NCT01057589 · OUTCOME

Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) 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 Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)

What was measured

Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit).

Analysis population: PQ Population: all randomized and treated participants with evaluable data for each category

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

Group	Source count
Pemetrexed Cisplatin Cetuximab	26

Reported measurements

Change at End of Triplet Therapy (n=23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pemetrexed Cisplatin Cetuximab	-1.2	14.28	Not reported	Not reported	Not reported

Change at End of Maintenance Therapy (n=11)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pemetrexed Cisplatin Cetuximab	-10.6	21.51	Not reported	Not reported	Not reported

Source statistical analyses

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

group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.697
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
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.132
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

group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.697
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
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.132
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

categories
measurements
group Id
OG000
spread
14.28
value
-1.2
title
Change at End of Triplet Therapy (n=23)
categories
measurements
group Id
OG000
spread
21.51
value
-10.6
title
Change at End of Maintenance Therapy (n=11)

denoms

counts
group Id
OG000
value
26
units
Participants

description

dispersion Type

Standard Deviation

groups

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 for each category

reporting Status

POSTED

time Frame

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

title

Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice