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NCT02358031 · OUTCOME

Pembro Combo vs Control: Change From Baseline to Week 15 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score

A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) · Source last updated 2025-07-18

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

Measure
LEAST_SQUARES_MEAN
Unit
Score on a Scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Week 15

What was measured

The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score, for the first course of treatment, was compared between all participants of the pembro combo arm and the control arm as a pre-specified secondary analysis. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.

Analysis population: Participants in pembro combo arm and control arm who received ≥1 dose of study drug and with EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. 20 in control arm enrolled during enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm compared to control arm separately and not included here.

Groups in this outcome

Pembrolizumab Monotherapy (Pembro Mono)

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).

Pembrolizumab + Chemotherapy (Pembro Combo)

Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).

Cetuximab + Chemotherapy (Control)

Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab Monotherapy (Pembro Mono)0
Pembrolizumab + Chemotherapy (Pembro Combo)268
Cetuximab + Chemotherapy (Control)259

Reported measurements

Source class 1
Values in Score on a Scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + Chemotherapy (Pembro Combo)1.17Not reported-1.794.12Not reported
Cetuximab + Chemotherapy (Control)0.77Not reported-2.223.76Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -3.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.26
    group Description
    Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    0.839
    p Value Comment
    No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
    param Type
    Difference in LS Means
    param Value
    0.40
    statistical Method
    constrained Longitudinal Data Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -3.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.26
    group Description
    Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    0.839
    p Value Comment
    No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
    param Type
    Difference in LS Means
    param Value
    0.40
    statistical Method
    constrained Longitudinal Data Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        -1.79
        upper Limit
        4.12
        value
        1.17
      2. group Id
        OG002
        lower Limit
        -2.22
        upper Limit
        3.76
        value
        0.77
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      268
    3. group Id
      OG002
      value
      259
    units
    Participants
description
The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score, for the first course of treatment, was compared between all participants of the pembro combo arm and the control arm as a pre-specified secondary analysis. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).
    id
    OG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
    id
    OG001
    title
    Pembrolizumab + Chemotherapy (Pembro Combo)
  3. description
    Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
    id
    OG002
    title
    Cetuximab + Chemotherapy (Control)
param Type
LEAST_SQUARES_MEAN
population Description
Participants in pembro combo arm and control arm who received ≥1 dose of study drug and with EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. 20 in control arm enrolled during enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm compared to control arm separately and not included here.
reporting Status
POSTED
time Frame
Baseline, Week 15
title
Pembro Combo vs Control: Change From Baseline to Week 15 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
type
SECONDARY
unit Of Measure
Score on a Scale

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