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NCT01419197 · OUTCOME

Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy · Source last updated 2016-10-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)

What was measured

The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.

Analysis population: Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Trastuzumab Emtansine

Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.

Treatment of Physician's Choice

Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.

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

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine297
Treatment of Physician's Choice117

Reported measurements

Cycle 2 (n=282,98)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-3.421.1Not reportedNot reportedNot reported
Treatment of Physician's Choice-9.422.1Not reportedNot reportedNot reported
Cycle 3 (n=257,86)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-4.621.1Not reportedNot reportedNot reported
Treatment of Physician's Choice-6.121.4Not reportedNot reportedNot reported
Cycle 4 (n=236,74)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-4.819.6Not reportedNot reportedNot reported
Treatment of Physician's Choice-3.824.1Not reportedNot reportedNot reported
Cycle 5 (n=224,54)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-6.622.8Not reportedNot reportedNot reported
Treatment of Physician's Choice-2.718.9Not reportedNot reportedNot reported
Cycle 6 (n=195,42)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-4.823.5Not reportedNot reportedNot reported
Treatment of Physician's Choice2.417.1Not reportedNot reportedNot reported
Cycle 7 (n=163,30)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-4.223.8Not reportedNot reportedNot reported
Treatment of Physician's Choice-1.515.6Not reportedNot reportedNot reported
Cycle 8 (n=130,20)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-7.021.0Not reportedNot reportedNot reported
Treatment of Physician's Choice2.218.6Not reportedNot reportedNot reported
Cycle 9 (n=97,15)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-5.822.2Not reportedNot reportedNot reported
Treatment of Physician's Choice6.720.1Not reportedNot reportedNot reported
Cycle 10 (n=80,7)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-8.921.2Not reportedNot reportedNot reported
Treatment of Physician's Choice1.611.9Not reportedNot reportedNot reported
Cycle 11 (n=56,8)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-10.523.1Not reportedNot reportedNot reported
Treatment of Physician's Choice0.08.4Not reportedNot reportedNot reported
Cycle 12 (n=48,7)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-11.325.8Not reportedNot reportedNot reported
Treatment of Physician's Choice1.67.7Not reportedNot reportedNot reported
Cycle 13 (n=40,5)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-10.023.3Not reportedNot reportedNot reported
Treatment of Physician's Choice2.212.2Not reportedNot reportedNot reported
Cycle 14 (n=33,5)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-10.121.8Not reportedNot reportedNot reported
Treatment of Physician's Choice0.07.9Not reportedNot reportedNot reported
Cycle 15 (n=27,3)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-13.222.0Not reportedNot reportedNot reported
Treatment of Physician's Choice0.00.0Not reportedNot reportedNot reported
Cycle 16 (n=19,3)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-12.319.6Not reportedNot reportedNot reported
Treatment of Physician's Choice-3.76.4Not reportedNot reportedNot reported
Cycle 17 (n=15,2)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-7.422.9Not reportedNot reportedNot reported
Treatment of Physician's Choice-5.67.9Not reportedNot reportedNot reported
Cycle 18 (n=11,0)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-9.112.0Not reportedNot reportedNot reported
Treatment of Physician's ChoiceNANANot reportedNot reportedThere were no participants with available data.
Cycle 19 (n=8,0)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine1.49.3Not reportedNot reportedNot reported
Treatment of Physician's ChoiceNANANot reportedNot reportedThere were no participants with available data.
Cycle 20 (n=4,0)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-5.623.1Not reportedNot reportedNot reported
Treatment of Physician's ChoiceNANANot reportedNot reportedThere were no participants with available data.
Cycle 21 (n=3,0)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-3.76.4Not reportedNot reportedNot reported
Treatment of Physician's ChoiceNANANot reportedNot reportedThere were no participants with available data.
Termination Visit (n=84,37)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine-1.621.8Not reportedNot reportedNot reported
Treatment of Physician's Choice-9.023.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.1
        value
        -3.4
      2. group Id
        OG001
        spread
        22.1
        value
        -9.4
    title
    Cycle 2 (n=282,98)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.1
        value
        -4.6
      2. group Id
        OG001
        spread
        21.4
        value
        -6.1
    title
    Cycle 3 (n=257,86)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.6
        value
        -4.8
      2. group Id
        OG001
        spread
        24.1
        value
        -3.8
    title
    Cycle 4 (n=236,74)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.8
        value
        -6.6
      2. group Id
        OG001
        spread
        18.9
        value
        -2.7
    title
    Cycle 5 (n=224,54)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.5
        value
        -4.8
      2. group Id
        OG001
        spread
        17.1
        value
        2.4
    title
    Cycle 6 (n=195,42)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.8
        value
        -4.2
      2. group Id
        OG001
        spread
        15.6
        value
        -1.5
    title
    Cycle 7 (n=163,30)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.0
        value
        -7.0
      2. group Id
        OG001
        spread
        18.6
        value
        2.2
    title
    Cycle 8 (n=130,20)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.2
        value
        -5.8
      2. group Id
        OG001
        spread
        20.1
        value
        6.7
    title
    Cycle 9 (n=97,15)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.2
        value
        -8.9
      2. group Id
        OG001
        spread
        11.9
        value
        1.6
    title
    Cycle 10 (n=80,7)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.1
        value
        -10.5
      2. group Id
        OG001
        spread
        8.4
        value
        0.0
    title
    Cycle 11 (n=56,8)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.8
        value
        -11.3
      2. group Id
        OG001
        spread
        7.7
        value
        1.6
    title
    Cycle 12 (n=48,7)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.3
        value
        -10.0
      2. group Id
        OG001
        spread
        12.2
        value
        2.2
    title
    Cycle 13 (n=40,5)
denoms
  1. counts
    1. group Id
      OG000
      value
      297
    2. group Id
      OG001
      value
      117
    units
    Participants
description
The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    id
    OG000
    title
    Trastuzumab Emtansine
  2. description
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    id
    OG001
    title
    Treatment of Physician's Choice
param Type
MEAN
population Description
Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.
reporting Status
POSTED
time Frame
Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
title
Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice