First results of the EORTC-GELA H9 randomized trials: the H9-F trial (comparing 3 radiation dose levels) and H9-U trial (comparing 3 chemotherapy schemes) in patients with favorable or unfavorable early stage Hodgkin's lymphoma (HL)

6505 Background: EORTC and GELA aim at reducing acute and late side effects of treatment in early stages HL, without jeopardizing high event-free survival (EFS) and overall survival (OS) rates already achieved. Methods: From October 1998 to May 2004, 1591 patients with stage I-II HL were enrolled into 2 trials based on 4 prognostic factors: age, symptoms, number of involved areas, MT-ratio. The H9-F trial compared 36 Gy involved field radiotherapy (IF-RT) vs 20 Gy IF-RT vs no RT in patients in complete remission (CR(u)) after 6 cycles of EBVP. The H9-U trial compared 6 cycles of ABVD vs 4 cycles of ABVD vs 4 cycles of BEACOPP baseline, followed by 30 Gy IF-RT in all arms, in patients with unfavorable clinical features. Results: In the H9-F trial, of the 783 patients enrolled, 619 (79%) achieved a CR(u) and were randomized. Inclusion of patients in the no-RT arm was stopped in May 2002, because stopping rules were met (ie. > 20% of events). Inclusion in the other 2 arms continued until May 2004. After a me...