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NCT01523587 · OUTCOME

Change in Score Over Time in Coughing,Dyspnoea and Pain

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy · Source last updated 2019-02-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
LEAST_SQUARES_MEAN
Unit
Units on a scale
Interval / dispersion
Standard Error
Time frame
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

What was measured

Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race. Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant. The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.

Analysis population: RS

Groups in this outcome

Afatinib

Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.

Erlotinib

Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

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

Analysis denominator · Participants

GroupSource count
Afatinib398
Erlotinib397

Reported measurements

Coughing

Analysis denominator · Participants

GroupSource count
Afatinib340
Erlotinib333
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Afatinib15.82.40Not reportedNot reportedNot reported
Erlotinib19.32.37Not reportedNot reportedNot reported
Dyspnoea

Analysis denominator · Participants

GroupSource count
Afatinib340
Erlotinib332
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Afatinib11.41.83Not reportedNot reportedNot reported
Erlotinib14.91.85Not reportedNot reportedNot reported
Pain

Analysis denominator · Participants

GroupSource count
Afatinib343
Erlotinib334
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Afatinib10.32.13Not reportedNot reportedNot reported
Erlotinib13.12.17Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -6.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.88
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.34
    group Description
    The results shown relate to Change in scores over time for: Coughing.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0091
    param Type
    Mean Difference (Final Values)
    param Value
    -3.5
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    -5.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.25
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.15
    group Description
    The results shown relate to Change in scores over time for: Dyspnoea.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0024
    param Type
    Mean Difference (Final Values)
    param Value
    -3.5
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    -5.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.15
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.32
    group Description
    The results shown relate to Change in scores over time for: Pain.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0384
    param Type
    Mean Difference (Final Values)
    param Value
    -2.7
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    -6.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.88
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.34
    group Description
    The results shown relate to Change in scores over time for: Coughing.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0091
    param Type
    Mean Difference (Final Values)
    param Value
    -3.5
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    -5.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.25
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.15
    group Description
    The results shown relate to Change in scores over time for: Dyspnoea.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0024
    param Type
    Mean Difference (Final Values)
    param Value
    -3.5
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    -5.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.15
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.32
    group Description
    The results shown relate to Change in scores over time for: Pain.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0384
    param Type
    Mean Difference (Final Values)
    param Value
    -2.7
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.40
        value
        15.8
      2. group Id
        OG001
        spread
        2.37
        value
        19.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        340
      2. group Id
        OG001
        value
        333
      units
      Participants
    title
    Coughing
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.83
        value
        11.4
      2. group Id
        OG001
        spread
        1.85
        value
        14.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        340
      2. group Id
        OG001
        value
        332
      units
      Participants
    title
    Dyspnoea
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.13
        value
        10.3
      2. group Id
        OG001
        spread
        2.17
        value
        13.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        343
      2. group Id
        OG001
        value
        334
      units
      Participants
    title
    Pain
denoms
  1. counts
    1. group Id
      OG000
      value
      398
    2. group Id
      OG001
      value
      397
    units
    Participants
description
Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race. Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant. The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.
dispersion Type
Standard Error
groups
  1. description
    Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
    id
    OG000
    title
    Afatinib
  2. description
    Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
    id
    OG001
    title
    Erlotinib
param Type
LEAST_SQUARES_MEAN
population Description
RS
reporting Status
POSTED
time Frame
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
title
Change in Score Over Time in Coughing,Dyspnoea and Pain
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice