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NCT00556322 · OUTCOME

Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST

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
NUMBER
Unit
percentage of participants
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 Death or up to 52 months

What was measured

Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders.

Analysis population: FAS population

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 a single oral dose of erlotinib 150 mg/day as a tablet 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
Comparator221
Erlotinib203

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Comparator6.3Not reported3.510.4Not reported
Erlotinib7.9Not reported4.612.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -3.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.7
    estimate Comment
    Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5349
    p Value Comment
    p-values are based on non-stratified analysis
    param Type
    Difference in Response Rates
    param Value
    1.55
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -3.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.7
    estimate Comment
    Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5349
    p Value Comment
    p-values are based on non-stratified analysis
    param Type
    Difference in Response Rates
    param Value
    1.55
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.5
        upper Limit
        10.4
        value
        6.3
      2. group Id
        OG001
        lower Limit
        4.6
        upper Limit
        12.5
        value
        7.9
denoms
  1. counts
    1. group Id
      OG000
      value
      221
    2. group Id
      OG001
      value
      203
    units
    Participants
description
Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders.
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 a single oral dose of erlotinib 150 mg/day as a tablet until disease progression, unacceptable toxicity or death.
    id
    OG001
    title
    Erlotinib
param Type
NUMBER
population Description
FAS population
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 Death or up to 52 months
title
Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice