P9641
Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study
Phase 3N = 915NCT00003119
- Population
- Patients with low-risk neuroblastoma, including asymptomatic INSS stage 2a or 2b disease (primary objective), stage 1 and stage 4s disease, and patients who required chemotherapy by protocol criteria
- Design
- Children's Oncology Group study P9641 (registry: phase 3, intergroup POG/CCG; abstract does not state a phase). Maximally safe resection of tumour; chemotherapy reserved for patients with or at risk for symptomatic disease, with less than 50% tumour resection at diagnosis, or with unresectable progressive disease after surgery alone. Primary objective: 3-year overall survival of at least 95% for patients with asymptomatic INSS stage 2a or 2b disease. 915 eligible patients in the paper (registry record NCT00003119: enrolment 968, actual).
- Primary endpoint
- OS
- Arms
- Surgery alone with restricted chemotherapy (experimental, n = 915): Maximally safe resection; chemotherapy only for protocol-defined criteria
- People
- Strother DR, Children's Oncology Group
Show the numbers
| Endpoint | Analysis | Surgery alone with restricted chemotherapy | Control | Effect |
|---|---|---|---|---|
| OSAll 915 eligible patients | finalStrother 2012 | 97% at 5 y | — | Reported in the abstract as 97% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. |
| EFSAll 915 eligible patients | finalStrother 2012 | 89% at 5 y | — | Reported in the abstract as 89% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. |
| OSPatients with asymptomatic INSS stage 2a or 2b disease | finalStrother 2012 | 96% at 5 y | — | Reported in the abstract as 96% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. This is the population of the primary objective (3-year OS of at least 95% in asymptomatic stage 2a or 2b disease), but the abstract reports 5-year values, so the analysis is labelled final rather than primary. |
| EFSPatients with asymptomatic INSS stage 2a or 2b disease | finalStrother 2012 | 87% at 5 y | — | Reported in the abstract as 87% ± 2% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The primary objective concerned 3-year OS; the abstract reports 5-year values. |
| OSPatients with INSS stage 1 disease | finalStrother 2012 | 99% at 5 y | — | Reported in the abstract as 99% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The abstract describes this group as a secondary objective. |
| OSPatients with INSS stage 4s disease | finalStrother 2012 | 91% at 5 y | — | Reported in the abstract as 91% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The abstract describes this group as a secondary objective. |
| OSPatients who required chemotherapy at diagnosis | finalStrother 2012 | 98% at 5 y | — | Reported in the abstract as 98% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The abstract describes this group as a secondary objective. |
| Endpoint | Analysis | Surgery alone with restricted chemotherapy | Control | Effect |
|---|---|---|---|---|
| OSAll 915 eligible patients | finalStrother 2012 | 97% at 5 y | — | Reported in the abstract as 97% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. |
| EFSAll 915 eligible patients | finalStrother 2012 | 89% at 5 y | — | Reported in the abstract as 89% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. |
| OSPatients with asymptomatic INSS stage 2a or 2b disease | finalStrother 2012 | 96% at 5 y | — | Reported in the abstract as 96% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. This is the population of the primary objective (3-year OS of at least 95% in asymptomatic stage 2a or 2b disease), but the abstract reports 5-year values, so the analysis is labelled final rather than primary. |
| EFSPatients with asymptomatic INSS stage 2a or 2b disease | finalStrother 2012 | 87% at 5 y | — | Reported in the abstract as 87% ± 2% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The primary objective concerned 3-year OS; the abstract reports 5-year values. |
| OSPatients with INSS stage 1 disease | finalStrother 2012 | 99% at 5 y | — | Reported in the abstract as 99% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The abstract describes this group as a secondary objective. |
| OSPatients with INSS stage 4s disease | finalStrother 2012 | 91% at 5 y | — | Reported in the abstract as 91% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The abstract describes this group as a secondary objective. |
| OSPatients who required chemotherapy at diagnosis | finalStrother 2012 | 98% at 5 y | — | Reported in the abstract as 98% ± 1% (the abstract does not state whether the value after the plus-minus sign is a standard error or another measure of spread); no confidence interval is given. The abstract describes this group as a secondary objective. |