NCT00499616 · OUTCOME
Definitive Determination of the Prognostic Ability of 1p and 11q
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma · Source last updated 2021-07-06
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of 3 yr EFS/OS rate
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At baseline
What was measured
Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q.
Analysis population: Eligible intermediate risk patients with 1p and 11q data.
Groups in this outcome
Group 2 (Chemotherapy, Surgery)
2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
Group 3 (Chemotherapy, Surgery)
4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 175 |
|---|
| Group 3 (Chemotherapy, Surgery) | 104 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 62 |
|---|
Reported measurements
EFS Eligible & evaluable patients without 1p loss
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 175 |
|---|
| Group 3 (Chemotherapy, Surgery) | 85 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 40 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 2 (Chemotherapy, Surgery) | 87.2 | Not reported | 82.0 | 92.4 | Not reported |
|---|
| Group 3 (Chemotherapy, Surgery) | 84.6 | Not reported | 76.8 | 92.5 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 65.4 | Not reported | 50.0 | 80.8 | Not reported |
|---|
OS Eligible & evaluable patients without 1p loss
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 175 |
|---|
| Group 3 (Chemotherapy, Surgery) | 85 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 40 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 2 (Chemotherapy, Surgery) | 99.4 | Not reported | 98.3 | 100.0 | Not reported |
|---|
| Group 3 (Chemotherapy, Surgery) | 92.8 | Not reported | 87.2 | 98.4 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 83.7 | Not reported | 71.6 | 95.8 | Not reported |
|---|
EFS Eligible & evaluable patients with 1p loss
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 0 |
|---|
| Group 3 (Chemotherapy, Surgery) | 19 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 22 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 3 (Chemotherapy, Surgery) | 94.7 | Not reported | 84.7 | 100.0 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 81.8 | Not reported | 65.2 | 98.4 | Not reported |
|---|
OS Eligible & evaluable patients with 1p loss
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 0 |
|---|
| Group 3 (Chemotherapy, Surgery) | 19 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 22 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 3 (Chemotherapy, Surgery) | 94.7 | Not reported | 84.7 | 100.0 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 95.5 | Not reported | 86.5 | 100.0 | Not reported |
|---|
EFS Eligible & evaluable patients with normal 11q
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 175 |
|---|
| Group 3 (Chemotherapy, Surgery) | 96 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 43 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 2 (Chemotherapy, Surgery) | 87.2 | Not reported | 82.0 | 92.4 | Not reported |
|---|
| Group 3 (Chemotherapy, Surgery) | 87.5 | Not reported | 80.7 | 94.2 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 73.3 | Not reported | 59.5 | 87.0 | Not reported |
|---|
OS Eligible & evaluable patients with normal 11q
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 175 |
|---|
| Group 3 (Chemotherapy, Surgery) | 96 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 43 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 2 (Chemotherapy, Surgery) | 99.4 | Not reported | 98.3 | 100.0 | Not reported |
|---|
| Group 3 (Chemotherapy, Surgery) | 93.7 | Not reported | 88.7 | 98.7 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 87.7 | Not reported | 77.4 | 98.1 | Not reported |
|---|
EFS Eligible & evaluable patients w/unbalanced 11q
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 0 |
|---|
| Group 3 (Chemotherapy, Surgery) | 8 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 18 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 3 (Chemotherapy, Surgery) | 75.0 | Not reported | 45.0 | 100.0 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 65.5 | Not reported | 42.7 | 88.2 | Not reported |
|---|
OS Eligible & evaluable patients w/unbalanced 11q
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 2 (Chemotherapy, Surgery) | 0 |
|---|
| Group 3 (Chemotherapy, Surgery) | 8 |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 18 |
|---|
Values in percentage of 3 yr EFS/OS rate · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 3 (Chemotherapy, Surgery) | 87.5 | Not reported | 64.6 | 100.0 | Not reported |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 88.2 | Not reported | 72.9 | 100.0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.0
- upper Limit
- 92.4
- value
- 87.2
- group Id
- OG001
- lower Limit
- 76.8
- upper Limit
- 92.5
- value
- 84.6
- group Id
- OG002
- lower Limit
- 50.0
- upper Limit
- 80.8
- value
- 65.4
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 85
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- EFS Eligible & evaluable patients without 1p loss
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.3
- upper Limit
- 100.0
- value
- 99.4
- group Id
- OG001
- lower Limit
- 87.2
- upper Limit
- 98.4
- value
- 92.8
- group Id
- OG002
- lower Limit
- 71.6
- upper Limit
- 95.8
- value
- 83.7
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 85
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- OS Eligible & evaluable patients without 1p loss
- categories
- measurements
- group Id
- OG001
- lower Limit
- 84.7
- upper Limit
- 100.0
- value
- 94.7
- group Id
- OG002
- lower Limit
- 65.2
- upper Limit
- 98.4
- value
- 81.8
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- EFS Eligible & evaluable patients with 1p loss
- categories
- measurements
- group Id
- OG001
- lower Limit
- 84.7
- upper Limit
- 100.0
- value
- 94.7
- group Id
- OG002
- lower Limit
- 86.5
- upper Limit
- 100.0
- value
- 95.5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- OS Eligible & evaluable patients with 1p loss
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.0
- upper Limit
- 92.4
- value
- 87.2
- group Id
- OG001
- lower Limit
- 80.7
- upper Limit
- 94.2
- value
- 87.5
- group Id
- OG002
- lower Limit
- 59.5
- upper Limit
- 87.0
- value
- 73.3
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 96
- group Id
- OG002
- value
- 43
- units
- Participants
- title
- EFS Eligible & evaluable patients with normal 11q
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.3
- upper Limit
- 100.0
- value
- 99.4
- group Id
- OG001
- lower Limit
- 88.7
- upper Limit
- 98.7
- value
- 93.7
- group Id
- OG002
- lower Limit
- 77.4
- upper Limit
- 98.1
- value
- 87.7
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 96
- group Id
- OG002
- value
- 43
- units
- Participants
- title
- OS Eligible & evaluable patients with normal 11q
- categories
- measurements
- group Id
- OG001
- lower Limit
- 45.0
- upper Limit
- 100.0
- value
- 75.0
- group Id
- OG002
- lower Limit
- 42.7
- upper Limit
- 88.2
- value
- 65.5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 18
- units
- Participants
- title
- EFS Eligible & evaluable patients w/unbalanced 11q
- categories
- measurements
- group Id
- OG001
- lower Limit
- 64.6
- upper Limit
- 100.0
- value
- 87.5
- group Id
- OG002
- lower Limit
- 72.9
- upper Limit
- 100.0
- value
- 88.2
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 18
- units
- Participants
- title
- OS Eligible & evaluable patients w/unbalanced 11q
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 104
- group Id
- OG002
- value
- 62
- units
- Participants
- description
- Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
- id
- OG000
- title
- Group 2 (Chemotherapy, Surgery)
- description
- 4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
- id
- OG001
- title
- Group 3 (Chemotherapy, Surgery)
- description
- 8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
- id
- OG002
- title
- Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
- param Type
- NUMBER
- population Description
- Eligible intermediate risk patients with 1p and 11q data.
- reporting Status
- POSTED
- time Frame
- At baseline
- title
- Definitive Determination of the Prognostic Ability of 1p and 11q
- type
- PRIMARY
- unit Of Measure
- percentage of 3 yr EFS/OS rate
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