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NCT00339183 · OUTCOME

Overall Survival

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone · Source last updated 2022-09-23

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 until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months

What was measured

Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.

Analysis population: KRAS Efficacy Analysis Set

Groups in this outcome

Wild-type KRAS - Panitumumab Plus FOLFIRI

Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.

Wild-type KRAS - FOLFIRI Alone

Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.

Mutant KRAS - Panitumumab Plus FOLFIRI

Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.

Mutant KRAS - FOLFIRI Alone

Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.

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

Analysis denominator · Participants

GroupSource count
Wild-type KRAS - Panitumumab Plus FOLFIRI303
Wild-type KRAS - FOLFIRI Alone294
Mutant KRAS - Panitumumab Plus FOLFIRI238
Mutant KRAS - FOLFIRI Alone248

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Wild-type KRAS - Panitumumab Plus FOLFIRI14.5Not reported13.016.0Not reported
Wild-type KRAS - FOLFIRI Alone12.5Not reported11.214.2Not reported
Mutant KRAS - Panitumumab Plus FOLFIRI11.8Not reported10.413.3Not reported
Mutant KRAS - FOLFIRI Alone11.1Not reported10.312.4Not reported

Source statistical analyses

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

  1. estimate Comment
    A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.
    group Description
    An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1154
    param Type
    Normal score
    param Value
    -1.57
    statistical Comment
    P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
    statistical Method
    Stratified log-rank test
  2. estimate Comment
    A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.
    group Description
    The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.5503
    param Type
    Normal score
    param Value
    -0.60
    statistical Comment
    P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
    statistical Method
    Stratified log-rank test
Complete source fields
analyses
  1. estimate Comment
    A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.
    group Description
    An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1154
    param Type
    Normal score
    param Value
    -1.57
    statistical Comment
    P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
    statistical Method
    Stratified log-rank test
  2. estimate Comment
    A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.
    group Description
    The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.5503
    param Type
    Normal score
    param Value
    -0.60
    statistical Comment
    P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
    statistical Method
    Stratified log-rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.0
        upper Limit
        16.0
        value
        14.5
      2. group Id
        OG001
        lower Limit
        11.2
        upper Limit
        14.2
        value
        12.5
      3. group Id
        OG002
        lower Limit
        10.4
        upper Limit
        13.3
        value
        11.8
      4. group Id
        OG003
        lower Limit
        10.3
        upper Limit
        12.4
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      303
    2. group Id
      OG001
      value
      294
    3. group Id
      OG002
      value
      238
    4. group Id
      OG003
      value
      248
    units
    Participants
description
Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG000
    title
    Wild-type KRAS - Panitumumab Plus FOLFIRI
  2. description
    Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG001
    title
    Wild-type KRAS - FOLFIRI Alone
  3. description
    Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG002
    title
    Mutant KRAS - Panitumumab Plus FOLFIRI
  4. description
    Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG003
    title
    Mutant KRAS - FOLFIRI Alone
param Type
MEDIAN
population Description
KRAS Efficacy Analysis Set
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
title
Overall Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Independent clinical review pending · Not medical advice