TriangleNCT00602667 · OUTCOME
Event-free Survival (EFS) Compared to Historical Controls
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years
What was measured
EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.
Analysis population: Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.
Groups in this outcome
SJYC07 Low-risk Medulloblastoma Patients
Medulloblastoma patients \<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \[R0\])
SJYC07 Intermediate-risk Medulloblastoma Patients
SJYC07 medulloblastoma patients \<3 years of age, no evidence of metastatic disease (M0), and either R0 resection with any other medullo histology other than histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN) (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \>1 cm\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group
SJYC07 High-risk Medulloblastoma Patients
SJYC07 medulloblastoma patients \<3 years of age with evidence of metastatic disease
| Group | Source count |
|---|---|
| SJYC07 Low-risk Medulloblastoma Patients | 23 |
| SJYC07 Intermediate-risk Medulloblastoma Patients | 32 |
| SJYC07 High-risk Medulloblastoma Patients | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SJYC07 Low-risk Medulloblastoma Patients | 73.9 | Not reported | 56.5 | 91.3 | Not reported |
| SJYC07 Intermediate-risk Medulloblastoma Patients | 46.9 | Not reported | 30.2 | 63.6 | Not reported |
| SJYC07 High-risk Medulloblastoma Patients | 30.8 | Not reported | 14.1 | 47.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.23
- group Description
- The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).
- group Ids
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 4.99
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.84
- group Description
- The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).
- group Ids
- OG002
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
Complete source fields
- analyses
- ci Lower Limit
- 1.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.23
- group Description
- The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).
- group Ids
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 4.99
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.84
- group Description
- The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).
- group Ids
- OG002
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56.5
- upper Limit
- 91.3
- value
- 73.9
- group Id
- OG001
- lower Limit
- 30.2
- upper Limit
- 63.6
- value
- 46.9
- group Id
- OG002
- lower Limit
- 14.1
- upper Limit
- 47.5
- value
- 30.8
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 26
- units
- Participants
- description
- EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Medulloblastoma patients \<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \[R0\])
- id
- OG000
- title
- SJYC07 Low-risk Medulloblastoma Patients
- description
- SJYC07 medulloblastoma patients \<3 years of age, no evidence of metastatic disease (M0), and either R0 resection with any other medullo histology other than histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN) (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \>1 cm\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group
- id
- OG001
- title
- SJYC07 Intermediate-risk Medulloblastoma Patients
- description
- SJYC07 medulloblastoma patients \<3 years of age with evidence of metastatic disease
- id
- OG002
- title
- SJYC07 High-risk Medulloblastoma Patients
- param Type
- NUMBER
- population Description
- Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.
- reporting Status
- POSTED
- time Frame
- From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years
- title
- Event-free Survival (EFS) Compared to Historical Controls
- type
- SECONDARY
- unit Of Measure
- Percent probability
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Preserved source evidence · Not medical advice