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NCT00265941 · OUTCOME

Progression-free Survival (PFS) (3-year Rate Reported)

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

Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression 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. Distant progression is defined as clear evidence of distant metastases.

Analysis population: Randomized eligible patients with follow-up data

Groups in this outcome

RT + Cisplatin

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin

RT + Cisplatin + Cetuximab

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab

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

Analysis denominator · Participants

GroupSource count
RT + Cisplatin447
RT + Cisplatin + Cetuximab444

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cisplatin61.2Not reported56.765.8Not reported
RT + Cisplatin + Cetuximab58.9Not reported54.263.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.32
    estimate Comment
    Reference arm = RT + cisplatin
    group Description
    A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.76
    param Type
    Hazard Ratio (HR)
    param Value
    1.08
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.32
    estimate Comment
    Reference arm = RT + cisplatin
    group Description
    A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.76
    param Type
    Hazard Ratio (HR)
    param Value
    1.08
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56.7
        upper Limit
        65.8
        value
        61.2
      2. group Id
        OG001
        lower Limit
        54.2
        upper Limit
        63.6
        value
        58.9
denoms
  1. counts
    1. group Id
      OG000
      value
      447
    2. group Id
      OG001
      value
      444
    units
    Participants
description
Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression 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. Distant progression is defined as clear evidence of distant metastases.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
    id
    OG000
    title
    RT + Cisplatin
  2. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
    id
    OG001
    title
    RT + Cisplatin + Cetuximab
param Type
NUMBER
population Description
Randomized eligible patients with follow-up 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
Progression-free Survival (PFS) (3-year Rate Reported)
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice