# ANBL1221: irinotecan-temozolomide with temsirolimus or dinutuximab in relapsed or refractory neuroblastoma

Source: https://onco.cc/key-papers/paper-anbl1221-irinotecan-temozolomide-dinutuximab-mody-lancet-oncol-2017/  
OnCo record `paper-anbl1221-irinotecan-temozolomide-dinutuximab-mody-lancet-oncol-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In children whose neuroblastoma had come back, adding the anti-GD2 antibody dinutuximab to irinotecan and temozolomide shrank the cancer in half of them, while adding temsirolimus almost never did.

## Summary

Children's Oncology Group open-label randomised phase 2 selection trial: 35 eligible children with relapsed, refractory or progressive neuroblastoma were randomised to irinotecan and temozolomide with temsirolimus (n 18) or with dinutuximab plus GM-CSF (n 17).

One patient (6 percent) responded with temsirolimus against nine (53 percent, four partial and five complete responses) with dinutuximab. Pain, hypokalaemia, neutropenia, thrombocytopenia, anaemia, fever and hypoxia were the common grade 3 or worse events with dinutuximab; no deaths were attributed to treatment.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Journal: The Lancet Oncology
- Year: 2017
- DOI: 10.1016/S1470-2045(17)30355-8
- Authors: Mody R, Naranjo A, Van Ryn C, et al.
- Findings: Objective response 53 percent (95% CI 29.2 to 76.7) with irinotecan-temozolomide-dinutuximab versus 6 percent (0.0 to 16.1) with irinotecan-temozolomide-temsirolimus.; Grade 3 or worse pain in 44 percent and hypokalaemia in 38 percent of dinutuximab patients; one grade 4 hypoxia met unacceptable toxicity criteria.
- What it means: Chemo-immunotherapy with dinutuximab became the salvage standard for relapsed neuroblastoma and the regimen to move into first-line induction.
- Caveats: Small randomised selection design intended to pick an arm for further study, not to prove superiority.

## Sources

- Lancet Oncol 2017: https://doi.org/10.1016/S1470-2045(17)30355-8
- PubMed: https://pubmed.ncbi.nlm.nih.gov/28549783/

## Connected records

- cancers: [High-risk neuroblastoma](https://onco.cc/cancers/neuroblastoma-high-risk/), [Neuroblastoma (paediatric)](https://onco.cc/cancers/neuroblastoma/)
- drugs: [Dinutuximab (ch14.18) / dinutuximab beta](https://onco.cc/drugs/dinutuximab/), [Irinotecan (and liposomal irinotecan)](https://onco.cc/drugs/irinotecan/), [Temozolomide](https://onco.cc/drugs/temozolomide/), [Temsirolimus](https://onco.cc/drugs/temsirolimus/)
- trials: [ANBL1221](https://onco.cc/trials/anbl1221/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)

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