Multicentre clinical study with early treatment intensification in patients with high-risk Hodgkin lymphoma, identified as FDG-PET scan positive after two conventional ABVD courses
Introduction. The chemotherapy regimen ABVD is still considered the “gold standard” treatment for Hodgkin’s disease in advanced stage (HD). However, a substantial fraction of patients (30-35%) is unable to reach a long-term disease management both for resistant and recurrent diseases. The use of more intensive regimens, such as the BEACOPP, showed a superior control of the disease. In addition, it is well known that one interim FDG-PET early performed during treatment in Hodgkin’s lymphoma is an important prognostic factor.
Aims. The main goal is to assess whether early intensification of chemotherapy, based on the evaluation of chemosensitivity via FDG-PET scan after two cycles of ABVD, could improve treatment efficacy in patients with advanced stage of Hodgkin’s lymphoma. This assessment is based on the 3-y progression-free survival (PFS) of the entire cohort of patients enrolled in the study. The secondary endpoint is the feasibility of the disease management strategy for the entire patient population and for subgroups of patients with advanced stage.
Type of study. Phase II, multicenter study
Population. 780 patients with newly diagnosed HD (stages IIB-IVB) after two cycles of treatment with ABVD standard, underwent a PET: those with a positive scan were assigned to a more aggressive chemotherapy (randomized to BEACOPP or Rituximab-BEACOPP); those with a negative scan continued standard therapy (4 ABVD). The role of radiation therapy on bulky injury was assessed only in patients with negative PET2, both after the first 2 cycles and at the end of the ABVD scheme. Patients with positive PET final were assigned to a second-line therapy.
Centers. 26 Italian centers + 1 Israeli center
Promoter. GITIL (Gruppo Italiano Terapie Innovative dei Linfomi), Italy
Status. Study completed