PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study

A randomised non-inferiority phase 3 study at 90 centres in Belgium and France. Eligible patients were aged 16 to 60 with newly diagnosed Hodgkin lymphoma excluding the nodular lymphocyte predominant subtype, performance status under 3, and stage III, IV or IIB with a mediastinum-to-thorax ratio of 0.33 or more or extranodal localisation. All patients received two cycles of escalated BEACOPP. The standard group then completed six cycles regardless of the scan; the scan-driven group switched to four cycles of ABVD if the scan after two cycles was negative and continued escalated BEACOPP if it was positive. The non-inferiority margin was 10 percentage points.

From 19 May 2011 to 29 April 2014, 823 patients were enrolled, 413 to standard care and 410 to the scan-driven arm; 346 (84 per cent) of the scan-driven arm switched to ABVD and 51 (12 per cent) continued escalated BEACOPP. At a median follow-up of 50.4 months (interquartile range 42.9 to 59.3), five-year progression-free survival by intention to treat was 86.2 per cent (95 per cent confidence interval 81.6 to 89.8) with standard treatment and 85.7 per cent (81.4 to 89.1) with scan-driven treatment (hazard ratio 1.084, 0.737 to 1.596, p = 0.65).