AHOD1331
AHOD1331 showed that replacing bleomycin with the antibody-drug conjugate brentuximab vedotin in the chemotherapy given to children and teenagers with advanced Hodgkin lymphoma cut relapses by more than half without extra side effects, and it became the new standard for high-risk disease.
Overview
AHOD1331 was an open-label Children's Oncology Group phase 3 trial at 153 institutions that randomised 600 patients (587 eligible) aged 2 to 21 with previously untreated high-risk classical Hodgkin lymphoma to five 21-day cycles of brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide, or to the standard paediatric ABVE-PC regimen. Involved-site radiotherapy was given after cycle five to slow-responding lesions on central PET review and to large mediastinal disease. The primary endpoint was event-free survival.
At a median follow-up of 42.1 months three-year event-free survival was 92.1 percent with brentuximab vedotin against 82.5 percent with standard care (hazard ratio 0.41), with similar toxicity and similar use of radiotherapy (53.4 against 56.8 percent); three-year overall survival was 99.3 and 98.5 percent. Brentuximab vedotin was approved in the United States in November 2022 for paediatric high-risk classical Hodgkin lymphoma on this trial. The corpus's Hodgkin lymphoma page cites AHOD1331 for ABVE-PC with brentuximab and PET-guided radiotherapy omission.
- 92.1 vs 82.5 out of 100 free of a major event at 3 years with Brentuximab vedotin + doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide compared with ABVE-PC (standard care); 9.6 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 59 percent lower chance of the event at any given time (hazard ratio 0.41, likely range 0.25 to 0.67).
- 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.
- 99.3 vs 98.5 out of 100 alive at 3 years with Brentuximab vedotin + AVEPC compared with ABVE-PC (standard care); 0.8 more per 100.
- Roughly one extra person helped for every 125 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 53.4 vs 56.8 out of 100 reached this endpoint with Brentuximab vedotin + AVEPC compared with ABVE-PC (standard care); 3.4 fewer per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Newly diagnosed high-risk classical Hodgkin lymphoma (stage IIB with bulk, IIIB, IVA or IVB) in patients aged 2 to 21: five cycles of brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide against standard ABVE-PC, with PET-guided involved-site radiotherapy for slow-responding lesions. 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.
600 enrolled.
95% CI 88.4 to 94.7; 587 eligible of 600 randomised; median follow-up 42.1 months · 95% CI 77.4 to 86.5
Source95% CI 97.3 to 99.8 · 95% CI 96.0 to 99.4
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 3 yearsprimary | Brentuximab vedotin + doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide | - | 92.1% | 0.41 (0.25 to 0.67) | <0.001 | link |
| ABVE-PC (standard care) | - | 82.5% | ||||
| Overall survival at 3 years | Brentuximab vedotin + AVEPC | - | 99.3% | - | - | link |
| ABVE-PC (standard care) | - | 98.5% | ||||
| Patients given involved-site radiotherapy | Brentuximab vedotin + AVEPC | - | 53.4% | - | - | link |
| ABVE-PC (standard care) | - | 56.8% |
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