TriangleNCT02485691 · OUTCOME
Duration of Tumor Response
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 the date of the first response to the date of first documented tumor progression, or death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
What was measured
Duration of tumor response was defined as the time (in months) from date of first response (CR or PR) until date of first documentation of tumor progression or death, whichever occurs first. As per RECIST 1.1 CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression was defined as at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Analysis population: Analysis was performed on subset of participants with overall objective tumor response.
Groups in this outcome
Cabazitaxel
Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
Abiraterone Acetate or Enzalutamide
Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
| Group | Source count |
|---|---|
| Cabazitaxel | 23 |
| Abiraterone Acetate or Enzalutamide | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel | 6.5 | Not reported | 5.6 | 11.4 | Not reported |
| Abiraterone Acetate or Enzalutamide | 8.0 | Not reported | 1.1 | NA | Upper limit of Confidence Interval (CI) was not estimable due to less number of participants with overall objective tumor response. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 11.4
- value
- 6.5
- comment
- Upper limit of Confidence Interval (CI) was not estimable due to less number of participants with overall objective tumor response.
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- NA
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Duration of tumor response was defined as the time (in months) from date of first response (CR or PR) until date of first documentation of tumor progression or death, whichever occurs first. As per RECIST 1.1 CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression was defined as at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
- id
- OG000
- title
- Cabazitaxel
- description
- Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
- id
- OG001
- title
- Abiraterone Acetate or Enzalutamide
- param Type
- MEDIAN
- population Description
- Analysis was performed on subset of participants with overall objective tumor response.
- reporting Status
- POSTED
- time Frame
- From the date of the first response to the date of first documented tumor progression, or death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
- title
- Duration of Tumor Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice