ANBL0531
ANBL0531 showed that children with intermediate-risk neuroblastoma can be cured almost every time with a treatment plan that gives less chemotherapy to those with favourable tumour biology and a good early response, keeping three-year survival at 95 percent while cutting treatment for many.
Overview
ANBL0531 was the Children's Oncology Group phase 3 study for intermediate-risk neuroblastoma, enrolling 464 patients (404 evaluable) between 2007 and 2011. Treatment intensity was assigned by tumour biology (histology, MYCN, ploidy, 1p and 11q status) and response, with two to eight cycles of carboplatin, etoposide, cyclophosphamide and doxorubicin, surgery when resectable, isotretinoin for the highest-risk subset, and observation alone for some infants with stage 4S disease. The primary endpoint was three-year overall survival.
Three-year event-free and overall survival were 83.2 and 94.9 percent, with overall survival of 100 percent for localised disease, despite reduced treatment for many subsets compared with earlier studies; the registry results give three-year overall survival of 99.4 percent in the lowest-intensity group and 88.4 percent in the highest. Infants with stage 4 disease and unfavourable biology did worse (three-year event-free survival 66.8 against 86.9 percent). The corpus's intermediate-risk neuroblastoma page cites ANBL0531 with A3961 for chemotherapy tailored by biology and response.
- 94.9 out of 100 people alive at 3 years with Response- and biology-based therapy.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 99.4 vs 93.5 out of 100 alive at 3 years with Group 2 (two cycles, surgery) compared with Group 3 (four cycles, surgery); 5.9 more per 100.
- Roughly one extra person helped for every 17 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Group 4 (eight cycles, surgery, isotretinoin) 88.4 of 100.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 83.2 out of 100 people free of a major event at 3 years with Response- and biology-based therapy.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 86.9 vs 66.8 out of 100 free of a major event at 3 years with Favourable biology compared with One or more unfavourable biological features; 20.1 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.02) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Intermediate-risk neuroblastoma: response- and biology-based assignment to two, four or eight cycles of carboplatin, etoposide, cyclophosphamide and doxorubicin (with topotecan for poor responders) and surgery, with isotretinoin for the highest-risk subset and no chemotherapy for some stage 4S infants. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
464 enrolled.
95% CI 92.7 to 97.2
Source95% CI 79.4 to 87.0
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 3 years, all evaluable patientsprimary | Response- and biology-based therapy | 404 | 94.9% | - | - | link |
| Event-free survival at 3 years, all evaluable patients | Response- and biology-based therapy | 404 | 83.2% | - | - | link |
| Event-free survival at 3 years, infants with stage 4 disease by biology | Favourable biology | 61 | 86.9% | - | 0.02 | link |
| One or more unfavourable biological features | 47 | 66.8% | ||||
| Overall survival at 3 years by treatment group (registry results)primary | Group 2 (two cycles, surgery) | - | 99.4% | - | - | link |
| Group 3 (four cycles, surgery) | - | 93.5% | ||||
| Group 4 (eight cycles, surgery, isotretinoin) | - | 88.4% |
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