TriangleNCT03765918 · OUTCOME
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
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 and Week 51
What was measured
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Analysis population: All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.
Groups in this outcome
Pembrolizumab + Standard of Care (SOC)
Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
Standard of Care (SOC)
Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
| Group | Source count |
|---|---|
| Pembrolizumab + Standard of Care (SOC) | 229 |
| Standard of Care (SOC) | 203 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Standard of Care (SOC) | 4.00 | Not reported | 0.67 | 7.33 | Not reported |
| Standard of Care (SOC) | 4.39 | Not reported | 0.90 | 7.87 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.07
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.
- non Inferiority Type
- OTHER
- p Value
- 0.8643
- p Value Comment
- Two-sided p-value based on cLDA model.
- param Type
- Difference in Least Square Means
- param Value
- -0.39
- statistical Method
- cLDA model
Complete source fields
- analyses
- ci Lower Limit
- -4.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.07
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.
- non Inferiority Type
- OTHER
- p Value
- 0.8643
- p Value Comment
- Two-sided p-value based on cLDA model.
- param Type
- Difference in Least Square Means
- param Value
- -0.39
- statistical Method
- cLDA model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.67
- upper Limit
- 7.33
- value
- 4.00
- group Id
- OG001
- lower Limit
- 0.90
- upper Limit
- 7.87
- value
- 4.39
- denoms
- counts
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 203
- units
- Participants
- description
- EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG000
- title
- Pembrolizumab + Standard of Care (SOC)
- description
- Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG001
- title
- Standard of Care (SOC)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 51
- title
- Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice