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NCT02008227 · OUTCOME

Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy · Source last updated 2019-12-20

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 objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

What was measured

DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.

Analysis population: The PP-ITT analysis set.

Groups in this outcome

Docetaxel

Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

Atezolizumab

Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, 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

GroupSource count
Docetaxel57
Atezolizumab58

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Docetaxel6.2Not reported4.97.6Not reported
Atezolizumab16.3Not reported10.0NAData not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.

Source statistical analyses

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

  1. ci Lower Limit
    0.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.55
    group Description
    Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.31
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.55
    group Description
    Unstratified Analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.34
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.55
    group Description
    Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.31
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.55
    group Description
    Unstratified Analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.34
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.9
        upper Limit
        7.6
        value
        6.2
      2. comment
        Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.
        group Id
        OG001
        lower Limit
        10.0
        upper Limit
        NA
        value
        16.3
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    2. group Id
      OG001
      value
      58
    units
    Participants
description
DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
dispersion Type
95% Confidence Interval
groups
  1. description
    Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
    id
    OG000
    title
    Docetaxel
  2. description
    Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
    id
    OG001
    title
    Atezolizumab
param Type
MEDIAN
population Description
The PP-ITT analysis set.
reporting Status
POSTED
time Frame
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
title
Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice