Dr. John Raemaekers of the Radboud University Medical Center Nijmegen and the Rijnstate Hospital Arnhem, The Netherlands, and EORTC principal study coordinator on behalf of the EORTC/LYSA/FIL Intergroup H10 team says, "Even though the prognosis for patients with stage I/II HL is excellent if they are treated with the standard regimen of chemotherapy combined with radiotherapy, tumor control could still be improved for specific subgroups of patients, and late toxicity could be reduced for others. This trial, therefore, addressed two questions. First, can the outcome for early FDG-PET-positive patients with stages I/II Hodgkin lymphoma be improved by administering early intensification of chemotherapy? Second, can involved-node radiotherapy be omitted from the standard combined modality treatment in early PET-negative patients?"
This intergroup trial demonstrated that patients with stage I/II Hodgkin Lymphoma, who are still FDG-PET positive after two cycles of ABVD chemotherapy, significantly benefit in terms of progression free survival from intensification to BEACOPPesc chemotherapy followed by involved-node radiotherapy compared to patients who continue standard ABVD chemotherapy followed by involved-node radiotherapy (5yr progression-free survival rates 91% versus 77%, HR=0.42, 95%CI:0.23 to 0.74, p=0.002, with a difference of 13%, 95%CI:5% to 21%). The analysis of the early PET negative group confirmed the conclusions of the previously published interim analysis. We could not demonstrate that treatment with chemotherapy only is non-inferior to the standard combined modality treatment in terms of progression free survival.