TriangleNCT00085202 · OUTCOME
Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- probability of PFS at 2 years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2 years after tumor cell analysis in 122 participants
What was measured
The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
Analysis population: Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.
Groups in this outcome
Overall Study
Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
Average-Risk Group
Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \<1.5 cm\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \<1.5 cm\^2).
High-Risk Group
Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\^2) at the primary site after surgery.
| Group | Source count |
|---|---|
| Overall Study | 122 |
| Average-Risk Group | 85 |
| High-Risk Group | 37 |
Reported measurements
Positive ERBB2
| Group | Source count |
|---|---|
| Overall Study | 77 |
| Average-Risk Group | 54 |
| High-Risk Group | 23 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Overall Study | 79.2 | Not reported | 70.4 | 88.0 | Not reported |
| Average-Risk Group | 83.3 | Not reported | 73.5 | 93.1 | Not reported |
| High-Risk Group | 69.6 | Not reported | 50.8 | 88.4 | Not reported |
Negative ERBB2
| Group | Source count |
|---|---|
| Overall Study | 45 |
| Average-Risk Group | 31 |
| High-Risk Group | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Overall Study | 86.7 | Not reported | 76.9 | 96.5 | Not reported |
| Average-Risk Group | 93.5 | Not reported | 85.1 | 100 | Not reported |
| High-Risk Group | 71.4 | Not reported | 48.9 | 93.9 | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.8001
- statistical Method
- Log Rank
- ci Pct Value
- 95
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.5195
- statistical Method
- Log Rank
- ci Pct Value
- 95
- group Ids
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7696
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.8001
- statistical Method
- Log Rank
- ci Pct Value
- 95
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.5195
- statistical Method
- Log Rank
- ci Pct Value
- 95
- group Ids
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7696
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70.4
- upper Limit
- 88.0
- value
- 79.2
- group Id
- OG001
- lower Limit
- 73.5
- upper Limit
- 93.1
- value
- 83.3
- group Id
- OG002
- lower Limit
- 50.8
- upper Limit
- 88.4
- value
- 69.6
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Positive ERBB2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 76.9
- upper Limit
- 96.5
- value
- 86.7
- group Id
- OG001
- lower Limit
- 85.1
- upper Limit
- 100
- value
- 93.5
- group Id
- OG002
- lower Limit
- 48.9
- upper Limit
- 93.9
- value
- 71.4
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- Negative ERBB2
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 85
- group Id
- OG002
- value
- 37
- units
- Participants
- description
- The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
- id
- OG000
- title
- Overall Study
- description
- Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \<1.5 cm\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \<1.5 cm\^2).
- id
- OG001
- title
- Average-Risk Group
- description
- Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\^2) at the primary site after surgery.
- id
- OG002
- title
- High-Risk Group
- param Type
- NUMBER
- population Description
- Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.
- reporting Status
- POSTED
- time Frame
- 2 years after tumor cell analysis in 122 participants
- title
- Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors
- type
- PRIMARY
- unit Of Measure
- probability of PFS at 2 years
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Preserved source evidence · Not medical advice