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NCT02451943 · OUTCOME

Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma · Source last updated 2025-07-15

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
Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)

What was measured

Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales \[physical, role, cognitive, emotional, and social\]), and 9 symptom subscales \[fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea\]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.

Analysis population: All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.

Groups in this outcome

Doxorubicin + Olaratumab

75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.

Doxorubicin + Placebo

75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.

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

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab258
Doxorubicin + Placebo251

Reported measurements

Global Health Status/QoL

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab201
Doxorubicin + Placebo197
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.45Not reported1.412.10Not reported
Doxorubicin + Placebo1.84Not reported1.452.79Not reported
Role Functional Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab202
Doxorubicin + Placebo190
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.41Not reported0.991.48Not reported
Doxorubicin + Placebo1.41Not reported0.952.00Not reported
Physical Functional Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab205
Doxorubicin + Placebo209
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.81Not reported1.452.14Not reported
Doxorubicin + Placebo2.79Not reported2.073.48Not reported
Emotional Functional Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab168
Doxorubicin + Placebo171
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab3.48Not reported2.504.37Not reported
Doxorubicin + Placebo2.83Not reported2.144.34Not reported
Cognitive Functional Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab170
Doxorubicin + Placebo167
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.64Not reported1.412.14Not reported
Doxorubicin + Placebo1.45Not reported1.412.07Not reported
Social Functional Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab189
Doxorubicin + Placebo171
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.45Not reported1.381.64Not reported
Doxorubicin + Placebo1.41Not reported1.351.45Not reported
Fatigue Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab210
Doxorubicin + Placebo204
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab0.92Not reported0.761.25Not reported
Doxorubicin + Placebo0.89Not reported0.761.38Not reported
Nausea and Vomiting Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab182
Doxorubicin + Placebo173
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.45Not reported1.411.64Not reported
Doxorubicin + Placebo1.41Not reported0.951.45Not reported
Pain Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab185
Doxorubicin + Placebo183
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.64Not reported1.412.10Not reported
Doxorubicin + Placebo2.10Not reported1.452.76Not reported
Dyspnea Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab158
Doxorubicin + Placebo160
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab2.10Not reported1.452.76Not reported
Doxorubicin + Placebo2.07Not reported1.452.79Not reported
Insomnia Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab151
Doxorubicin + Placebo160
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab2.10Not reported1.452.79Not reported
Doxorubicin + Placebo1.58Not reported1.412.33Not reported
Appetite Loss Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab182
Doxorubicin + Placebo170
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.48Not reported1.452.04Not reported
Doxorubicin + Placebo1.64Not reported1.412.14Not reported
Financial Difficulties Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab132
Doxorubicin + Placebo105
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.48Not reported1.412.14Not reported
Doxorubicin + Placebo1.45Not reported1.412.10Not reported
Constipation Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab169
Doxorubicin + Placebo157
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab1.64Not reported1.412.10Not reported
Doxorubicin + Placebo1.41Not reported1.412.10Not reported
Diarrhea Symptom Scale

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab157
Doxorubicin + Placebo148
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab2.07Not reported1.452.79Not reported
Doxorubicin + Placebo2.79Not reported2.103.52Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.41
        upper Limit
        2.10
        value
        1.45
      2. group Id
        OG001
        lower Limit
        1.45
        upper Limit
        2.79
        value
        1.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        201
      2. group Id
        OG001
        value
        197
      units
      Participants
    title
    Global Health Status/QoL
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.99
        upper Limit
        1.48
        value
        1.41
      2. group Id
        OG001
        lower Limit
        0.95
        upper Limit
        2.00
        value
        1.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      2. group Id
        OG001
        value
        190
      units
      Participants
    title
    Role Functional Scale
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2.14
        value
        1.81
      2. group Id
        OG001
        lower Limit
        2.07
        upper Limit
        3.48
        value
        2.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        209
      units
      Participants
    title
    Physical Functional Scale
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.50
        upper Limit
        4.37
        value
        3.48
      2. group Id
        OG001
        lower Limit
        2.14
        upper Limit
        4.34
        value
        2.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        168
      2. group Id
        OG001
        value
        171
      units
      Participants
    title
    Emotional Functional Scale
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.41
        upper Limit
        2.14
        value
        1.64
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        2.07
        value
        1.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        170
      2. group Id
        OG001
        value
        167
      units
      Participants
    title
    Cognitive Functional Scale
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.38
        upper Limit
        1.64
        value
        1.45
      2. group Id
        OG001
        lower Limit
        1.35
        upper Limit
        1.45
        value
        1.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        171
      units
      Participants
    title
    Social Functional Scale
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.76
        upper Limit
        1.25
        value
        0.92
      2. group Id
        OG001
        lower Limit
        0.76
        upper Limit
        1.38
        value
        0.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        210
      2. group Id
        OG001
        value
        204
      units
      Participants
    title
    Fatigue Symptom Scale
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.41
        upper Limit
        1.64
        value
        1.45
      2. group Id
        OG001
        lower Limit
        0.95
        upper Limit
        1.45
        value
        1.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        182
      2. group Id
        OG001
        value
        173
      units
      Participants
    title
    Nausea and Vomiting Symptom Scale
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.41
        upper Limit
        2.10
        value
        1.64
      2. group Id
        OG001
        lower Limit
        1.45
        upper Limit
        2.76
        value
        2.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      2. group Id
        OG001
        value
        183
      units
      Participants
    title
    Pain Symptom Scale
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2.76
        value
        2.10
      2. group Id
        OG001
        lower Limit
        1.45
        upper Limit
        2.79
        value
        2.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        158
      2. group Id
        OG001
        value
        160
      units
      Participants
    title
    Dyspnea Symptom Scale
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2.79
        value
        2.10
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        2.33
        value
        1.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      2. group Id
        OG001
        value
        160
      units
      Participants
    title
    Insomnia Symptom Scale
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2.04
        value
        1.48
      2. group Id
        OG001
        lower Limit
        1.41
        upper Limit
        2.14
        value
        1.64
    denoms
    1. counts
      1. group Id
        OG000
        value
        182
      2. group Id
        OG001
        value
        170
      units
      Participants
    title
    Appetite Loss Symptom Scale
denoms
  1. counts
    1. group Id
      OG000
      value
      258
    2. group Id
      OG001
      value
      251
    units
    Participants
description
Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales \[physical, role, cognitive, emotional, and social\]), and 9 symptom subscales \[fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea\]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.
dispersion Type
95% Confidence Interval
groups
  1. description
    75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
    id
    OG000
    title
    Doxorubicin + Olaratumab
  2. description
    75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
    id
    OG001
    title
    Doxorubicin + Placebo
param Type
MEDIAN
population Description
All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
reporting Status
POSTED
time Frame
Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)
title
Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice