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NCT01399372 · OUTCOME

Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma · Source last updated 2023-07-20

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
EORTC QLQ-C30 was administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years.

What was measured

Global Health Status is calculated from two questions on the EORTC QLQ-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Data through five years after end of protocol treatment is included in the analysis, while summary data is provided only through three years due to very few participants after that timepoint.

Analysis population: Eligible, consented to quality of life study component, and has GHS score for at least one timepoint.

Groups in this outcome

Chemotherapy

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.

Chemotherapy + Low-Dose WBRT

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.

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

Analysis denominator · Participants

GroupSource count
Chemotherapy34
Chemotherapy + Low-Dose WBRT35

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Chemotherapy30
Chemotherapy + Low-Dose WBRT34
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy62.7823.54Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT54.9026.91Not reportedNot reportedNot reported
End of cycle 4

Analysis denominator · Participants

GroupSource count
Chemotherapy25
Chemotherapy + Low-Dose WBRT28
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy67.6723.97Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT64.5820.49Not reportedNot reportedNot reported
6 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy18
Chemotherapy + Low-Dose WBRT24
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy74.5420.70Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT75.3520.48Not reportedNot reportedNot reported
12 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy12
Chemotherapy + Low-Dose WBRT23
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy78.4722.88Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT78.9924.73Not reportedNot reportedNot reported
18 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy14
Chemotherapy + Low-Dose WBRT20
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy76.7920.46Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT76.6724.27Not reportedNot reportedNot reported
24 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy12
Chemotherapy + Low-Dose WBRT14
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy70.8325.00Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT83.3321.43Not reportedNot reportedNot reported
30 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy12
Chemotherapy + Low-Dose WBRT18
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy77.0824.13Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT79.6317.90Not reportedNot reportedNot reported
36 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy10
Chemotherapy + Low-Dose WBRT15
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy75.0027.78Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT85.0013.80Not reportedNot reportedNot reported
42 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy4
Chemotherapy + Low-Dose WBRT13
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy75.0021.52Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT77.5619.95Not reportedNot reportedNot reported
48 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy7
Chemotherapy + Low-Dose WBRT8
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy79.7621.97Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT84.3819.64Not reportedNot reportedNot reported
54 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy7
Chemotherapy + Low-Dose WBRT5
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy70.2416.67Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT91.6710.21Not reportedNot reportedNot reported
60 Months Post-Treatment

Analysis denominator · Participants

GroupSource count
Chemotherapy3
Chemotherapy + Low-Dose WBRT1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy80.5617.35Not reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT83.33NANot reportedNot reportedStandard deviation cannot be computed if there is only one observation, as in this case.

Source statistical analyses

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

  1. group Description
    A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.005
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. group Description
    A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.005
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.54
        value
        62.78
      2. group Id
        OG001
        spread
        26.91
        value
        54.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        34
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.97
        value
        67.67
      2. group Id
        OG001
        spread
        20.49
        value
        64.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    End of cycle 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.70
        value
        74.54
      2. group Id
        OG001
        spread
        20.48
        value
        75.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    6 Months Post-Treatment
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.88
        value
        78.47
      2. group Id
        OG001
        spread
        24.73
        value
        78.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    12 Months Post-Treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.46
        value
        76.79
      2. group Id
        OG001
        spread
        24.27
        value
        76.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    18 Months Post-Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.00
        value
        70.83
      2. group Id
        OG001
        spread
        21.43
        value
        83.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    24 Months Post-Treatment
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.13
        value
        77.08
      2. group Id
        OG001
        spread
        17.90
        value
        79.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    30 Months Post-Treatment
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.78
        value
        75.00
      2. group Id
        OG001
        spread
        13.80
        value
        85.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        15
      units
      Participants
    title
    36 Months Post-Treatment
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.52
        value
        75.00
      2. group Id
        OG001
        spread
        19.95
        value
        77.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    42 Months Post-Treatment
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.97
        value
        79.76
      2. group Id
        OG001
        spread
        19.64
        value
        84.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    48 Months Post-Treatment
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.67
        value
        70.24
      2. group Id
        OG001
        spread
        10.21
        value
        91.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    54 Months Post-Treatment
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.35
        value
        80.56
      2. comment
        Standard deviation cannot be computed if there is only one observation, as in this case.
        group Id
        OG001
        spread
        NA
        value
        83.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    60 Months Post-Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      35
    units
    Participants
description
Global Health Status is calculated from two questions on the EORTC QLQ-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Data through five years after end of protocol treatment is included in the analysis, while summary data is provided only through three years due to very few participants after that timepoint.
dispersion Type
Standard Deviation
groups
  1. description
    Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
    id
    OG000
    title
    Chemotherapy
  2. description
    Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
    id
    OG001
    title
    Chemotherapy + Low-Dose WBRT
param Type
MEAN
population Description
Eligible, consented to quality of life study component, and has GHS score for at least one timepoint.
reporting Status
POSTED
time Frame
EORTC QLQ-C30 was administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years.
title
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice