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NCT00556322 · OUTCOME

PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)

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
weeks
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity 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. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis.

Analysis population: FAS population; Only Participants with confirmed status of EGFR were included in the analysis; 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

GroupSource count
Comparator188
Erlotinib175

Reported measurements

EGFR Positive (n=149,143)
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Comparator8.9Not reported7.112.6Not reported
Erlotinib6.3Not reported6.17.3Not reported
EGFR Negative (n=39,32)
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Comparator11.5Not reported6.714.7Not reported
Erlotinib6.7Not reported5.912.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.61
    group Description
    Comparison of EGFR positive populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0662
    param Type
    Hazard Ratio (HR)
    param Value
    1.26
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.69
    group Description
    Comparison of EGFR negative populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9403
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.61
    group Description
    Comparison of EGFR positive populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0662
    param Type
    Hazard Ratio (HR)
    param Value
    1.26
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.69
    group Description
    Comparison of EGFR negative populations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9403
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.1
        upper Limit
        12.6
        value
        8.9
      2. group Id
        OG001
        lower Limit
        6.1
        upper Limit
        7.3
        value
        6.3
    title
    EGFR Positive (n=149,143)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.7
        upper Limit
        14.7
        value
        11.5
      2. group Id
        OG001
        lower Limit
        5.9
        upper Limit
        12.0
        value
        6.7
    title
    EGFR Negative (n=39,32)
denoms
  1. counts
    1. group Id
      OG000
      value
      188
    2. group Id
      OG001
      value
      175
    units
    Participants
description
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. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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 status of EGFR were included in the analysis; 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 Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months
title
PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)
type
SECONDARY
unit Of Measure
weeks

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Preserved source evidence · Not medical advice