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NCT01057589 · OUTCOME

Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)

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, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)

What was measured

PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant's speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.

Analysis population: PQ Population: all randomized and treated participants with evaluable 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 Cetuximab54

Reported measurements

NOD-Change at Triplet Cycle 2 (n=53)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-0.420.8Not reportedNot reportedNot reported
NOD-Change at Triplet Cycle 4 (n=41)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab3.924.2Not reportedNot reportedNot reported
NOD-Change at Triplet Cycle 6 (n=24)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab3.323.5Not reportedNot reportedNot reported
NOD-Change at Maintenance Cycle 1 (n=23)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab0.429.9Not reportedNot reportedNot reported
NOD-Change at Maintenance Cycle 3 (n=10)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-1.021.3Not reportedNot reportedNot reported
NOD-Change at Maintenance Cycle 5 (n=6)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab8.320.4Not reportedNot reportedNot reported
NOD-Change at Maintenance Cycle 7 (n=5)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-8.011.0Not reportedNot reportedNot reported
EIP-Change at Triplet Cycle 2 (n=46)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab2.725.4Not reportedNot reportedNot reported
EIP-Change at Triplet Cycle 4 (n=37)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-6.829.3Not reportedNot reportedNot reported
EIP-Change at Triplet Cycle 6 (n=22)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-3.420.8Not reportedNot reportedNot reported
EIP-Change at Maintenance Cycle 1 (n=23)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-8.738.1Not reportedNot reportedNot reported
EIP-Change at Maintenance Cycle 3 (n=10)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-10.021.1Not reportedNot reportedNot reported
EIP-Change at Maintenance Cycle 5 (n=6)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-4.224.6Not reportedNot reportedNot reported
EIP-Change at Maintenance Cycle 7 (n=5)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-15.022.4Not reportedNot reportedNot reported
UOS-Change at Triplet Cycle 2 (n=53)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab0.518.0Not reportedNot reportedNot reported
UOS-Change at Triplet Cycle 4 (n=41)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-4.317.6Not reportedNot reportedNot reported
UOS-Change at Triplet Cycle 6 (n=24)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-10.422.0Not reportedNot reportedNot reported
UOS-Change at Maintenance Cycle 1 (n=23)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-1.114.1Not reportedNot reportedNot reported
UOS-Change at Maintenance Cycle 3 (n=10)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-2.57.9Not reportedNot reportedNot reported
UOS-Change at Maintenance Cycle 5 (n=6)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-12.534.5Not reportedNot reportedNot reported
UOS-Change at Maintenance Cycle 7 (n=5)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab-15.033.5Not 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
    0.90
    p Value Comment
    P-value is for NOD, Triplicate Combination Therapy Cycle 2. 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
    0.31
    p Value Comment
    P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  3. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.49
    p Value Comment
    P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  4. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.95
    p Value Comment
    P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  5. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.89
    p Value Comment
    P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  6. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.36
    p Value Comment
    P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  7. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.18
    p Value Comment
    P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  8. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.47
    p Value Comment
    P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  9. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.17
    p Value Comment
    P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  10. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.45
    p Value Comment
    P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  11. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.29
    p Value Comment
    P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  12. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.17
    p Value Comment
    P-value is for EIP, Maintenance Cycle 3. 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
    0.90
    p Value Comment
    P-value is for NOD, Triplicate Combination Therapy Cycle 2. 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
    0.31
    p Value Comment
    P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  3. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.49
    p Value Comment
    P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  4. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.95
    p Value Comment
    P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  5. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.89
    p Value Comment
    P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  6. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.36
    p Value Comment
    P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  7. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.18
    p Value Comment
    P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  8. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.47
    p Value Comment
    P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  9. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.17
    p Value Comment
    P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  10. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.45
    p Value Comment
    P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  11. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.29
    p Value Comment
    P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  12. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.17
    p Value Comment
    P-value is for EIP, Maintenance Cycle 3. 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
        20.8
        value
        -0.4
    title
    NOD-Change at Triplet Cycle 2 (n=53)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.2
        value
        3.9
    title
    NOD-Change at Triplet Cycle 4 (n=41)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.5
        value
        3.3
    title
    NOD-Change at Triplet Cycle 6 (n=24)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.9
        value
        0.4
    title
    NOD-Change at Maintenance Cycle 1 (n=23)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.3
        value
        -1.0
    title
    NOD-Change at Maintenance Cycle 3 (n=10)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.4
        value
        8.3
    title
    NOD-Change at Maintenance Cycle 5 (n=6)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.0
        value
        -8.0
    title
    NOD-Change at Maintenance Cycle 7 (n=5)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.4
        value
        2.7
    title
    EIP-Change at Triplet Cycle 2 (n=46)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.3
        value
        -6.8
    title
    EIP-Change at Triplet Cycle 4 (n=37)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.8
        value
        -3.4
    title
    EIP-Change at Triplet Cycle 6 (n=22)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.1
        value
        -8.7
    title
    EIP-Change at Maintenance Cycle 1 (n=23)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.1
        value
        -10.0
    title
    EIP-Change at Maintenance Cycle 3 (n=10)
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant's speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.
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 evaluable data at respective timepoint.
reporting Status
POSTED
time Frame
Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)
title
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice