TriangleNCT02494583 · OUTCOME
Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale 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 18
What was measured
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro mono arm and SOC arm and is presented earlier in the record.
Analysis population: Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
Groups in this outcome
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
| Group | Source count |
|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | 0 |
| Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 245 |
| Placebo + SOC Chemotherapy (SOC) | 243 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + SOC Chemotherapy (Pembro Combo) | -10.12 | Not reported | -13.08 | -7.17 | Not reported |
| Placebo + SOC Chemotherapy (SOC) | -3.56 | Not reported | -6.61 | -0.51 | Not reported |
Source statistical analyses
- ci Lower Limit
- -10.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -2.58
- estimate Comment
- Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
- group Description
- Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.
- group Ids
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.001
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Difference in LS Means
- param Value
- -6.56
- statistical Method
- cLDA
Complete source fields
- analyses
- ci Lower Limit
- -10.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -2.58
- estimate Comment
- Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
- group Description
- Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.
- group Ids
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.001
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Difference in LS Means
- param Value
- -6.56
- statistical Method
- cLDA
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- -13.08
- upper Limit
- -7.17
- value
- -10.12
- group Id
- OG002
- lower Limit
- -6.61
- upper Limit
- -0.51
- value
- -3.56
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 245
- group Id
- OG002
- value
- 243
- units
- Participants
- description
- EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro mono arm and SOC arm and is presented earlier in the record.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV Q3W.
- id
- OG000
- title
- Pembrolizumab Monotherapy (Pembro Mono)
- description
- Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
- id
- OG001
- title
- Pembrolizumab + SOC Chemotherapy (Pembro Combo)
- description
- Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
- id
- OG002
- title
- Placebo + SOC Chemotherapy (SOC)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 18
- title
- Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale Score
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
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Preserved source evidence · Not medical advice