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NCT00265941 · OUTCOME

Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2022-06-14

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
From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

What was measured

EGFR expression is categorized as high (\>/=80%) and low (\<80%) in order to compare outcome by favorable and unfavorable risk group, per protocol. Times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional progression (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.

Analysis population: Randomized eligible patients with follow-up and EGFR data.

Groups in this outcome

Low EGFR

Less than 80% EGFR

High EGFR

Greater than or equal to 80% EGFR

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

Analysis denominator · Participants

GroupSource count
Low EGFR235
High EGFR145

Reported measurements

Progression-free survival (PFS)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low EGFR63.5Not reported56.969.4Not reported
High EGFR60.3Not reported51.767.8Not reported
Overall survival (OS)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low EGFR76.7Not reported70.681.7Not reported
High EGFR75.0Not reported66.981.4Not reported
Loco-regional failure (LRF)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low EGFR21.7Not reported16.627.3Not reported
High EGFR19.2Not reported13.126.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.51
    estimate Comment
    Reference level = low EGFR
    group Description
    Progression-free survival is compared between favorable risk and unfavorable risk groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.60
    param Type
    Hazard Ratio (HR)
    param Value
    1.09
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.76
    estimate Comment
    Reference level = low EGFR
    group Description
    Overall survival is compared between favorable risk and unfavorable risk groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.37
    param Type
    Hazard Ratio (HR)
    param Value
    1.19
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.46
    estimate Comment
    Reference level = low EGFR
    group Description
    Local-regional failure
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.76
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.51
    estimate Comment
    Reference level = low EGFR
    group Description
    Progression-free survival is compared between favorable risk and unfavorable risk groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.60
    param Type
    Hazard Ratio (HR)
    param Value
    1.09
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.76
    estimate Comment
    Reference level = low EGFR
    group Description
    Overall survival is compared between favorable risk and unfavorable risk groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.37
    param Type
    Hazard Ratio (HR)
    param Value
    1.19
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.46
    estimate Comment
    Reference level = low EGFR
    group Description
    Local-regional failure
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.76
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56.9
        upper Limit
        69.4
        value
        63.5
      2. group Id
        OG001
        lower Limit
        51.7
        upper Limit
        67.8
        value
        60.3
    title
    Progression-free survival (PFS)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70.6
        upper Limit
        81.7
        value
        76.7
      2. group Id
        OG001
        lower Limit
        66.9
        upper Limit
        81.4
        value
        75.0
    title
    Overall survival (OS)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.6
        upper Limit
        27.3
        value
        21.7
      2. group Id
        OG001
        lower Limit
        13.1
        upper Limit
        26.1
        value
        19.2
    title
    Loco-regional failure (LRF)
denoms
  1. counts
    1. group Id
      OG000
      value
      235
    2. group Id
      OG001
      value
      145
    units
    Participants
description
EGFR expression is categorized as high (\>/=80%) and low (\<80%) in order to compare outcome by favorable and unfavorable risk group, per protocol. Times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional progression (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Less than 80% EGFR
    id
    OG000
    title
    Low EGFR
  2. description
    Greater than or equal to 80% EGFR
    id
    OG001
    title
    High EGFR
param Type
NUMBER
population Description
Randomized eligible patients with follow-up and EGFR data.
reporting Status
POSTED
time Frame
From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
title
Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice