TriangleNCT03258554 · OUTCOME
Progression-free Survival (Percentage of Participants Alive Without Progression) by Baseline PD-L1 (Programmed Cell Death Ligand 1) Expression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to date of progression or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 4.2 years. Two-year PFS estimates are reported.
What was measured
Failure for progression-free survival is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). PD-L1 expression is defined by a combined positive score (CPS) ≥ 1, assessed by masked central analysis of baseline tissue specimens. CPS = \[(number of tumor cells positive for PD-L1) / (number of tumor cells positive for PD-L1 + number of tumor cells negative for PD-L1)\] multiplied by 100, yielding a possible score of 0 to 100. Treatment effect hazard ratios within PD-L1 subgroup were estimated by Cox proportional hazards model and progression-free survival estimates were estimated by Kaplan-Meier method. Analysis was planned to occur after 69 failure events had been reported and tissue specimen analysis was complete.
Analysis population: Randomized participants with CPS score.
Groups in this outcome
RT + Cetuximab
IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
RT + Durvalumab
IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| RT + Cetuximab | 52 |
| RT + Durvalumab | 108 |
Reported measurements
CPS ≥ 1 (PD-L1 expression)
| Group | Source count |
|---|---|
| RT + Cetuximab | 39 |
| RT + Durvalumab | 88 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT + Cetuximab | 59.9 | Not reported | 43.6 | 76.2 | Not reported |
| RT + Durvalumab | 54.8 | Not reported | 43.9 | 65.6 | Not reported |
CPS = 0 (no PD-L1 expression)
| Group | Source count |
|---|---|
| RT + Cetuximab | 13 |
| RT + Durvalumab | 20 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT + Cetuximab | 61.5 | Not reported | 35.1 | 88.0 | Not reported |
| RT + Durvalumab | 30.0 | Not reported | 9.9 | 50.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.97
- estimate Comment
- Reference arm = RT + Cetuximab
- group Description
- CPS ≥ 1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.11
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.06
- estimate Comment
- Reference arm = RT + Cetuximab
- group Description
- CPS = 0
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.64
- group Description
- Interaction
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.41
- p Value Comment
- Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.97
- estimate Comment
- Reference arm = RT + Cetuximab
- group Description
- CPS ≥ 1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.11
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.06
- estimate Comment
- Reference arm = RT + Cetuximab
- group Description
- CPS = 0
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.64
- group Description
- Interaction
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.41
- p Value Comment
- Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.6
- upper Limit
- 76.2
- value
- 59.9
- group Id
- OG001
- lower Limit
- 43.9
- upper Limit
- 65.6
- value
- 54.8
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- CPS ≥ 1 (PD-L1 expression)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.1
- upper Limit
- 88.0
- value
- 61.5
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 50.1
- value
- 30.0
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- CPS = 0 (no PD-L1 expression)
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 108
- units
- Participants
- description
- Failure for progression-free survival is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). PD-L1 expression is defined by a combined positive score (CPS) ≥ 1, assessed by masked central analysis of baseline tissue specimens. CPS = \[(number of tumor cells positive for PD-L1) / (number of tumor cells positive for PD-L1 + number of tumor cells negative for PD-L1)\] multiplied by 100, yielding a possible score of 0 to 100. Treatment effect hazard ratios within PD-L1 subgroup were estimated by Cox proportional hazards model and progression-free survival estimates were estimated by Kaplan-Meier method. Analysis was planned to occur after 69 failure events had been reported and tissue specimen analysis was complete.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- RT + Cetuximab
- description
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- RT + Durvalumab
- param Type
- NUMBER
- population Description
- Randomized participants with CPS score.
- reporting Status
- POSTED
- time Frame
- From randomization to date of progression or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 4.2 years. Two-year PFS estimates are reported.
- title
- Progression-free Survival (Percentage of Participants Alive Without Progression) by Baseline PD-L1 (Programmed Cell Death Ligand 1) Expression
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice