NCT01154140 · OUTCOME

Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: units on a scale
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)

What was measured

EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).

Analysis population: The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.

Groups in this outcome

Crizotinib

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

Chemotherapy

Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.

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
Crizotinib	166
Chemotherapy	163

Reported measurements

QLQ-C30 Global QoL

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	5.9815	Not reported	3.92	8.05	Not reported
Chemotherapy	-7.8488	Not reported	-10.15	-5.55	Not reported

QLQ-C30 Cognitive Functioning

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	1.1836	Not reported	-0.66	3.03	Not reported
Chemotherapy	-2.1696	Not reported	-4.21	-0.13	Not reported

QLQ-C30 Emotional Functioning

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	8.7431	Not reported	6.77	10.72	Not reported
Chemotherapy	1.2266	Not reported	-0.95	3.40	Not reported

QLQ-C30 Physical Functioning

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	5.9370	Not reported	3.94	7.93	Not reported
Chemotherapy	-4.4664	Not reported	-6.59	-2.34	Not reported

QLQ-C30 Role Functioning

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	4.8122	Not reported	1.92	7.71	Not reported
Chemotherapy	-10.7391	Not reported	-13.87	-7.61	Not reported

QLQ-C30 Social Functioning

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	4.3790	Not reported	1.60	7.15	Not reported
Chemotherapy	-4.3851	Not reported	-7.37	-1.40	Not reported

Source statistical analyses

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

ci Lower Limit
10.74
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.92
group Description
QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
13.8303
statistical Method
Mixed Models Analysis
ci Lower Limit
0.60
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
6.11
group Description
QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0170
param Type
Mean Difference (Net)
param Value
3.3532
statistical Method
Mixed Models Analysis
ci Lower Limit
4.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.46
group Description
QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
7.5165
statistical Method
Mixed Models Analysis
ci Lower Limit
7.48
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
13.32
group Description
QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
10.4035
statistical Method
Mixed Models Analysis
ci Lower Limit
11.29
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.81
group Description
QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
15.5513
statistical Method
Mixed Models Analysis
ci Lower Limit
4.69
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.84
group Description
QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
8.7641
statistical Method
Mixed Models Analysis

Complete source fields

analyses

ci Lower Limit
10.74
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.92
group Description
QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
13.8303
statistical Method
Mixed Models Analysis
ci Lower Limit
0.60
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
6.11
group Description
QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0170
param Type
Mean Difference (Net)
param Value
3.3532
statistical Method
Mixed Models Analysis
ci Lower Limit
4.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.46
group Description
QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
7.5165
statistical Method
Mixed Models Analysis
ci Lower Limit
7.48
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
13.32
group Description
QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
10.4035
statistical Method
Mixed Models Analysis
ci Lower Limit
11.29
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.81
group Description
QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
15.5513
statistical Method
Mixed Models Analysis
ci Lower Limit
4.69
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.84
group Description
QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Mean Difference (Net)
param Value
8.7641
statistical Method
Mixed Models Analysis

classes

categories
measurements
group Id
OG000
lower Limit
3.92
upper Limit
8.05
value
5.9815
group Id
OG001
lower Limit
-10.15
upper Limit
-5.55
value
-7.8488
title
QLQ-C30 Global QoL
categories
measurements
group Id
OG000
lower Limit
-0.66
upper Limit
3.03
value
1.1836
group Id
OG001
lower Limit
-4.21
upper Limit
-0.13
value
-2.1696
title
QLQ-C30 Cognitive Functioning
categories
measurements
group Id
OG000
lower Limit
6.77
upper Limit
10.72
value
8.7431
group Id
OG001
lower Limit
-0.95
upper Limit
3.40
value
1.2266
title
QLQ-C30 Emotional Functioning
categories
measurements
group Id
OG000
lower Limit
3.94
upper Limit
7.93
value
5.9370
group Id
OG001
lower Limit
-6.59
upper Limit
-2.34
value
-4.4664
title
QLQ-C30 Physical Functioning
categories
measurements
group Id
OG000
lower Limit
1.92
upper Limit
7.71
value
4.8122
group Id
OG001
lower Limit
-13.87
upper Limit
-7.61
value
-10.7391
title
QLQ-C30 Role Functioning
categories
measurements
group Id
OG000
lower Limit
1.60
upper Limit
7.15
value
4.3790
group Id
OG001
lower Limit
-7.37
upper Limit
-1.40
value
-4.3851
title
QLQ-C30 Social Functioning

denoms

counts
group Id
OG000
value
166
group Id
OG001
value
163
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
id
OG000
title
Crizotinib
description
Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
id
OG001
title
Chemotherapy

param Type

MEAN

population Description

The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.

reporting Status

POSTED

time Frame

Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)

title

Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice