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People whose scan was clear after two rounds of the most intensive Hodgkin chemotherapy could stop after four rounds instead of six or eight, with the same disease control and far fewer severe infections.
Escalated BEACOPP controls advanced Hodgkin lymphoma better than ABVD and costs more in infections, organ damage, second leukaemias and infertility. HD18 asked whether the scan after two cycles could be used to give more to the people who need it and less to those who do not. 2,101 patients aged 18 to 60 were recruited at 301 sites in Germany, Switzerland, Austria, the Netherlands and the Czech Republic, and randomised by their scan result.
In the scan-positive cohort, adding rituximab to escalated BEACOPP changed nothing: five-year progression-free survival 89.7 per cent (95 per cent confidence interval 85.4 to 94.0) with escalated BEACOPP against 88.1 per cent (83.5 to 92.7) with rituximab added (log-rank p = 0.46). In the scan-negative cohort, four cycles were non-inferior to six or eight: 92.2 per cent (89.4 to 95.0) against 90.8 per cent (87.9 to 93.7), a difference of 1.4 points (minus 2.7 to 5.4). Four cycles caused fewer severe infections (8 against 15 per cent) and fewer organ toxicities (8 against 18 per cent).
The scan-positive result is worth stating as a failure: rituximab added nothing to an already intensive regimen and the field stopped pursuing it. The scan-negative result is why four cycles became the German standard, and why HD21 could then go further and replace the bleomycin, vincristine and procarbazine of escalated BEACOPP with brentuximab vedotin and dacarbazine.
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.
1,945 randomised.
95 per cent confidence interval 89.4 to 95.0 · 87.9 to 93.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 5 years, scan-negative cohortprimary | Four cycles of escalated BEACOPP | 501 | 92.2% | - | - | link |
| Six or eight cycles of escalated BEACOPP | 504 | 90.8% | ||||
| Progression-free survival at 5 years, scan-positive cohort | Escalated BEACOPP | 217 | 89.7% | - | 0.46 | - |
| Escalated BEACOPP with rituximab | 217 | 88.1% | ||||
| Severe infections, scan-negative cohort | Four cycles of escalated BEACOPP | 498 | 8% | - | - | - |
| Six or eight cycles of escalated BEACOPP | 502 | 15% |
Confirmation, by a different route from HD18, that the interim scan can safely direct de-escalation in advanced Hodgkin lymphoma, and that most of the toxicity of escalated BEACOPP can be avoided in the 84 per cent of patients who respond early.
The basis for four cycles of escalated BEACOPP as the German standard when the interim scan is negative, and the reason rituximab was abandoned as an addition to that regimen. The authors recommend the scan-guided strategy for all patients with advanced-stage disease.
Shares RATHL, Deauville five-point scale, ABVD, BEACOPP and BrECADD (Hodgkin lymphoma regimens), Non-inferiority trial and the tag lymphoma-evidence.
Shares Deauville five-point scale, ABVD, BEACOPP and BrECADD (Hodgkin lymphoma regimens), Non-inferiority trial, Procarbazine and the tag lymphoma-evidence.
Shares Andreas Engert, Peter Borchmann, German Hodgkin Study Group, GHSG HD21 and the tag lymphoma-evidence.
Shares Andreas Engert, Peter Borchmann, German Hodgkin Study Group, Deauville five-point scale and the tag lymphoma-evidence.
Shares Andreas Engert, Peter Borchmann, German Hodgkin Study Group, Deauville five-point scale and the tag lymphoma-evidence.
Shares Non-inferiority trial, Survivorship and late effects are neglected, Prednisone, Vincristine and the tag lymphoma-evidence.
Shares Non-inferiority trial, Survivorship and late effects are neglected, Prednisone, Vincristine and the tag lymphoma-evidence.
Shares Prednisone, Vincristine, Etoposide, Rituximab and the tag lymphoma-evidence.