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NCT00364013 · OUTCOME

Percentage of Participants With an Objective Response

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.

What was measured

Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.

Analysis population: KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review).

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 + Panitumumab317
Wild-type KRAS - FOLFOX323
Mutant KRAS - FOLFOX + Panitumumab215
Mutant KRAS - FOLFOX211

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Wild-type KRAS - FOLFOX + Panitumumab55.21Not reported49.5560.77Not reported
Wild-type KRAS - FOLFOX47.68Not reported42.1253.28Not reported
Mutant KRAS - FOLFOX + Panitumumab39.53Not reported32.9546.41Not reported
Mutant KRAS - FOLFOX40.28Not reported33.6147.24Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.87
    estimate Comment
    The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0684
    param Type
    Odds Ratio (OR)
    param Value
    1.35
    statistical Comment
    Adjusted for geographic region and ECOG score.
    statistical Method
    Stratified exact test
  2. ci Lower Limit
    0.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.47
    estimate Comment
    The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9822
    param Type
    Odds Ratio (OR)
    param Value
    0.98
    statistical Comment
    Adjusted for geographic region and ECOG score
    statistical Method
    Stratified exact test
Complete source fields
analyses
  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.87
    estimate Comment
    The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0684
    param Type
    Odds Ratio (OR)
    param Value
    1.35
    statistical Comment
    Adjusted for geographic region and ECOG score.
    statistical Method
    Stratified exact test
  2. ci Lower Limit
    0.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.47
    estimate Comment
    The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9822
    param Type
    Odds Ratio (OR)
    param Value
    0.98
    statistical Comment
    Adjusted for geographic region and ECOG score
    statistical Method
    Stratified exact test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.55
        upper Limit
        60.77
        value
        55.21
      2. group Id
        OG001
        lower Limit
        42.12
        upper Limit
        53.28
        value
        47.68
      3. group Id
        OG002
        lower Limit
        32.95
        upper Limit
        46.41
        value
        39.53
      4. group Id
        OG003
        lower Limit
        33.61
        upper Limit
        47.24
        value
        40.28
denoms
  1. counts
    1. group Id
      OG000
      value
      317
    2. group Id
      OG001
      value
      323
    3. group Id
      OG002
      value
      215
    4. group Id
      OG003
      value
      211
    units
    Participants
description
Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.
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
NUMBER
population Description
KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review).
reporting Status
POSTED
time Frame
Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
title
Percentage of Participants With an Objective Response
type
SECONDARY
unit Of Measure
percentage of participants

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

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