Interim analysis of the intergroup EORTC-LYSA-FIL 20051 H10 trial published in the Journal of Clinical Oncology indicates an increased risk of early relapse when omitting radiotherapy in early PET scan negative patients with stage I/II Hodgkin's lymphoma. Early outcome, however, was excellent in both arms, and the final analysis should reveal whether these initial findings are maintained over time.
Dr. J.M.M. Raemaekers of the Radboud university medical center Nijmegen, The Netherlands, and central coordinator of the study says, "The standard treatment for patients with clinical stage I/II Hodgkin's Lymphoma is ABVD (adriamycin, bleomycin, vinblastin and dacarbazin) chemotherapy followed by radiotherapy. Striking the right balance between initial cure through combined modality treatment and accepting a higher risk of late complications, and a higher recurrence rate after omitting radiotherapy in subsets of patients who will subsequently need intensive salvage treatment, is a matter of unsettled debate."
The main objective of the H10 trial was to evaluate whether involved-node radiotherapy could be omitted without loss of efficacy in terms of progression-free survival in patients with stage I/II Hodgkin's Lymphoma who had a negative earlyPET scan after two cycles of ABVD chemotherapy. This interim trial analysis included a total of 1137 patients with untreated clinical stage I/II Hodgkin's Lymphoma. Of these, 444 patients had favorable and 693 unfavorable prognoses. Patients in each prognostic group were randomized between standard and experimental treatment and first received two cycles of ABVD chemotherapy. Patients in the experimental arm who attained a negative earlyPET scan after the two cycles of ABVD chemotherapy were spared involved-node radiotherapy.
For patients with a favorable prognosis and a negative earlyPET scan, one progression occurred in the standard arm and nine progressions occurred in the experimental arm. For patients with unfavorable prognosis and a negative earlyPET scan, seven events occurred in the standard arm and 16 events occurred in the experimental arm. Even though there were few events and the median follow-up time short, the Independent Data Monitoring Committee concluded it was unlikely that the final results would show non-inferiority for the experimental treatment. They, therefore, advised that randomization should be stopped for earlyPET negative patients.
The study was closed for recruitment in June 2011 with a total of 1952 patients.
The intergroup EORTC 20051 H10 trial is coordinated by the EORTC Lymphoma Group in collaboration with the LYmphoma Study Association (LYSA) and the Fondazione Italiana Linfomi (FIL). It is being conducted in 159 sites in eight countries: Belgium, Croatia, Denmark, France, Italy, Slovakia, Switzerland, and The Netherlands.
This randomized intergroup trial is supported by Fonds Cancer (FOCA), Belgium; Institut National du Cancer, France; Dutch Cancer Society, the Netherlands; Fondation contre le Cancer, France; Assistance Publique Hopitaux Paris, France; Societe Française de Medecine Nucleaire et Imagerie Moleculaire, France; Associazone Angela Serra, Italy; Chugai Pharmaceutical Co, Ltd.