ACNS0121
ACNS0121 showed that focused radiotherapy to the tumour bed straight after surgery cures most children with ependymoma, including those under three who used to be denied radiotherapy, and that children whose tumour could not be fully removed do far worse even with chemotherapy and a second operation.
Overview
ACNS0121 was a Children's Oncology Group phase 2 trial of 378 children with newly diagnosed ependymoma, assigned by extent of resection and histology. Children with completely resected, differentiated supratentorial tumours were observed; those with near-total or gross-total resection received immediate post-operative conformal radiotherapy to 59.4 Gy (54 Gy under 18 months); those with subtotal resection received chemotherapy (vincristine, carboplatin, cyclophosphamide, etoposide) before second-look surgery and radiotherapy. The primary endpoint was event-free survival.
Five-year event-free survival was 68.5 percent after immediate conformal radiotherapy, 61.4 percent in the observation group and 37.2 percent after subtotal resection. Outcomes were similar for children under three, tumour grade mattered, and 1q gain in posterior fossa tumours predicted relapse (five-year event-free survival 47.4 against 82.8 percent). The corpus's ependymoma page describes maximal resection followed by conformal or proton radiotherapy to the tumour bed as the ACNS0121 approach.
- 68.5 vs 61.4 out of 100 free of a major event at 5 years with Near-total or gross-total resection then immediate conformal radiotherapy compared with Observation after complete resection of differentiated supratentorial ependymoma; 7.1 more per 100.
- Roughly one extra person helped for every 14 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Subtotal resection: chemotherapy, second surgery, radiotherapy 37.2 of 100.
- 82.8 vs 47.4 out of 100 free of a major event at 5 years with Without 1q gain compared with With 1q gain; 35.4 more per 100.
- Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.0013) 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: Newly diagnosed localised ependymoma in children aged 1 to 21: observation after complete resection of differentiated supratentorial tumours, immediate conformal radiotherapy after near-total or gross-total resection, and chemotherapy before second surgery and radiotherapy after subtotal resection. 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.
378 enrolled.
95% CI 62.8 to 74.2 · 95% CI 34.5 to 89.6 · 95% CI 24.8 to 49.6
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 5 years by treatment groupprimary | Near-total or gross-total resection then immediate conformal radiotherapy | - | 68.5% | - | - | link |
| Observation after complete resection of differentiated supratentorial ependymoma | - | 61.4% | ||||
| Subtotal resection: chemotherapy, second surgery, radiotherapy | - | 37.2% | ||||
| Event-free survival at 5 years, infratentorial tumours by 1q status | Without 1q gain | - | 82.8% | - | 0.0013 | link |
| With 1q gain | - | 47.4% |
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