TriangleNCT00339183 · OUTCOME
Percentage of Participants With an Objective Response
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
- Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.
What was measured
Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.
Analysis population: KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.
Groups in this outcome
Wild-type KRAS - Panitumumab Plus FOLFIRI
Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Wild-type KRAS - FOLFIRI Alone
Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Mutant KRAS - Panitumumab Plus FOLFIRI
Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Mutant KRAS - FOLFIRI Alone
Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
| Group | Source count |
|---|---|
| Wild-type KRAS - Panitumumab Plus FOLFIRI | 297 |
| Wild-type KRAS - FOLFIRI Alone | 285 |
| Mutant KRAS - Panitumumab Plus FOLFIRI | 232 |
| Mutant KRAS - FOLFIRI Alone | 237 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Wild-type KRAS - Panitumumab Plus FOLFIRI | 35.35 | Not reported | 29.92 | 41.08 | Not reported |
| Wild-type KRAS - FOLFIRI Alone | 9.82 | Not reported | 6.63 | 13.89 | Not reported |
| Mutant KRAS - Panitumumab Plus FOLFIRI | 13.36 | Not reported | 9.26 | 18.43 | Not reported |
| Mutant KRAS - FOLFIRI Alone | 13.92 | Not reported | 9.78 | 19.00 | Not reported |
Source statistical analyses
- ci Lower Limit
- 3.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.60
- estimate Comment
- The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 5.33
- statistical Comment
- Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.
- statistical Method
- Stratified exact test
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.76
- estimate Comment
- The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 1.0000
- param Type
- Odds Ratio (OR)
- param Value
- 1.00
- statistical Comment
- Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.
- statistical Method
- Stratified exact test
Complete source fields
- analyses
- ci Lower Limit
- 3.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.60
- estimate Comment
- The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 5.33
- statistical Comment
- Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.
- statistical Method
- Stratified exact test
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.76
- estimate Comment
- The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 1.0000
- param Type
- Odds Ratio (OR)
- param Value
- 1.00
- statistical Comment
- Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.
- statistical Method
- Stratified exact test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.92
- upper Limit
- 41.08
- value
- 35.35
- group Id
- OG001
- lower Limit
- 6.63
- upper Limit
- 13.89
- value
- 9.82
- group Id
- OG002
- lower Limit
- 9.26
- upper Limit
- 18.43
- value
- 13.36
- group Id
- OG003
- lower Limit
- 9.78
- upper Limit
- 19.00
- value
- 13.92
- denoms
- counts
- group Id
- OG000
- value
- 297
- group Id
- OG001
- value
- 285
- group Id
- OG002
- value
- 232
- group Id
- OG003
- value
- 237
- units
- Participants
- description
- Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
- id
- OG000
- title
- Wild-type KRAS - Panitumumab Plus FOLFIRI
- description
- Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
- id
- OG001
- title
- Wild-type KRAS - FOLFIRI Alone
- description
- Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
- id
- OG002
- title
- Mutant KRAS - Panitumumab Plus FOLFIRI
- description
- Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
- id
- OG003
- title
- Mutant KRAS - FOLFIRI Alone
- param Type
- NUMBER
- population Description
- KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.
- title
- Percentage of Participants With an Objective Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice