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NCT02409342 · OUTCOME

TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] · Source last updated 2023-03-15

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 until data cut-off on 10 September 2018 (up to approximately 38 months)

What was measured

TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea \[multi-item scale\], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.

Analysis population: Analysis was performed for the TC3 or IC3-WT Populations.

Groups in this outcome

Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).

Atezolizumab

Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

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

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)98
Atezolizumab107

Reported measurements

Cough
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)NANot reportedNANAMedian TTD is not estimable by Kaplan-Meier method due to insufficient observed events. Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events
AtezolizumabNANot reported21.5NAMedian TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events. Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
Dyspnea
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)11.8Not reported6.819.5Not reported
Atezolizumab11.1Not reported7.0NAUpper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
Chest pain
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)NANot reportedNANAMedian TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events. Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
AtezolizumabNANot reportedNANAMedian TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events. Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Source statistical analyses

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

  1. ci Lower Limit
    0.477
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.030
    group Description
    Cough for TC3 or IC3-WT Populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.984
  2. ci Lower Limit
    0.569
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.604
    group Description
    Dyspnea for TC3 or IC3-WT Populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.955
  3. ci Lower Limit
    0.472
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.222
    group Description
    Chest pain for TC3 or IC3-WT Populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.024
Complete source fields
analyses
  1. ci Lower Limit
    0.477
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.030
    group Description
    Cough for TC3 or IC3-WT Populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.984
  2. ci Lower Limit
    0.569
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.604
    group Description
    Dyspnea for TC3 or IC3-WT Populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.955
  3. ci Lower Limit
    0.472
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.222
    group Description
    Chest pain for TC3 or IC3-WT Populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.024
classes
  1. categories
    1. measurements
      1. comment
        Median TTD is not estimable by Kaplan-Meier method due to insufficient observed events. Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events. Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
        group Id
        OG001
        lower Limit
        21.5
        upper Limit
        NA
        value
        NA
    title
    Cough
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.8
        upper Limit
        19.5
        value
        11.8
      2. comment
        Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
        group Id
        OG001
        lower Limit
        7.0
        upper Limit
        NA
        value
        11.1
    title
    Dyspnea
  3. categories
    1. measurements
      1. comment
        Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events. Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events. Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Chest pain
denoms
  1. counts
    1. group Id
      OG000
      value
      98
    2. group Id
      OG001
      value
      107
    units
    Participants
description
TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea \[multi-item scale\], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    id
    OG000
    title
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
  2. description
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    id
    OG001
    title
    Atezolizumab
param Type
MEDIAN
population Description
Analysis was performed for the TC3 or IC3-WT Populations.
reporting Status
POSTED
time Frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
title
TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice