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A risk-adapted Wilms tumour trial: children whose lung metastases vanished after six weeks of chemotherapy were spared lung radiation, while those with stubborn nodules or a high-risk chromosome pattern got stronger chemotherapy and did better than in the past.
Single-arm, biology- and response-adapted phase 3 (Dix et al., JCO 2018 and 2019). Among 292 assessable patients with lung metastases, 133 had complete lung nodule response after six weeks of vincristine, dactinomycin and doxorubicin (DD4A) and continued without lung radiotherapy: 4-year EFS 79.5% with excellent overall survival, though events exceeded expectation. The 159 with incomplete response, or LOH at 1p/16q, received lung radiotherapy plus four cycles of cyclophosphamide and etoposide (Regimen M): 4-year EFS 88.5%, better than the 75% target. Overall 4-year EFS and OS were 85.4% and 95.6% versus 72.5% and 84.0% in the predecessor NWTS-5. Companion analysis of patients with 1p/16q LOH showed 4-year EFS of 87.3% (stage I-II, AREN0532) and 90.2% (stage III-IV, AREN0533), improved from 68.8% and 61.3% in NWTS-5. Together with AREN0532, it made molecular and response-based risk stratification the North American Wilms standard, mirroring the SIOP approach in Europe.
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.
395 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 4-year event-free survival (all lung-metastasis patients)primary | AREN0533 risk-adapted | 292 | 85.4% | - | <0.001 | link |
| NWTS-5 (historical) | - | 72.5% | ||||
| 4-year event-free survival, LOH 1p/16q stage III-IV, Regimen M | AREN0533 Regimen M | 51 | 90.2% | - | - | link |
| NWTS-5 (historical) | - | 61.3% |
One trial page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
One trial page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
Shares De-escalation, escalation and response-adapted therapy, Childhood Cancer Survivor Study (CCSS), Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG) and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Vincristine, Etoposide and the tag paediatric.
Shares Wilms tumour (nephroblastoma), Children's Oncology Group (COG), Vincristine, Doxorubicin and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Etoposide, Doxorubicin and the tag paediatric.
Shares Dactinomycin (actinomycin D), Wilms tumour (nephroblastoma), Children's Oncology Group (COG), Vincristine and the tag paediatric.
Shares Dactinomycin (actinomycin D), Wilms tumour (nephroblastoma), Children's Oncology Group (COG), Vincristine.
Shares Childhood Cancer Survivor Study (CCSS), Wilms tumour (nephroblastoma), Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Late effects and survivorship toxicity and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first and the tag paediatric.