. group Id
        OG001
        value
        122
      units
      Participants
    title
    Methylated MGMT
denoms
  1. counts
    1. group Id
      OG000
      value
      376
    2. group Id
      OG001
      value
      384
    units
    Participants
description
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
    id
    OG000
    title
    Conventional Adjuvant TMZ
  2. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
    id
    OG001
    title
    Dose-dense Adjuvant TMZ
param Type
MEDIAN
population Description
MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
title
Median Overall Survival Time by MGMT Status
type
SECONDARY
unit Of Measure
months

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