TriangleNCT02684058 · OUTCOME
LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria
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
- Up to approx. 3 years and up to approx 4.2 years
What was measured
Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
Analysis population: Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered with a confirmed CR or PR as per central independent review assessment using RANO criteria. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.
Groups in this outcome
LGG Cohort: Dabrafenib and Trametinib
Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
LGG Cohort: Carboplatin and Vincristine
Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.
| Group | Source count |
|---|---|
| LGG Cohort: Dabrafenib and Trametinib | 40 |
| LGG Cohort: Carboplatin and Vincristine | 6 |
Reported measurements
Up to approx. 3 years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LGG Cohort: Dabrafenib and Trametinib | 20.3 | Not reported | 12.0 | NA | Not estimable (NA) due to the insufficient number of participants with events |
| LGG Cohort: Carboplatin and Vincristine | NA | Not reported | 6.6 | NA | Not estimable (NA) due to the insufficient number of participants with events |
Up to approx 4.2 years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LGG Cohort: Dabrafenib and Trametinib | 30.0 | Not reported | 16.6 | NA | Not estimable (NA) due to the insufficient number of participants with events |
| LGG Cohort: Carboplatin and Vincristine | 19.4 | Not reported | 6.6 | NA | Not estimable (NA) due to the insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable (NA) due to the insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- NA
- value
- 20.3
- comment
- Not estimable (NA) due to the insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 6.6
- upper Limit
- NA
- value
- NA
- title
- Up to approx. 3 years
- categories
- measurements
- comment
- Not estimable (NA) due to the insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 16.6
- upper Limit
- NA
- value
- 30.0
- comment
- Not estimable (NA) due to the insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 6.6
- upper Limit
- NA
- value
- 19.4
- title
- Up to approx 4.2 years
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
- id
- OG000
- title
- LGG Cohort: Dabrafenib and Trametinib
- description
- Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.
- id
- OG001
- title
- LGG Cohort: Carboplatin and Vincristine
- param Type
- MEDIAN
- population Description
- Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered with a confirmed CR or PR as per central independent review assessment using RANO criteria. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.
- reporting Status
- POSTED
- time Frame
- Up to approx. 3 years and up to approx 4.2 years
- title
- LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice