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NCT00304031 · OUTCOME

Best Treatment Response 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

What was measured

Response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.0): Complete Response (CR), imaging no longer shows enhancing tumor, confirmed by a second scan ≥ 4 weeks later; Partial Response (PR), \>=50% decrease in tumor area (two diameters) with patient off all steroids, or on adrenal maintenance only; Minor Response (MR), \< 50% decrease in tumor area with patient off all steroids, or on adrenal maintenance only; Stable Disease (SD): scan shows no change with patient receiving stable/decreasing doses of steroids; Progression (P): \> 25% increase in tumor area with no decrease in steroid dose since last evaluation. 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: Per the protocol, both arms are combined to compare between MGMT status. MGMT status and treatment response was not available for all randomized eligible participants. Therefore, data was only available for 748/831 randomized eligible patients (arms combined).

Groups in this outcome

Methylated

Methylated MGMT (O\[6\]-methylguanine-DNA methyltransferase)

Unmethylated

Unmethylated MGMT (O\[6\]-methylguanine-DNA methyltransferase)

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

Analysis denominator · Participants

GroupSource count
Methylated240
Unmethylated508

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Methylated47Not reportedNot reportedNot reportedNot reported
Unmethylated67Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Methylated34Not reportedNot reportedNot reportedNot reported
Unmethylated66Not reportedNot reportedNot reportedNot reported

Minor Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Methylated31Not reportedNot reportedNot reportedNot reported
Unmethylated55Not reportedNot reportedNot reportedNot reported

Stable Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Methylated110Not reportedNot reportedNot reportedNot reported
Unmethylated243Not reportedNot reportedNot reportedNot reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Methylated18Not reportedNot reportedNot reportedNot reported
Unmethylated77Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.012
    p Value Comment
    Two-sided significance level of 0.05
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.012
    p Value Comment
    Two-sided significance level of 0.05
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        67
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        66
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        55
      title
      Minor Response
    4. measurements
      1. group Id
        OG000
        value
        110
      2. group Id
        OG001
        value
        243
      title
      Stable Response
    5. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        77
      title
      Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      240
    2. group Id
      OG001
      value
      508
    units
    Participants
description
Response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.0): Complete Response (CR), imaging no longer shows enhancing tumor, confirmed by a second scan ≥ 4 weeks later; Partial Response (PR), \>=50% decrease in tumor area (two diameters) with patient off all steroids, or on adrenal maintenance only; Minor Response (MR), \< 50% decrease in tumor area with patient off all steroids, or on adrenal maintenance only; Stable Disease (SD): scan shows no change with patient receiving stable/decreasing doses of steroids; Progression (P): \> 25% increase in tumor area with no decrease in steroid dose since last evaluation. 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.
groups
  1. description
    Methylated MGMT (O\[6\]-methylguanine-DNA methyltransferase)
    id
    OG000
    title
    Methylated
  2. description
    Unmethylated MGMT (O\[6\]-methylguanine-DNA methyltransferase)
    id
    OG001
    title
    Unmethylated
param Type
COUNT_OF_PARTICIPANTS
population Description
Per the protocol, both arms are combined to compare between MGMT status. MGMT status and treatment response was not available for all randomized eligible participants. Therefore, data was only available for 748/831 randomized eligible patients (arms combined).
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
title
Best Treatment Response by MGMT Status
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice