Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2014-05-19
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, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
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, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges 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: All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
Groups in this outcome
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
52
Reported measurements
Change in NOD at Cycle 2 (n=52)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
4.62
18.63
Not reported
Not reported
Not reported
Change in UOS at Cycle 2 (n=52)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
-2.40
18.69
Not reported
Not reported
Not reported
change in EIP at Cycle 2 (n=52)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
2.88
21.38
Not reported
Not reported
Not reported
Change in NOD at Cycle 4 (n=34)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
3.24
24.58
Not reported
Not reported
Not reported
Change in UOS at Cycle 4 (n=35)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
-0.71
19.63
Not reported
Not reported
Not reported
Change in EIP at Cycle 4 (n=34)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
-6.62
24.08
Not reported
Not reported
Not reported
Change in NOD at Cycle 6 (n=28)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
9.29
24.78
Not reported
Not reported
Not reported
Change in UOS at Cycle 6 (n=28)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
-1.79
16.57
Not reported
Not reported
Not reported
Change in EIP at Cycle 6 (n=28)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
-1.79
28.81
Not reported
Not reported
Not reported
Change in NOD at monotherapy Cycle 2 (n=16)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
11.88
32.29
Not reported
Not reported
Not reported
Change in UOS at monotherapy Cycle 2 (n=16)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
-4.69
16.38
Not reported
Not reported
Not reported
Change in EIP at monotherapy Cycle 2 (n=17)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
-4.41
35.61
Not reported
Not reported
Not reported
Change in NOD at monotherapy Cycle 4 (n=9)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
8.89
18.33
Not reported
Not reported
Not reported
Change in UOS at monotherapy Cycle 4 (n=9)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
2.78
23.20
Not reported
Not reported
Not reported
Change in EIP at monotherapy Cycle 4 (n=9)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
2.78
23.20
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
18.63
value
4.62
title
Change in NOD at Cycle 2 (n=52)
categories
measurements
group Id
OG000
spread
18.69
value
-2.40
title
Change in UOS at Cycle 2 (n=52)
categories
measurements
group Id
OG000
spread
21.38
value
2.88
title
change in EIP at Cycle 2 (n=52)
categories
measurements
group Id
OG000
spread
24.58
value
3.24
title
Change in NOD at Cycle 4 (n=34)
categories
measurements
group Id
OG000
spread
19.63
value
-0.71
title
Change in UOS at Cycle 4 (n=35)
categories
measurements
group Id
OG000
spread
24.08
value
-6.62
title
Change in EIP at Cycle 4 (n=34)
categories
measurements
group Id
OG000
spread
24.78
value
9.29
title
Change in NOD at Cycle 6 (n=28)
categories
measurements
group Id
OG000
spread
16.57
value
-1.79
title
Change in UOS at Cycle 6 (n=28)
categories
measurements
group Id
OG000
spread
28.81
value
-1.79
title
Change in EIP at Cycle 6 (n=28)
categories
measurements
group Id
OG000
spread
32.29
value
11.88
title
Change in NOD at monotherapy Cycle 2 (n=16)
categories
measurements
group Id
OG000
spread
16.38
value
-4.69
title
Change in UOS at monotherapy Cycle 2 (n=16)
categories
measurements
group Id
OG000
spread
35.61
value
-4.41
title
Change in EIP at monotherapy Cycle 2 (n=17)
denoms
counts
group Id
OG000
value
52
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, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges 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
description
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
id
OG000
title
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
param Type
MEAN
population Description
All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
reporting Status
POSTED
time Frame
Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
title
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Triangle