NCT02008227 · OUTCOME

Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy · Source last updated 2019-12-20

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: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)

What was measured

TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A \>/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.

Analysis population: The PP-ITT analysis set.

Groups in this outcome

Docetaxel

Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

Atezolizumab

Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

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

Analysis denominator · Participants

Group	Source count
Docetaxel	425
Atezolizumab	425

Reported measurements

Pain in Chest

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	8.3	Not reported	4.6	12.5	Not reported
Atezolizumab	18.0	Not reported	11.0	NA	Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.

Cough

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	5.6	Not reported	4.0	12.8	Not reported
Atezolizumab	5.5	Not reported	4.2	7.9	Not reported

Dyspnea

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	2.1	Not reported	1.6	2.3	Not reported
Atezolizumab	1.8	Not reported	1.5	2.3	Not reported

Arm/Shoulder Pain

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	6.2	Not reported	4.9	14.7	Not reported
Atezolizumab	8.3	Not reported	5.8	12.8	Not reported

Source statistical analyses

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

ci Lower Limit
0.55
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.93
group Description
Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0111
param Type
Hazard Ratio (HR)
param Value
0.72
statistical Method
Log Rank
ci Lower Limit
0.84
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.33
group Description
Cough: Unstratified Analysis
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.6305
param Type
Hazard Ratio (HR)
param Value
1.06
statistical Method
Log Rank
ci Lower Limit
0.81
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.16
group Description
Dyspnea: Unstratified Analysis
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.7406
param Type
Hazard Ratio (HR)
param Value
0.97
statistical Method
Log Rank
ci Lower Limit
0.73
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.17
group Description
Arm/Shoulder Pain
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.5221
param Type
Hazard Ratio (HR)
param Value
0.92
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.55
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.93
group Description
Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.0111
param Type
Hazard Ratio (HR)
param Value
0.72
statistical Method
Log Rank
ci Lower Limit
0.84
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.33
group Description
Cough: Unstratified Analysis
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.6305
param Type
Hazard Ratio (HR)
param Value
1.06
statistical Method
Log Rank
ci Lower Limit
0.81
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.16
group Description
Dyspnea: Unstratified Analysis
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.7406
param Type
Hazard Ratio (HR)
param Value
0.97
statistical Method
Log Rank
ci Lower Limit
0.73
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.17
group Description
Arm/Shoulder Pain
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.5221
param Type
Hazard Ratio (HR)
param Value
0.92
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
4.6
upper Limit
12.5
value
8.3
comment
Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.
group Id
OG001
lower Limit
11.0
upper Limit
NA
value
18.0
title
Pain in Chest
categories
measurements
group Id
OG000
lower Limit
4.0
upper Limit
12.8
value
5.6
group Id
OG001
lower Limit
4.2
upper Limit
7.9
value
5.5
title
Cough
categories
measurements
group Id
OG000
lower Limit
1.6
upper Limit
2.3
value
2.1
group Id
OG001
lower Limit
1.5
upper Limit
2.3
value
1.8
title
Dyspnea
categories
measurements
group Id
OG000
lower Limit
4.9
upper Limit
14.7
value
6.2
group Id
OG001
lower Limit
5.8
upper Limit
12.8
value
8.3
title
Arm/Shoulder Pain

denoms

counts
group Id
OG000
value
425
group Id
OG001
value
425
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
id
OG000
title
Docetaxel
description
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
id
OG001
title
Atezolizumab

param Type

MEDIAN

population Description

The PP-ITT analysis set.

reporting Status

POSTED

time Frame

Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)

title

Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice