TriangleNCT00364013 · OUTCOME
Progression-free Survival
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 cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.
What was measured
Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. 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 - FOLFOX + Panitumumab
Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Wild-type KRAS - FOLFOX
Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Mutant KRAS - FOLFOX + Panitumumab
Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Mutant KRAS - FOLFOX
Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
| Group | Source count |
|---|---|
| Wild-type KRAS - FOLFOX + Panitumumab | 325 |
| Wild-type KRAS - FOLFOX | 331 |
| Mutant KRAS - FOLFOX + Panitumumab | 221 |
| Mutant KRAS - FOLFOX | 219 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Wild-type KRAS - FOLFOX + Panitumumab | 9.6 | Not reported | 9.2 | 11.1 | Not reported |
| Wild-type KRAS - FOLFOX | 8.0 | Not reported | 7.5 | 9.3 | Not reported |
| Mutant KRAS - FOLFOX + Panitumumab | 7.3 | Not reported | 6.3 | 8.0 | Not reported |
| Mutant KRAS - FOLFOX | 8.8 | Not reported | 7.7 | 9.4 | Not reported |
Source statistical analyses
- estimate Comment
- A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.
- group Description
- PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0234
- p Value Comment
- P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
- param Type
- Normal score
- param Value
- -2.27
- statistical Method
- Stratified log-rank test
- estimate Comment
- A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.
- group Description
- PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0227
- p Value Comment
- P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
- param Type
- Normal score
- param Value
- 2.28
- 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 FOLFOX arm and therefore a longer progression-free survival time.
- group Description
- PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0234
- p Value Comment
- P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
- param Type
- Normal score
- param Value
- -2.27
- statistical Method
- Stratified log-rank test
- estimate Comment
- A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.
- group Description
- PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0227
- p Value Comment
- P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
- param Type
- Normal score
- param Value
- 2.28
- statistical Method
- Stratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.2
- upper Limit
- 11.1
- value
- 9.6
- group Id
- OG001
- lower Limit
- 7.5
- upper Limit
- 9.3
- value
- 8.0
- group Id
- OG002
- lower Limit
- 6.3
- upper Limit
- 8.0
- value
- 7.3
- group Id
- OG003
- lower Limit
- 7.7
- upper Limit
- 9.4
- value
- 8.8
- denoms
- counts
- group Id
- OG000
- value
- 325
- group Id
- OG001
- value
- 331
- group Id
- OG002
- value
- 221
- group Id
- OG003
- value
- 219
- units
- Participants
- description
- Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. 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 panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Wild-type KRAS - FOLFOX + Panitumumab
- description
- Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
- id
- OG001
- title
- Wild-type KRAS - FOLFOX
- description
- Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
- id
- OG002
- title
- Mutant KRAS - FOLFOX + Panitumumab
- description
- Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
- id
- OG003
- title
- Mutant KRAS - FOLFOX
- 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 cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.
- title
- Progression-free Survival
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Independent clinical review pending · Not medical advice