NCT00556322 · OUTCOME

Duration of OS in EGFR Positive and Negative Population

A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2015-02-23

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, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

What was measured

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.

Analysis population: FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative

Groups in this outcome

Comparator

Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.

Erlotinib

Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, 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
Comparator	188
Erlotinib	175

Reported measurements

EGFR Positive (n=149,143)

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Comparator	5.5	Not reported	4.1	7.5	Not reported
Erlotinib	5.6	Not reported	4.0	7.6	Not reported

EGFR Negative (n=39,32)

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Comparator	6.7	Not reported	3.1	11.5	Not reported
Erlotinib	5.4	Not reported	3.7	7.8	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
1.21
group Description
Comparison of EGFR positive populations
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6198
param Type
Hazard Ratio (HR)
param Value
0.94
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.55
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.62
group Description
Comparison of EGFR negative populations
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.8398
param Type
Hazard Ratio, log
param Value
0.95
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.21
group Description
Comparison of EGFR positive populations
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6198
param Type
Hazard Ratio (HR)
param Value
0.94
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.55
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.62
group Description
Comparison of EGFR negative populations
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.8398
param Type
Hazard Ratio, log
param Value
0.95
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
4.1
upper Limit
7.5
value
5.5
group Id
OG001
lower Limit
4.0
upper Limit
7.6
value
5.6
title
EGFR Positive (n=149,143)
categories
measurements
group Id
OG000
lower Limit
3.1
upper Limit
11.5
value
6.7
group Id
OG001
lower Limit
3.7
upper Limit
7.8
value
5.4
title
EGFR Negative (n=39,32)

denoms

counts
group Id
OG000
value
188
group Id
OG001
value
175
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
id
OG000
title
Comparator
description
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
id
OG001
title
Erlotinib

param Type

MEDIAN

population Description

FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative

reporting Status

POSTED

time Frame

Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

title

Duration of OS in EGFR Positive and Negative Population

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice