TriangleNCT00006436 · OUTCOME
Median Interim Positron Emission Tomography (PET) Positive 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
- years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Participants were followed for up to 10.2 years to determine their response on interim PET scans.
What was measured
PFS is the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles (each cycle is 21 days + 7 days window) of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival.
Analysis population: 27 participants had no PET scan.
Groups in this outcome
Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
| Group | Source count |
|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 41 |
Reported measurements
Interim PET positive participants
| Group | Source count |
|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 10.2 | Not reported | 0.4 | NA | Upper end of the CI is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval. |
Interim PET negative participants
| Group | Source count |
|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 28 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | NA | Not reported | NA | NA | Median not reached and confidence intervals cannot be reported because of the timing of the events relative to the follow-up of all participants. |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Compared the PFS of interim PET positive participants to the PFS of interim PET negative.
- p Value
- 0.10
- statistical Method
- Two-tailed log rank test
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Compared the PFS of interim PET positive participants to the PFS of interim PET negative.
- p Value
- 0.10
- statistical Method
- Two-tailed log rank test
- classes
- categories
- measurements
- comment
- Upper end of the CI is not estimable because the number of events beyond the median, and their timing, does not permit calculation of the upper confidence interval.
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- NA
- value
- 10.2
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- title
- Interim PET positive participants
- categories
- measurements
- comment
- Median not reached and confidence intervals cannot be reported because of the timing of the events relative to the follow-up of all participants.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 28
- units
- Participants
- title
- Interim PET negative participants
- denoms
- counts
- group Id
- OG000
- value
- 41
- units
- Participants
- description
- PFS is the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles (each cycle is 21 days + 7 days window) of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- id
- OG000
- title
- Arm 1-Combination Chemo and Biological Therapy
- param Type
- MEDIAN
- population Description
- 27 participants had no PET scan.
- reporting Status
- POSTED
- time Frame
- Participants were followed for up to 10.2 years to determine their response on interim PET scans.
- title
- Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice