Summary of findings for the main comparison. Dinutuximab‐containing immunotherapy compared to standard therapy for people with high‐risk neuroblastoma pre‐treated with autologous hematopoietic stem cell transplantation.
Dinutuximab‐containing immunotherapy compared to standard therapy for people with high‐risk neuroblastoma pre‐treated with autologous haematopoietic stem cell transplantation | ||||||
Patient or population: People with high‐risk neuroblastoma pre‐treated with autologous haematopoietic stem cell transplantation Setting: Paediatric oncology and haematology, specialised centres Intervention: Dinutuximab‐containing immunotherapy Comparison: Standard therapy | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with standard therapy | Risk with dinutuximab‐containing immunotherapy | |||||
Overall survival (reported as mortality) | 549 per 10001 | 328 per 1000 (219 to 471) | HR 0.50 (0.31 to 0.80) | 226 (1 RCT) | ⊕⊕⊕⊖ MODERATE2,3 | The follow‐up time regarding all randomised participants is unclear. Median follow‐up after randomisation in participants alive without an event was 2.0 years (5 days to 6.5 years) and 2.1 years (4 days to 6.9 years) for the dinutuximab‐containing immunotherapy arm and the standard therapy arm, respectively. |
Treatment‐related mortality ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No adequate information on this outcome was provided. Randomised data were mixed with non‐randomised data, and the randomised data were not analysed separately, so this outcome could not be assessed. |
Progression‐free survival ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No information on this outcome was provided. |
Event‐free survival (reported as relapse, progressive disease, secondary cancer, and mortality) | 717 per 10001 | 537 per 1000 (404 to 687) | HR 0.61 (0.41 to 0.92) | 226 (1 RCT) | ⊕⊕⊕⊖ MODERATE3,4 | The follow‐up time regarding all randomised participants is unclear. Median follow‐up after randomisation in participants alive without an event was 2.0 years (5 days to 6.5 years) and 2.1 years (4 days to 6.9 years) for the dinutuximab‐containing immunotherapy arm and the standard therapy arm, respectively. |
Early toxicity ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No adequate information on this outcome was provided. Randomised data were mixed with non‐randomised data, and the randomised data were not analysed separately, so this outcome could not be assessed. |
Late non‐haematological toxicity ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No information on this outcome was provided. |
Health‐related quality of life ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No information on this outcome was provided. |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; HR: hazard ratio; RCT: randomised controlled trial | ||||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. |
1The assumed risk is based on the number of events in the control group at the final time point of the survival curve presented in the included study. 2The presence of selection bias, performance bias, attrition bias, and other bias is unclear; there is a low risk of detection bias and reporting bias; we downgraded one level for study limitations. 3We did not downgrade for imprecision. The study is small but the effect is large and the confidence interval is below no effect. 4The presence of selection bias, performance bias, detection bias, attrition bias, and other bias is unclear; there is a low risk of reporting bias; we downgraded one level for study limitations.