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ANBL1221 found that adding the anti-GD2 antibody dinutuximab to irinotecan and temozolomide shrank relapsed neuroblastoma in about half of children, while adding temsirolimus almost never did, and chemo-immunotherapy became the standard salvage treatment.
ANBL1221 was a Children's Oncology Group randomised phase 2 selection trial for children with relapsed, refractory or progressive neuroblastoma. Patients received irinotecan and temozolomide with either temsirolimus or dinutuximab plus sargramostim (GM-CSF); the primary endpoint was the objective response rate over the first six cycles. After the randomised part chose dinutuximab, a further 36 patients were enrolled to that arm.
One of 18 patients responded with temsirolimus against 9 of 17 (52.9 percent) with dinutuximab; in all 53 patients treated with irinotecan, temozolomide, dinutuximab and GM-CSF the objective response rate was 41.5 percent with one-year progression-free survival of 67.9 percent and overall survival of 84.9 percent. Pain, fever and infection, neutropenia and hypokalaemia were the common grade 3 or higher toxicities. The regimen is the standard chemo-immunotherapy for relapsed neuroblastoma on the corpus's high-risk neuroblastoma page and was moved into first-line induction in ANBL17P1.
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.
73 enrolled.
95% CI 29.2 to 76.7; 4 partial and 5 complete responses · 95% CI 0.0 to 16.1
Source95% CI 28.2 to 54.8; stable disease in a further 22 of 53
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response over the first 6 cycles, randomised patientsprimary | Irinotecan + temozolomide + dinutuximab + GM-CSF | 17 | 52.9% | - | - | link |
| Irinotecan + temozolomide + temsirolimus | 18 | 5.6% | ||||
| Objective response, all patients given dinutuximab (randomised and expansion)primary | Irinotecan + temozolomide + dinutuximab + GM-CSF | 53 | 41.5% | - | - | link |
| Progression-free survival at 1 year, all dinutuximab patients | Irinotecan + temozolomide + dinutuximab + GM-CSF | 53 | 67.9% | - | - | link |
| Overall survival at 1 year, all dinutuximab patients | Irinotecan + temozolomide + dinutuximab + GM-CSF | 53 | 84.9% | - | - | link |
Confirms irinotecan-temozolomide-dinutuximab as the reference salvage regimen and motivated frontline chemo-immunotherapy trials (ANBL17P1, ANBL1531).
Chemo-immunotherapy with dinutuximab became the salvage standard for relapsed neuroblastoma and the regimen to move into first-line induction.
Shares Sargramostim, Dinutuximab (ch14.18) / dinutuximab beta, High-risk neuroblastoma, Childhood cancers (all types) and the tag soc-trials.
Shares Childhood cancers (all types), Children's Oncology Group (COG), Neuroblastoma (paediatric), Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag soc-trials.