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NCT02302807 · OUTCOME

Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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
Up to approximately 25 months after first participant enrolled

What was measured

DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

Analysis population: DOR analyses was performed on the subset of patients who achieved an objective response.

Groups in this outcome

Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Atezolizumab

Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

IC2/3 Chemotherapy

PD-L1 immunohistochemistry (IHC) score of IC2/3

IC2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC2/3

IC1/2/3 Chemotherapy

PD-L1 immunohistochemistry (IHC) score of IC1/2/3

IC1/2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC1/2/3

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)96
Atezolizumab71
IC2/3 Chemotherapy34
IC2/3 Atezolizumab30
IC1/2/3 Chemotherapy68
IC1/2/3 Atezolizumab51

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)5.3Not reported4.26.3Not reported
Atezolizumab21.7Not reported9.921.7Not reported
IC2/3 Chemotherapy6.4Not reported4.28.3Not reported
IC2/3 Atezolizumab13.0Not reported6.6NAThe DOR data was not mature at the time of clinical cutoff (i.e., majority of the responders are still ongoing), so the upper confidence interval was not estimable.
IC1/2/3 Chemotherapy5.5Not reported4.27.4Not reported
IC1/2/3 Atezolizumab13Not reported6.9NAThe DOR data was not mature at the time of clinical cutoff (i.e., majority of the responders are still ongoing), so the upper confidence interval was not estimable.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        6.3
        value
        5.3
      2. group Id
        OG001
        lower Limit
        9.9
        upper Limit
        21.7
        value
        21.7
      3. group Id
        OG002
        lower Limit
        4.2
        upper Limit
        8.3
        value
        6.4
      4. comment
        The DOR data was not mature at the time of clinical cutoff (i.e., majority of the responders are still ongoing), so the upper confidence interval was not estimable.
        group Id
        OG003
        lower Limit
        6.6
        upper Limit
        NA
        value
        13.0
      5. group Id
        OG004
        lower Limit
        4.2
        upper Limit
        7.4
        value
        5.5
      6. comment
        The DOR data was not mature at the time of clinical cutoff (i.e., majority of the responders are still ongoing), so the upper confidence interval was not estimable.
        group Id
        OG005
        lower Limit
        6.9
        upper Limit
        NA
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      71
    3. group Id
      OG002
      value
      34
    4. group Id
      OG003
      value
      30
    5. group Id
      OG004
      value
      68
    6. group Id
      OG005
      value
      51
    units
    Participants
description
DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
    id
    OG000
    title
    Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
  2. description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    OG001
    title
    Atezolizumab
  3. description
    PD-L1 immunohistochemistry (IHC) score of IC2/3
    id
    OG002
    title
    IC2/3 Chemotherapy
  4. description
    PD-L1 immunohistochemistry (IHC) score of IC2/3
    id
    OG003
    title
    IC2/3 Atezolizumab
  5. description
    PD-L1 immunohistochemistry (IHC) score of IC1/2/3
    id
    OG004
    title
    IC1/2/3 Chemotherapy
  6. description
    PD-L1 immunohistochemistry (IHC) score of IC1/2/3
    id
    OG005
    title
    IC1/2/3 Atezolizumab
param Type
MEDIAN
population Description
DOR analyses was performed on the subset of patients who achieved an objective response.
reporting Status
POSTED
time Frame
Up to approximately 25 months after first participant enrolled
title
Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice