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NCT00932893 · OUTCOME

Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

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 up to end of treatment (up to 112 weeks)

What was measured

TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer \[EORTC QLQ-LC13\]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.

Analysis population: Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment.

Groups in this outcome

Crizotinib

Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

Chemotherapy

Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

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

Analysis denominator · Participants

GroupSource count
Crizotinib162
Chemotherapy151

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Crizotinib4.5Not reported3.06.9Not reported
Chemotherapy1.4Not reported1.01.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.373
    ci Pct Value
    95
    ci Upper Limit
    0.661
    group Description
    The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.497
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.373
    ci Pct Value
    95
    ci Upper Limit
    0.661
    group Description
    The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.497
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        6.9
        value
        4.5
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        1.6
        value
        1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      162
    2. group Id
      OG001
      value
      151
    units
    Participants
description
TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer \[EORTC QLQ-LC13\]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.
dispersion Type
95% Confidence Interval
groups
  1. description
    Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
    id
    OG000
    title
    Crizotinib
  2. description
    Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment.
reporting Status
POSTED
time Frame
Baseline up to end of treatment (up to 112 weeks)
title
Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice