TriangleNCT00339183 · OUTCOME
Progression-free Survival (PFS)
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 randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.
What was measured
Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Analysis population: KRAS Efficacy Analysis Set (participants for whom KRAS status 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 | 303 |
| Wild-type KRAS - FOLFIRI Alone | 294 |
| Mutant KRAS - Panitumumab Plus FOLFIRI | 238 |
| Mutant KRAS - FOLFIRI Alone | 248 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Wild-type KRAS - Panitumumab Plus FOLFIRI | 5.9 | Not reported | 5.5 | 6.7 | Not reported |
| Wild-type KRAS - FOLFIRI Alone | 3.9 | Not reported | 3.7 | 5.3 | Not reported |
| Mutant KRAS - Panitumumab Plus FOLFIRI | 5.0 | Not reported | 3.8 | 5.6 | Not reported |
| Mutant KRAS - FOLFIRI Alone | 4.9 | Not reported | 3.6 | 5.6 | Not reported |
Source statistical analyses
- estimate Comment
- A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.
- group Description
- An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0036
- param Type
- Normal score
- param Value
- -2.91
- statistical Comment
- P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
- statistical Method
- Stratified log-rank test
- estimate Comment
- A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.
- group Description
- PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1448
- param Type
- Normal score
- param Value
- -1.46
- statistical Comment
- P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).
- statistical Method
- Stratified log-rank test
Complete source fields
- analyses
- estimate Comment
- A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.
- group Description
- An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0036
- param Type
- Normal score
- param Value
- -2.91
- statistical Comment
- P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
- statistical Method
- Stratified log-rank test
- estimate Comment
- A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.
- group Description
- PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1448
- param Type
- Normal score
- param Value
- -1.46
- statistical Comment
- P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).
- statistical Method
- Stratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 6.7
- value
- 5.9
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 5.3
- value
- 3.9
- group Id
- OG002
- lower Limit
- 3.8
- upper Limit
- 5.6
- value
- 5.0
- group Id
- OG003
- lower Limit
- 3.6
- upper Limit
- 5.6
- value
- 4.9
- denoms
- counts
- group Id
- OG000
- value
- 303
- group Id
- OG001
- value
- 294
- group Id
- OG002
- value
- 238
- group Id
- OG003
- value
- 248
- units
- Participants
- description
- Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
- 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
- MEDIAN
- population Description
- KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice