TriangleNCT01154140 · OUTCOME
Time to Intracranial Progression (IC-TTP) Based on IRR
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
- Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
What was measured
IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
Analysis population: The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.
Groups in this outcome
Crizotinib
Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy
Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
| Group | Source count |
|---|---|
| Crizotinib | 172 |
| Chemotherapy | 171 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Crizotinib | NA | Not reported | NA | NA | Median and CI were not reached due to immaturity of data and low number of events. |
| Chemotherapy | 17.8 | Not reported | 13.9 | NA | Upper limit of 95% CI was not estimable due to the small number of participants who had event. |
Source statistical analyses
- ci Lower Limit
- 0.338
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.048
- group Description
- Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0347
- p Value Comment
- P-value was obtained from 1-sided unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.595
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.338
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.048
- group Description
- Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0347
- p Value Comment
- P-value was obtained from 1-sided unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.595
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median and CI were not reached due to immaturity of data and low number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of 95% CI was not estimable due to the small number of participants who had event.
- group Id
- OG001
- lower Limit
- 13.9
- upper Limit
- NA
- value
- 17.8
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 171
- units
- Participants
- description
- IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
- id
- OG000
- title
- Crizotinib
- description
- Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.
- reporting Status
- POSTED
- time Frame
- Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
- title
- Time to Intracranial Progression (IC-TTP) Based on IRR
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice