NCT02366143 · OUTCOME

Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23

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 approximately 29 months

What was measured

EORTC QLQ-C30 is a validated \& reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea \& vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998).

Analysis population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Groups in this outcome

Arm A (Atezolizumab+Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)

Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Arm C (Bevacizumab+Paclitaxel+Carboplatin)

Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

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
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	348
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	356
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	336

Reported measurements

Dyspnea in Teff-high WT Population

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	161
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	155
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	129

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	NA	Not reported	NA	NA	Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	NA	Not reported	NA	NA	Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	NA	Not reported	NA	NA	Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.

Dyspnea in ITT-WT Population

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	348
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	356
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	336

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	NA	Not reported	NA	NA	Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	NA	Not reported	NA	NA	Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	NA	Not reported	NA	NA	Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.

Source statistical analyses

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

ci Lower Limit
0.571
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.450
group Description
Teff-high WT Population
group Ids
OG001
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6899
param Type
Hazard Ratio (HR)
param Value
0.909
statistical Method
Log Rank
ci Lower Limit
0.413
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.089
group Description
Teff-high WT Population
group Ids
OG000
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1043
param Type
Hazard Ratio (HR)
param Value
0.671
statistical Method
Log Rank
ci Lower Limit
0.912
ci Pct Value
95
ci Upper Limit
1.665
group Description
ITT WT
group Ids
OG001
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1730
param Type
Hazard Ratio (HR)
param Value
1.232
statistical Method
Log Rank
ci Lower Limit
0.792
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.483
group Description
ITT WT
group Ids
OG000
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6145
param Type
Hazard Ratio (HR)
param Value
1.084
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.571
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.450
group Description
Teff-high WT Population
group Ids
OG001
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6899
param Type
Hazard Ratio (HR)
param Value
0.909
statistical Method
Log Rank
ci Lower Limit
0.413
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.089
group Description
Teff-high WT Population
group Ids
OG000
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1043
param Type
Hazard Ratio (HR)
param Value
0.671
statistical Method
Log Rank
ci Lower Limit
0.912
ci Pct Value
95
ci Upper Limit
1.665
group Description
ITT WT
group Ids
OG001
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1730
param Type
Hazard Ratio (HR)
param Value
1.232
statistical Method
Log Rank
ci Lower Limit
0.792
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.483
group Description
ITT WT
group Ids
OG000
OG002
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6145
param Type
Hazard Ratio (HR)
param Value
1.084
statistical Method
Log Rank

classes

categories
measurements
comment
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
comment
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
denoms
counts
group Id
OG000
value
161
group Id
OG001
value
155
group Id
OG002
value
129
units
Participants
title
Dyspnea in Teff-high WT Population
categories
measurements
comment
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
comment
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
denoms
counts
group Id
OG000
value
348
group Id
OG001
value
356
group Id
OG002
value
336
units
Participants
title
Dyspnea in ITT-WT Population

denoms

counts
group Id
OG000
value
348
group Id
OG001
value
356
group Id
OG002
value
336
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
id
OG000
title
Arm A (Atezolizumab+Paclitaxel+Carboplatin)
description
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
id
OG001
title
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
description
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
id
OG002
title
Arm C (Bevacizumab+Paclitaxel+Carboplatin)

param Type

MEDIAN

population Description

Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

reporting Status

POSTED

time Frame

Baseline up to approximately 29 months

title

Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice