NCT01774721 · OUTCOME

Duration of Response (DoR)

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. · Source last updated 2023-11-14

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 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)

What was measured

DoR was defined as time from first documentation of objective response(CR or PR, whichever occurred first)to date of PD/death from any cause, whichever occurred first. CR: disappearance of all target lesions (TLs), non TLs; any pathological lymph nodes (LN) must reduce in short axis to \<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\<10 mm short axis); PR:\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. PD:\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions; unequivocal progression of existing non TLs. DoR was recorded based on IRC review and investigator's assessment and summarized for subgroup of participants with objective disease response.

Analysis population: ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

Groups in this outcome

Dacomitinib

Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.

Gefitinib

Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, 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
Dacomitinib	227
Gefitinib	225

Reported measurements

DoR: IRC review

Analysis denominator · Participants

Group	Source count
Dacomitinib	170
Gefitinib	161

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Dacomitinib	14.8	Not reported	12.0	17.4	Not reported
Gefitinib	8.3	Not reported	7.4	9.2	Not reported

DoR: Investigator assessment

Analysis denominator · Participants

Group	Source count
Dacomitinib	171
Gefitinib	158

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Dacomitinib	15.9	Not reported	13.8	17.6	Not reported
Gefitinib	9.2	Not reported	8.2	11.0	Not reported

Source statistical analyses

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

ci Lower Limit
0.307
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.529
estimate Comment
Based on stratified Cox regression model
group Description
Comparison of dacomitinib vs gefitinib based on IRC review
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.403
statistical Method
1-sided stratified log-rank test
ci Lower Limit
0.418
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.711
estimate Comment
Based on stratified Cox regression model
group Description
Comparison of dacomitinib vs gefitinib based on Investigator assessment
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.545
statistical Method
1-sided stratified log-rank test

Complete source fields

analyses

ci Lower Limit
0.307
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.529
estimate Comment
Based on stratified Cox regression model
group Description
Comparison of dacomitinib vs gefitinib based on IRC review
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.403
statistical Method
1-sided stratified log-rank test
ci Lower Limit
0.418
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.711
estimate Comment
Based on stratified Cox regression model
group Description
Comparison of dacomitinib vs gefitinib based on Investigator assessment
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.545
statistical Method
1-sided stratified log-rank test

classes

categories
measurements
group Id
OG000
lower Limit
12.0
upper Limit
17.4
value
14.8
group Id
OG001
lower Limit
7.4
upper Limit
9.2
value
8.3
denoms
counts
group Id
OG000
value
170
group Id
OG001
value
161
units
Participants
title
DoR: IRC review
categories
measurements
group Id
OG000
lower Limit
13.8
upper Limit
17.6
value
15.9
group Id
OG001
lower Limit
8.2
upper Limit
11.0
value
9.2
denoms
counts
group Id
OG000
value
171
group Id
OG001
value
158
units
Participants
title
DoR: Investigator assessment

denoms

counts
group Id
OG000
value
227
group Id
OG001
value
225
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
id
OG000
title
Dacomitinib
description
Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
id
OG001
title
Gefitinib

param Type

MEDIAN

population Description

ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

reporting Status

POSTED

time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)

title

Duration of Response (DoR)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice