CCG-3891
Children's Cancer Group CCG-3891: myeloablative therapy with purged autologous bone marrow transplantation versus intensive chemotherapy, then 13-cis-retinoic acid versus no further therapy, in high-risk neuroblastoma
N = 379
- Population
- Children with high-risk neuroblastoma treated on a Children's Cancer Group study; 379 patients at the first randomisation and 258 at the second.
- Design
- Two sequential randomisations after the same initial chemotherapy: (1) myeloablative chemotherapy, total-body irradiation and purged autologous bone marrow transplantation versus three cycles of intensive chemotherapy; (2) in patients who completed cytotoxic therapy without progression, 13-cis-retinoic acid for six months versus no further therapy.
- Arms
- Myeloablative therapy with purged ABMT (experimental, n = 189): Myeloablative chemotherapy, total-body irradiation and autologous bone marrow transplantation (marrow purged of neuroblastoma cells)
- Intensive chemotherapy (control, n = 190): Three cycles of intensive chemotherapy
- 13-cis-retinoic acid (experimental, n = 130): 13-cis-retinoic acid (isotretinoin) for six months
- No further therapy (control, n = 128): No further therapy after completing cytotoxic therapy
- People
- Matthay KK, senior author Reynolds CP, Children's Cancer Group
Δ 36-month EFS+12 pointsΔ 36-month EFS+17 pointsΔ 60-month EFS+11 pointsΔ 60-month EFS+11 points
Show the numbers
| Endpoint | Analysis | Myeloablative therapy with purged ABMT / 13-cis-retinoic acid | Intensive chemotherapy / No further therapy | Effect |
|---|---|---|---|---|
| EFSPatients randomised at the first randomisation (189 vs 190)Event-free survival measured from the first randomisation | primaryMatthay 1999 | 34% at 3 y | 22% at 3 y | P=0.034Mean ± SE reported as 34±4% vs 22±4%. |
| EFSPatients randomised at the second randomisation (130 vs 128)Event-free survival measured from the second randomisation | primaryMatthay 1999 | 46% at 3 y | 29% at 3 y | P=0.027Mean ± SE reported as 46±6% vs 29±5%. The second randomisation included only patients who had completed cytotoxic therapy without progression. |
| EFSPatients randomised at the first randomisation (N = 379)Event-free survival measured from the first randomisation | long term-updateMatthay 2009 | 30% at 5 y | 19% at 5 y | P=0.04Mean ± SE reported as 30±4% vs 19±3%. |
| EFSPatients randomised at the second randomisationEvent-free survival measured from the second randomisation | long term-updateMatthay 2009 | 42% at 5 y | 31% at 5 y | Mean ± SE reported as 42±5% vs 31±5%; the abstract states the difference was higher with 13-cis-retinoic acid but not significant (no P value given). |
| Endpoint | Analysis | Myeloablative therapy with purged ABMT / 13-cis-retinoic acid | Intensive chemotherapy / No further therapy | Effect |
|---|---|---|---|---|
| EFSPatients randomised at the first randomisation (189 vs 190)Event-free survival measured from the first randomisation | primaryMatthay 1999 | 34% at 3 y | 22% at 3 y | P=0.034Mean ± SE reported as 34±4% vs 22±4%. |
| EFSPatients randomised at the second randomisation (130 vs 128)Event-free survival measured from the second randomisation | primaryMatthay 1999 | 46% at 3 y | 29% at 3 y | P=0.027Mean ± SE reported as 46±6% vs 29±5%. The second randomisation included only patients who had completed cytotoxic therapy without progression. |
| EFSPatients randomised at the first randomisation (N = 379)Event-free survival measured from the first randomisation | long term-updateMatthay 2009 | 30% at 5 y | 19% at 5 y | P=0.04Mean ± SE reported as 30±4% vs 19±3%. |
| EFSPatients randomised at the second randomisationEvent-free survival measured from the second randomisation | long term-updateMatthay 2009 | 42% at 5 y | 31% at 5 y | Mean ± SE reported as 42±5% vs 31±5%; the abstract states the difference was higher with 13-cis-retinoic acid but not significant (no P value given). |
Appears in
Sources
Matthay KK, Villablanca JG, Seeger RC, Stram DO, Harris RE, Ramsay NK, et al. Treatment of high-risk neuroblastoma with intensive chemotherapy, radiotherapy, autologous bone marrow transplantation, and 13-cis-retinoic acid. Children's Cancer Group. N Engl J Med. 1999;341(16):1165-73.
Matthay KK, Reynolds CP, Seeger RC, Shimada H, Adkins ES, Haas-Kogan D, et al. Long-term results for children with high-risk neuroblastoma treated on a randomized trial of myeloablative therapy followed by 13-cis-retinoic acid: a children's oncology group study. J Clin Oncol. 2009;27(7):1007-13.