Final results of the randomized intergroup EORTC, LYSA (Lymphoma Study Association), FIL (Fondazione Italiana Linfomi) H10 trial presented at the 13th International Conference on Malignant Lymphoma in Lugano, Switzerland, on 19 June 2015 show that early FDG-PET ( 2-deoxy-2[F-18]fluoro-D-glucose positron emission tomography) adapted treatment improves the outcome of early FDG-PET-positive patients with stages I/II Hodgkin lymphoma.
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.
The Intergroup EORTC/LYSA/FIL H10 20051 trial included 1950 patients aged 15-70 years with previously untreated stage I/II supradiaphragmatic, classical Hodgkin Lymphoma. This trial was conducted at 158 sites located in eight countries: France, Italy, The Netherlands, Belgium, Denmark, Croatia, Slovakia and Switzerland. Support for this trial came from Fondation belge contre le Cancer (Belgium); Dutch Cancer Society (the Netherlands); Institut National du Cancer, Fondation Contre le Cancer, Assistance Publique Hôpitaux Paris, and Société Française de Medecine Nucleaire et Imagerie Moleculaire (France); Associazone Angela Serra (Italy); and Chugai Pharmaceutical (Japan).