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NCT00364013 · OUTCOME

Overall Survival

PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy · Source last updated 2022-11-07

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 cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.

What was measured

The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date.

Analysis population: KRAS Efficacy Analysis Set

Groups in this outcome

Wild-type KRAS - FOLFOX + Panitumumab

Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Wild-type KRAS - FOLFOX

Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.

Mutant KRAS - FOLFOX + Panitumumab

Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Mutant KRAS - FOLFOX

Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.

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 - FOLFOX + Panitumumab325
Wild-type KRAS - FOLFOX331
Mutant KRAS - FOLFOX + Panitumumab221
Mutant KRAS - FOLFOX219

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Wild-type KRAS - FOLFOX + Panitumumab23.9Not reported20.328.3Not reported
Wild-type KRAS - FOLFOX19.7Not reported17.622.6Not reported
Mutant KRAS - FOLFOX + Panitumumab15.5Not reported13.117.6Not reported
Mutant KRAS - FOLFOX19.3Not reported16.521.8Not 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 FOLFOX arm and therefore a longer overall survival time.
    group Description
    Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0723
    p Value Comment
    cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
    param Type
    Normal score
    param Value
    -1.80
    statistical Method
    Stratified log-rank test
  2. estimate Comment
    A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.
    group Description
    Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0678
    p Value Comment
    P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
    param Type
    Normal score
    param Value
    1.83
    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 FOLFOX arm and therefore a longer overall survival time.
    group Description
    Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0723
    p Value Comment
    cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
    param Type
    Normal score
    param Value
    -1.80
    statistical Method
    Stratified log-rank test
  2. estimate Comment
    A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.
    group Description
    Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0678
    p Value Comment
    P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
    param Type
    Normal score
    param Value
    1.83
    statistical Method
    Stratified log-rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.3
        upper Limit
        28.3
        value
        23.9
      2. group Id
        OG001
        lower Limit
        17.6
        upper Limit
        22.6
        value
        19.7
      3. group Id
        OG002
        lower Limit
        13.1
        upper Limit
        17.6
        value
        15.5
      4. group Id
        OG003
        lower Limit
        16.5
        upper Limit
        21.8
        value
        19.3
denoms
  1. counts
    1. group Id
      OG000
      value
      325
    2. group Id
      OG001
      value
      331
    3. group Id
      OG002
      value
      221
    4. group Id
      OG003
      value
      219
    units
    Participants
description
The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Wild-type KRAS - FOLFOX + Panitumumab
  2. description
    Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
    id
    OG001
    title
    Wild-type KRAS - FOLFOX
  3. description
    Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
    id
    OG002
    title
    Mutant KRAS - FOLFOX + Panitumumab
  4. description
    Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
    id
    OG003
    title
    Mutant KRAS - FOLFOX
param Type
MEDIAN
population Description
KRAS Efficacy Analysis Set
reporting Status
POSTED
time Frame
From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

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