TriangleNCT04607421 · OUTCOME
SLI: Duration of Response (DOR) as Assessed by Investigator According to Line of Therapy - FAS
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of first radiographic evidence of response (CR or PR) to earliest documented PD or death due to any cause whichever occurred first (maximum up to 33.9 months)
What was measured
DOR: time from date of first radiographic evidence of response (CR/PR) to earliest documented PD per RECIST v1.1 as assessed by response reported by investigator on eCRF, or death by any cause. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis \<10 mm. PR: \>=30% decrease under baseline of sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. DOR for first line and second line is presented. Analysis performed by Kaplan Meier method.
Analysis population: The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response as assessed by investigator and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.
Groups in this outcome
SLI: Cohort 1 [EC + FOLFIRI]
Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
SLI: Cohort 2 [EC + mFOLFOX6]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 20 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 17 |
Reported measurements
First Line Treatment
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 9 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 15.2 | Not reported | 10.6 | NA | The upper limit of 95% confidence interval (CI) could not be estimated due to insufficient number of participants with events. |
| SLI: Cohort 2 [EC + mFOLFOX6] | 6.9 | Not reported | 3.7 | NA | The upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
Second Line Treatment
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 11 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 12.5 | Not reported | 3.4 | 18.7 | Not reported |
| SLI: Cohort 2 [EC + mFOLFOX6] | 5.6 | Not reported | 2.7 | NA | The upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of 95% confidence interval (CI) could not be estimated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 10.6
- upper Limit
- NA
- value
- 15.2
- comment
- The upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- NA
- value
- 6.9
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- First Line Treatment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.4
- upper Limit
- 18.7
- value
- 12.5
- comment
- The upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 2.7
- upper Limit
- NA
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Second Line Treatment
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 17
- units
- Participants
- description
- DOR: time from date of first radiographic evidence of response (CR/PR) to earliest documented PD per RECIST v1.1 as assessed by response reported by investigator on eCRF, or death by any cause. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis \<10 mm. PR: \>=30% decrease under baseline of sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. DOR for first line and second line is presented. Analysis performed by Kaplan Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- SLI: Cohort 1 [EC + FOLFIRI]
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG001
- title
- SLI: Cohort 2 [EC + mFOLFOX6]
- param Type
- MEDIAN
- population Description
- The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response as assessed by investigator and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.
- reporting Status
- POSTED
- time Frame
- From date of first radiographic evidence of response (CR or PR) to earliest documented PD or death due to any cause whichever occurred first (maximum up to 33.9 months)
- title
- SLI: Duration of Response (DOR) as Assessed by Investigator According to Line of Therapy - FAS
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice