TriangleNCT02358031 · OUTCOME
Pembro Mono vs Control: Change From Baseline to Week 15 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
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 developed to assess the quality of life of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the 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, with 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 mono arm and the control arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
Analysis population: All participants in the pembro mono arm and the control arm who received ≥1 dose of study drug and had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.
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 | Source count |
|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | 294 |
| Pembrolizumab + Chemotherapy (Pembro Combo) | 0 |
| Cetuximab + Chemotherapy (Control) | 279 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | 0.85 | Not reported | -1.90 | 3.59 | Not reported |
| Cetuximab + Chemotherapy (Control) | 0.60 | Not reported | -2.19 | 3.40 | Not reported |
Source statistical analyses
- ci Lower Limit
- -3.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.82
- group Description
- Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on 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
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.893
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Difference in LS Means
- param Value
- 0.24
- statistical Method
- constrained Longitudinal Data Analysis
Complete source fields
- analyses
- ci Lower Limit
- -3.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.82
- group Description
- Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on 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
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.893
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Difference in LS Means
- param Value
- 0.24
- statistical Method
- constrained Longitudinal Data Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.90
- upper Limit
- 3.59
- value
- 0.85
- group Id
- OG002
- lower Limit
- -2.19
- upper Limit
- 3.40
- value
- 0.60
- denoms
- counts
- group Id
- OG000
- value
- 294
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 279
- units
- Participants
- description
- The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the 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, with 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 mono arm and the control arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
- dispersion Type
- 95% Confidence Interval
- groups
- 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)
- 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)
- 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
- All participants in the pembro mono arm and the control arm who received ≥1 dose of study drug and had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 15
- title
- Pembro Mono vs Control: Change From Baseline to Week 15 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice