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NCT00265941 · OUTCOME

Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) 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

SUVmax is categorized as high (\>median) and low (\</=median). All 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 failure (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 N2-3 patients with follow-up and PET data

Groups in this outcome

Low PET SUVmax

Less than or equal to median pretreatment PET SUVmax

High PET SUVmax

Greater than median pretreatment PET SUVmax

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 PET SUVmax34
High PET SUVmax34

Reported measurements

Progression-free Survival (PFS)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low PET SUVmax55.9Not reported37.870.6Not reported
High PET SUVmax85.3Not reported68.293.6Not reported
Overall Survival (OS)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low PET SUVmax85.3Not reported68.293.6Not reported
High PET SUVmax91.2Not reported75.197.1Not reported
Loco-regional failure (LRF)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low PET SUVmax32.4Not reported17.448.3Not reported
High PET SUVmax11.8Not reported3.625.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.75
    estimate Comment
    Reference level = low
    group Description
    Progression-free survival is compared between low and high SUVmax groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.01
    param Type
    Hazard Ratio (HR)
    param Value
    0.30
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    Reference level = low
    group Description
    Overall survival (OS) is compared between low and high SUVmax groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.10
    param Type
    Hazard Ratio (HR)
    param Value
    0.38
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    estimate Comment
    Reference level = low
    group Description
    Loco-regional control (LRC) is compared between low and high SUVmax groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.04
    param Type
    Hazard Ratio (HR)
    param Value
    0.31
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.75
    estimate Comment
    Reference level = low
    group Description
    Progression-free survival is compared between low and high SUVmax groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.01
    param Type
    Hazard Ratio (HR)
    param Value
    0.30
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    Reference level = low
    group Description
    Overall survival (OS) is compared between low and high SUVmax groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.10
    param Type
    Hazard Ratio (HR)
    param Value
    0.38
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    estimate Comment
    Reference level = low
    group Description
    Loco-regional control (LRC) is compared between low and high SUVmax groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.04
    param Type
    Hazard Ratio (HR)
    param Value
    0.31
    statistical Comment
    2-sided significance level = 0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.8
        upper Limit
        70.6
        value
        55.9
      2. group Id
        OG001
        lower Limit
        68.2
        upper Limit
        93.6
        value
        85.3
    title
    Progression-free Survival (PFS)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.2
        upper Limit
        93.6
        value
        85.3
      2. group Id
        OG001
        lower Limit
        75.1
        upper Limit
        97.1
        value
        91.2
    title
    Overall Survival (OS)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.4
        upper Limit
        48.3
        value
        32.4
      2. group Id
        OG001
        lower Limit
        3.6
        upper Limit
        25.1
        value
        11.8
    title
    Loco-regional failure (LRF)
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      34
    units
    Participants
description
SUVmax is categorized as high (\>median) and low (\</=median). All 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 failure (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 or equal to median pretreatment PET SUVmax
    id
    OG000
    title
    Low PET SUVmax
  2. description
    Greater than median pretreatment PET SUVmax
    id
    OG001
    title
    High PET SUVmax
param Type
NUMBER
population Description
Randomized eligible N2-3 patients with follow-up and PET 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 Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice