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NCT04737187 · OUTCOME

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in Sub-scale Scores - Kaplan-Meier Analysis

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients · Source last updated 2024-09-24

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
Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months)

What was measured

EORTC QLQ-C30: 30 item questionnaires with 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \& GHS/QoL = higher level of functioning, \& higher score for symptoms scales = higher symptom burden. Time to definitive \>=10 points deterioration: time from date of randomization to first deterioration in QoL score \>=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used.

Analysis population: Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Groups in this outcome

Trifluridine/Tipiracil + Bevacizumab

Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.

Trifluridine/Tipiracil

Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.

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

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab121
Trifluridine/Tipiracil155

Reported measurements

Physical functioning

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab108
Trifluridine/Tipiracil149
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab8.97Not reported8.1511.83Not reported
Trifluridine/Tipiracil4.50Not reported3.715.62Not reported
Role functioning

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab113
Trifluridine/Tipiracil147
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab8.57Not reported7.4910.94Not reported
Trifluridine/Tipiracil4.40Not reported3.785.06Not reported
Emotional functioning

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab97
Trifluridine/Tipiracil128
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab9.95Not reported8.5112.12Not reported
Trifluridine/Tipiracil5.85Not reported4.706.60Not reported
Cognitive functioning

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab101
Trifluridine/Tipiracil132
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab9.36Not reported8.3412.25Not reported
Trifluridine/Tipiracil4.73Not reported4.076.11Not reported
Social functioning

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab109
Trifluridine/Tipiracil137
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab8.97Not reported7.8511.86Not reported
Trifluridine/Tipiracil4.93Not reported4.145.88Not reported
Fatigue

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab121
Trifluridine/Tipiracil149
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab8.21Not reported6.119.95Not reported
Trifluridine/Tipiracil4.04Not reported3.194.83Not reported
Nausea and vomiting

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab104
Trifluridine/Tipiracil136
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab9.36Not reported8.5111.86Not reported
Trifluridine/Tipiracil5.06Not reported4.276.31Not reported
Pain

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab117
Trifluridine/Tipiracil155
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab8.57Not reported6.9610.41Not reported
Trifluridine/Tipiracil4.34Not reported3.295.16Not reported
Dyspnoea

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab94
Trifluridine/Tipiracil131
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab9.36Not reported8.5412.25Not reported
Trifluridine/Tipiracil5.65Not reported4.406.60Not reported
Insomnia

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab96
Trifluridine/Tipiracil129
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab9.36Not reported8.5412.25Not reported
Trifluridine/Tipiracil5.75Not reported4.706.80Not reported
Appetite loss

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab120
Trifluridine/Tipiracil144
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab8.34Not reported6.7010.94Not reported
Trifluridine/Tipiracil4.66Not reported3.946.04Not reported
Constipation

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab100
Trifluridine/Tipiracil128
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab9.46Not reported8.3412.12Not reported
Trifluridine/Tipiracil5.55Not reported4.636.67Not reported
Diarrhoea

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab94
Trifluridine/Tipiracil125
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab10.41Not reported8.8414.49Not reported
Trifluridine/Tipiracil5.52Not reported4.706.60Not reported
Financial difficulties

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab100
Trifluridine/Tipiracil126
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab9.36Not reported8.3412.12Not reported
Trifluridine/Tipiracil6.11Not reported5.066.93Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.15
        upper Limit
        11.83
        value
        8.97
      2. group Id
        OG001
        lower Limit
        3.71
        upper Limit
        5.62
        value
        4.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        149
      units
      Participants
    title
    Physical functioning
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.49
        upper Limit
        10.94
        value
        8.57
      2. group Id
        OG001
        lower Limit
        3.78
        upper Limit
        5.06
        value
        4.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        113
      2. group Id
        OG001
        value
        147
      units
      Participants
    title
    Role functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.51
        upper Limit
        12.12
        value
        9.95
      2. group Id
        OG001
        lower Limit
        4.70
        upper Limit
        6.60
        value
        5.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        128
      units
      Participants
    title
    Emotional functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.34
        upper Limit
        12.25
        value
        9.36
      2. group Id
        OG001
        lower Limit
        4.07
        upper Limit
        6.11
        value
        4.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      2. group Id
        OG001
        value
        132
      units
      Participants
    title
    Cognitive functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.85
        upper Limit
        11.86
        value
        8.97
      2. group Id
        OG001
        lower Limit
        4.14
        upper Limit
        5.88
        value
        4.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        137
      units
      Participants
    title
    Social functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.11
        upper Limit
        9.95
        value
        8.21
      2. group Id
        OG001
        lower Limit
        3.19
        upper Limit
        4.83
        value
        4.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        149
      units
      Participants
    title
    Fatigue
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.51
        upper Limit
        11.86
        value
        9.36
      2. group Id
        OG001
        lower Limit
        4.27
        upper Limit
        6.31
        value
        5.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        136
      units
      Participants
    title
    Nausea and vomiting
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.96
        upper Limit
        10.41
        value
        8.57
      2. group Id
        OG001
        lower Limit
        3.29
        upper Limit
        5.16
        value
        4.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        155
      units
      Participants
    title
    Pain
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.54
        upper Limit
        12.25
        value
        9.36
      2. group Id
        OG001
        lower Limit
        4.40
        upper Limit
        6.60
        value
        5.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        131
      units
      Participants
    title
    Dyspnoea
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.54
        upper Limit
        12.25
        value
        9.36
      2. group Id
        OG001
        lower Limit
        4.70
        upper Limit
        6.80
        value
        5.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        129
      units
      Participants
    title
    Insomnia
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.70
        upper Limit
        10.94
        value
        8.34
      2. group Id
        OG001
        lower Limit
        3.94
        upper Limit
        6.04
        value
        4.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      2. group Id
        OG001
        value
        144
      units
      Participants
    title
    Appetite loss
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.34
        upper Limit
        12.12
        value
        9.46
      2. group Id
        OG001
        lower Limit
        4.63
        upper Limit
        6.67
        value
        5.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        128
      units
      Participants
    title
    Constipation
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    2. group Id
      OG001
      value
      155
    units
    Participants
description
EORTC QLQ-C30: 30 item questionnaires with 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \& GHS/QoL = higher level of functioning, \& higher score for symptoms scales = higher symptom burden. Time to definitive \>=10 points deterioration: time from date of randomization to first deterioration in QoL score \>=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
    id
    OG000
    title
    Trifluridine/Tipiracil + Bevacizumab
  2. description
    Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
    id
    OG001
    title
    Trifluridine/Tipiracil
param Type
MEDIAN
population Description
Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
reporting Status
POSTED
time Frame
Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months)
title
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in Sub-scale Scores - Kaplan-Meier Analysis
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice