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NCT01057589 · OUTCOME

Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy

A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2013-09-18

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, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)

What was measured

EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 \[no limitation\], 2 \[some limitation\] or 3 \[severe or complete limitation\] in 5 dimensions \[mobility, self-care, usual activities, pain/comfort and anxiety/depression\]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).

Analysis population: PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.

Groups in this outcome

Pemetrexed Cisplatin Cetuximab

Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.

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

Analysis denominator · Participants

GroupSource count
Pemetrexed Cisplatin Cetuximab34

Reported measurements

Change at End of Triplet Therapy (n=29)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab0.050.230Not reportedNot reportedNot reported
Change at End of Maintenance Therapy (n=15)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-0.020.291Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.223
    p Value Comment
    P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.788
    p Value Comment
    P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.223
    p Value Comment
    P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.788
    p Value Comment
    P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.230
        value
        0.05
    title
    Change at End of Triplet Therapy (n=29)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.291
        value
        -0.02
    title
    Change at End of Maintenance Therapy (n=15)
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 \[no limitation\], 2 \[some limitation\] or 3 \[severe or complete limitation\] in 5 dimensions \[mobility, self-care, usual activities, pain/comfort and anxiety/depression\]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).
dispersion Type
Standard Deviation
groups
  1. description
    Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
    id
    OG000
    title
    Pemetrexed Cisplatin Cetuximab
param Type
MEAN
population Description
PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.
reporting Status
POSTED
time Frame
Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)
title
Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice