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NCT01412957 · OUTCOME

Overall Survival

Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer · Source last updated 2017-03-15

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 to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).

What was measured

Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.

Analysis population: Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol.

Groups in this outcome

Panitumumab + BSC

Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.

BSC Alone

Participants received best supportive care until disease progression, withdrawal of consent, or death.

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

Analysis denominator · Participants

GroupSource count
Panitumumab + BSC189
BSC Alone188

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panitumumab + BSC10.0Not reported8.711.4Not reported
BSC Alone7.4Not reported5.89.3Not 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 BSC arm and therefore a longer time to event.
    group Description
    The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0096
    param Type
    Normal score
    param Value
    -2.59
    statistical Comment
    Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
    statistical Method
    Log Rank
Complete source fields
analyses
  1. estimate Comment
    A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.
    group Description
    The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0096
    param Type
    Normal score
    param Value
    -2.59
    statistical Comment
    Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.7
        upper Limit
        11.4
        value
        10.0
      2. group Id
        OG001
        lower Limit
        5.8
        upper Limit
        9.3
        value
        7.4
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      188
    units
    Participants
description
Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
    id
    OG000
    title
    Panitumumab + BSC
  2. description
    Participants received best supportive care until disease progression, withdrawal of consent, or death.
    id
    OG001
    title
    BSC Alone
param Type
MEDIAN
population Description
Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol.
reporting Status
POSTED
time Frame
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
title
Overall Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice