Early positron emission tomography response-adapted treatment in stage I and II Hodgkin lymphoma: final results of the randomized EORTC/LYSA/FIL H10 trial

A randomised trial evaluating treatment adapted to the scan after two cycles of ABVD in previously untreated stage I and II Hodgkin lymphoma, classified by European Organisation for Research and Treatment of Cancer criteria as favourable or unfavourable. The standard arm was ABVD with involved-node radiotherapy regardless of the scan. In the experimental arm, scan-negative patients received ABVD alone, tested for non-inferiority, and scan-positive patients switched to two cycles of escalated BEACOPP with involved-node radiotherapy, tested for superiority.

Of 1,950 randomly assigned patients, 1,925 had an early scan, and 361 (18.8 per cent) were positive. In scan-positive patients, five-year progression-free survival improved from 77.4 per cent with ABVD and radiotherapy to 90.6 per cent with escalated BEACOPP and radiotherapy (hazard ratio 0.42, 95 per cent confidence interval 0.23 to 0.74, p = 0.002). In scan-negative patients, five-year progression-free survival in the favourable group was 99.0 against 87.1 per cent in favour of combined treatment (hazard ratio 15.8, 3.8 to 66.1) and in the unfavourable group 92.1 against 89.6 per cent (hazard ratio 1.45, 0.8 to 2.5); non-inferiority of ABVD alone could not be demonstrated in either group.