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NCT03258554 · OUTCOME

Progression-free Survival (Percentage of Participants Alive Without Progression) by Baseline p16 Status

Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin · Source last updated 2026-08-27

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 to date of progression or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 4.2 years. Two-year PFS estimates are reported.

What was measured

Failure for progression-free survival is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Positive p16 status was defined as more than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells, confirmed by central pathology review. Treatment effect hazard ratios within p16 subgroup were estimated by Cox proportional hazards model and progression-free survival estimates were estimated by Kaplan-Meier method. Analysis was planned to occur after 69 failure events had been reported and tissue specimen analysis was complete.

Analysis population: Randomized participants with p16 status.

Groups in this outcome

RT + Cetuximab

IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.

RT + Durvalumab

IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or 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
RT + Cetuximab59
RT + Durvalumab115

Reported measurements

p16-positive

Analysis denominator · Participants

GroupSource count
RT + Cetuximab33
RT + Durvalumab68
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cetuximab74.8Not reported59.689.9Not reported
RT + Durvalumab68.8Not reported57.480.1Not reported
p16-negative

Analysis denominator · Participants

GroupSource count
RT + Cetuximab26
RT + Durvalumab47
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cetuximab48.1Not reported27.668.5Not reported
RT + Durvalumab23.2Not reported10.136.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.51
    estimate Comment
    Reference arm = RT + cetuximab
    group Description
    p16-positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.20
  2. ci Lower Limit
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.89
    estimate Comment
    Reference arm = RT + cetuximab
    group Description
    p16-negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.55
  3. group Description
    Interaction
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.61
    p Value Comment
    Testing the interaction of treatment arm and p16 status (positive, negative)
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.51
    estimate Comment
    Reference arm = RT + cetuximab
    group Description
    p16-positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.20
  2. ci Lower Limit
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.89
    estimate Comment
    Reference arm = RT + cetuximab
    group Description
    p16-negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.55
  3. group Description
    Interaction
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.61
    p Value Comment
    Testing the interaction of treatment arm and p16 status (positive, negative)
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.6
        upper Limit
        89.9
        value
        74.8
      2. group Id
        OG001
        lower Limit
        57.4
        upper Limit
        80.1
        value
        68.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    p16-positive
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.6
        upper Limit
        68.5
        value
        48.1
      2. group Id
        OG001
        lower Limit
        10.1
        upper Limit
        36.3
        value
        23.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    p16-negative
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    2. group Id
      OG001
      value
      115
    units
    Participants
description
Failure for progression-free survival is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Positive p16 status was defined as more than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells, confirmed by central pathology review. Treatment effect hazard ratios within p16 subgroup were estimated by Cox proportional hazards model and progression-free survival estimates were estimated by Kaplan-Meier method. Analysis was planned to occur after 69 failure events had been reported and tissue specimen analysis was complete.
dispersion Type
95% Confidence Interval
groups
  1. description
    IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    RT + Cetuximab
  2. description
    IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    RT + Durvalumab
param Type
NUMBER
population Description
Randomized participants with p16 status.
reporting Status
POSTED
time Frame
From randomization to date of progression or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 4.2 years. Two-year PFS estimates are reported.
title
Progression-free Survival (Percentage of Participants Alive Without Progression) by Baseline p16 Status
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice