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NCT00949650 · OUTCOME

Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation · Source last updated 2018-04-06

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
Throughout the trial until progression (every 3 weeks).

What was measured

HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.

Analysis population: RS.

Groups in this outcome

Afatinib 40 mg

Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.

Pemetrexed/Cisplatin Chemotherapy

Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.

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

Analysis denominator · Participants

GroupSource count
Afatinib 40 mg230
Pemetrexed/Cisplatin Chemotherapy115

Reported measurements

Source class 1
Values in Months. · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Afatinib 40 mg26.97Not reported19.22NAAs only 82 patients (35.7 percent) in the Afatinib 40 mg deteriorated, the upper limit of Confidence Interval (CI) was not estimable.
Pemetrexed/Cisplatin Chemotherapy8.02Not reported4.44NAAs only 44 patients (38.3 percent) in the Pemetrexed/Cisplatin Chemotherapy deteriorated, the upper limit of the CI was not estimable.

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0062
    p Value Comment
    Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.401
    ci Pct Value
    95
    ci Upper Limit
    0.866
    estimate Comment
    Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2133
    param Type
    Hazard Ratio (HR)
    param Value
    0.589
    statistical Comment
    Cox PH regression stratified by EGFR mutation group and race.
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0062
    p Value Comment
    Two-sided p-value from log-rank test stratified by EGFR mutation group and race.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.401
    ci Pct Value
    95
    ci Upper Limit
    0.866
    estimate Comment
    Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2133
    param Type
    Hazard Ratio (HR)
    param Value
    0.589
    statistical Comment
    Cox PH regression stratified by EGFR mutation group and race.
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. comment
        As only 82 patients (35.7 percent) in the Afatinib 40 mg deteriorated, the upper limit of Confidence Interval (CI) was not estimable.
        group Id
        OG000
        lower Limit
        19.22
        upper Limit
        NA
        value
        26.97
      2. comment
        As only 44 patients (38.3 percent) in the Pemetrexed/Cisplatin Chemotherapy deteriorated, the upper limit of the CI was not estimable.
        group Id
        OG001
        lower Limit
        4.44
        upper Limit
        NA
        value
        8.02
denoms
  1. counts
    1. group Id
      OG000
      value
      230
    2. group Id
      OG001
      value
      115
    units
    Participants
description
HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    OG000
    title
    Afatinib 40 mg
  2. description
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    id
    OG001
    title
    Pemetrexed/Cisplatin Chemotherapy
param Type
MEDIAN
population Description
RS.
reporting Status
POSTED
time Frame
Throughout the trial until progression (every 3 weeks).
title
Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing
type
SECONDARY
unit Of Measure
Months.

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Preserved source evidence · Not medical advice