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NCT02075840 · OUTCOME

Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants · Source last updated 2026-05-29

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, every 4 weeks until disease progression (up to 33 months)

What was measured

The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point increase above baseline followed by death within 5 weeks from the last assessment.

Analysis population: ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.

Groups in this outcome

Alectinib

Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Crizotinib

Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

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

Analysis denominator · Participants

GroupSource count
Alectinib152
Crizotinib151

Reported measurements

Coughing
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AlectinibNANot reported24.0NAMedian deterioration not reached at CCOD
CrizotinibNANot reportedNANAMedian deterioration not reached at CCOD
Dyspnea
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib22.8Not reported11.8NAUpper limit of the CI not reached at CCOD
CrizotinibNANot reported21.0NAMedian deterioration not reached at CCOD
Pain in arm and shoulder
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AlectinibNANot reportedNANAMedian deterioration not reached at CCOD
CrizotinibNANot reportedNANAMedian deterioration not reached at CCOD
Pain in chest
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AlectinibNANot reportedNANAMedian deterioration not reached at CCOD
CrizotinibNANot reportedNANAMedian deterioration not reached at CCOD
Composite score (c, p in c, d)
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib12.7Not reported5.0NAUpper limit of the CI not reached at CCOD
Crizotinib21.0Not reported9.8NAUpper limit of the CI not reached at CCOD

Source statistical analyses

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

  1. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.74
    group Description
    Coughing
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7042
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Method
    Log Rank
  2. ci Lower Limit
    1.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.92
    group Description
    Dyspnea
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0285
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    1.76
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.61
    group Description
    Pain in arm and shoulder
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2377
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    1.43
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.24
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    group Description
    Pain in chest
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0796
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Log Rank
  5. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    group Description
    Composite score
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6435
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    1.10
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.74
    group Description
    Coughing
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7042
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Method
    Log Rank
  2. ci Lower Limit
    1.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.92
    group Description
    Dyspnea
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0285
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    1.76
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.61
    group Description
    Pain in arm and shoulder
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2377
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    1.43
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.24
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    group Description
    Pain in chest
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0796
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Log Rank
  5. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    group Description
    Composite score
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6435
    p Value Comment
    Stratified analysis
    param Type
    Hazard Ratio (HR)
    param Value
    1.10
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Median deterioration not reached at CCOD
        group Id
        OG000
        lower Limit
        24.0
        upper Limit
        NA
        value
        NA
      2. comment
        Median deterioration not reached at CCOD
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Coughing
  2. categories
    1. measurements
      1. comment
        Upper limit of the CI not reached at CCOD
        group Id
        OG000
        lower Limit
        11.8
        upper Limit
        NA
        value
        22.8
      2. comment
        Median deterioration not reached at CCOD
        group Id
        OG001
        lower Limit
        21.0
        upper Limit
        NA
        value
        NA
    title
    Dyspnea
  3. categories
    1. measurements
      1. comment
        Median deterioration not reached at CCOD
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median deterioration not reached at CCOD
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Pain in arm and shoulder
  4. categories
    1. measurements
      1. comment
        Median deterioration not reached at CCOD
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median deterioration not reached at CCOD
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Pain in chest
  5. categories
    1. measurements
      1. comment
        Upper limit of the CI not reached at CCOD
        group Id
        OG000
        lower Limit
        5.0
        upper Limit
        NA
        value
        12.7
      2. comment
        Upper limit of the CI not reached at CCOD
        group Id
        OG001
        lower Limit
        9.8
        upper Limit
        NA
        value
        21.0
    title
    Composite score (c, p in c, d)
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      151
    units
    Participants
description
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG000
    title
    Alectinib
  2. description
    Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG001
    title
    Crizotinib
param Type
MEDIAN
population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline, every 4 weeks until disease progression (up to 33 months)
title
Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice