NCT01523587 · OUTCOME

Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy · Source last updated 2019-02-15

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: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

What was measured

Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.

Analysis population: RS

Groups in this outcome

Afatinib

Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.

Erlotinib

Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

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
Afatinib	398
Erlotinib	397

Reported measurements

Time to Deterioration - Coughing

Analysis denominator · Participants

Group	Source count
Afatinib	180
Erlotinib	182

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Afatinib	4.53	Not reported	2.86	4.93	Not reported
Erlotinib	3.65	Not reported	2.79	4.66	Not reported

Time to Deterioration - Dyspnoea

Analysis denominator · Participants

Group	Source count
Afatinib	238
Erlotinib	244

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Afatinib	2.63	Not reported	1.97	2.86	Not reported
Erlotinib	1.91	Not reported	1.87	2.33	Not reported

Time to Deterioration - Pain

Analysis denominator · Participants

Group	Source count
Afatinib	243
Erlotinib	232

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Afatinib	2.50	Not reported	2.00	2.79	Not reported
Erlotinib	2.37	Not reported	1.91	2.76	Not reported

Source statistical analyses

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

ci Lower Limit
0.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.09
estimate Comment
Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.
group Description
The results shown relate to Time to Deterioration in Coughing.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2562
p Value Comment
p-value calculated using log rank test stratified by race.
param Type
Hazard Ratio (HR)
param Value
0.89
statistical Method
Regression, Cox
ci Lower Limit
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
estimate Comment
Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.
group Description
The results shown relate to Time to Deterioration in Dyspnoea
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0078
p Value Comment
p-value calculated using log rank test stratified by race.
param Type
Hazard Ratio (HR)
param Value
0.79
statistical Method
Regression, Cox
ci Lower Limit
0.82
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.18
estimate Comment
Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.
group Description
The results shown relate to Time to Deterioration in Pain
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.8690
p Value Comment
p-value calculated using log rank test stratified by race
param Type
Hazard Ratio (HR)
param Value
0.99
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.09
estimate Comment
Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.
group Description
The results shown relate to Time to Deterioration in Coughing.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2562
p Value Comment
p-value calculated using log rank test stratified by race.
param Type
Hazard Ratio (HR)
param Value
0.89
statistical Method
Regression, Cox
ci Lower Limit
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
estimate Comment
Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.
group Description
The results shown relate to Time to Deterioration in Dyspnoea
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0078
p Value Comment
p-value calculated using log rank test stratified by race.
param Type
Hazard Ratio (HR)
param Value
0.79
statistical Method
Regression, Cox
ci Lower Limit
0.82
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.18
estimate Comment
Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.
group Description
The results shown relate to Time to Deterioration in Pain
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.8690
p Value Comment
p-value calculated using log rank test stratified by race
param Type
Hazard Ratio (HR)
param Value
0.99
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
2.86
upper Limit
4.93
value
4.53
group Id
OG001
lower Limit
2.79
upper Limit
4.66
value
3.65
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
182
units
Participants
title
Time to Deterioration - Coughing
categories
measurements
group Id
OG000
lower Limit
1.97
upper Limit
2.86
value
2.63
group Id
OG001
lower Limit
1.87
upper Limit
2.33
value
1.91
denoms
counts
group Id
OG000
value
238
group Id
OG001
value
244
units
Participants
title
Time to Deterioration - Dyspnoea
categories
measurements
group Id
OG000
lower Limit
2.00
upper Limit
2.79
value
2.50
group Id
OG001
lower Limit
1.91
upper Limit
2.76
value
2.37
denoms
counts
group Id
OG000
value
243
group Id
OG001
value
232
units
Participants
title
Time to Deterioration - Pain

denoms

counts
group Id
OG000
value
398
group Id
OG001
value
397
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
id
OG000
title
Afatinib
description
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
id
OG001
title
Erlotinib

param Type

MEDIAN

population Description

reporting Status

POSTED

time Frame

From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

title

Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice