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NCT00101283 · OUTCOME

Best Overall Response by RECIST Criteria (Version 1.0)

Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma · Source last updated 2023-07-03

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

Measure
NUMBER
Unit
eligible, treated participants
Interval / dispersion
Not reported
Time frame
Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression

What was measured

Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.

Analysis population: The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.

Groups in this outcome

Pemetrexed/Carboplatin

Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.

Pemetrexed/Gemcitabine

Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-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
Pemetrexed/Carboplatin16
Pemetrexed/Gemcitabine13

Reported measurements

Partial Response
Values in eligible, treated participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Carboplatin3Not reportedNot reportedNot reportedNot reported
Pemetrexed/Gemcitabine0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in eligible, treated participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Carboplatin7Not reportedNot reportedNot reportedNot reported
Pemetrexed/Gemcitabine6Not reportedNot reportedNot reportedNot reported
Progression
Values in eligible, treated participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Carboplatin5Not reportedNot reportedNot reportedNot reported
Pemetrexed/Gemcitabine5Not reportedNot reportedNot reportedNot reported
Unevaluable
Values in eligible, treated participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Carboplatin1Not reportedNot reportedNot reportedNot reported
Pemetrexed/Gemcitabine2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    5.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    41.7
    estimate Comment
    Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)
    group Description
    The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Overall Response Percent
    param Value
    18.8
  2. ci Lower Limit
    0.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    20.6
    estimate Comment
    Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)
    group Description
    The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Overall Response Percent
    param Value
    0.0
Complete source fields
analyses
  1. ci Lower Limit
    5.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    41.7
    estimate Comment
    Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)
    group Description
    The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Overall Response Percent
    param Value
    18.8
  2. ci Lower Limit
    0.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    20.6
    estimate Comment
    Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)
    group Description
    The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Overall Response Percent
    param Value
    0.0
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        6
    title
    Stable Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
    title
    Progression
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Unevaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.
groups
  1. description
    Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
    id
    OG000
    title
    Pemetrexed/Carboplatin
  2. description
    Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
    id
    OG001
    title
    Pemetrexed/Gemcitabine
param Type
NUMBER
population Description
The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.
reporting Status
POSTED
time Frame
Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression
title
Best Overall Response by RECIST Criteria (Version 1.0)
type
PRIMARY
unit Of Measure
eligible, treated participants

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Preserved source evidence · Not medical advice