According to a recent study, provisional analysis of the intergroup EORTC-LYSA-FIL 20051 H10 trial published in the Journal of Clinical Oncology points to an increased risk of early relapse when eliminating radiotherapy in early PET scan negative patients with stage I/II Hodgkin's lymphoma. Early outcome, however, was superb in both arms, and the final analysis should determine whether these preliminary findings are in fact sustained over time.
"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," said Dr. J.M.M. Raemaekers of the Radboud university medical center Nijmegen, The Netherlands, and central coordinator of the study.
The prime objective of the H10 trial was to assess whether involved-node radiotherapy could be omitted without loss of effectiveness in relation to progression-free survival in patients with stage I/II Hodgkin's Lymphoma who had a negative early PET scan following two cycles of ABVD chemotherapy.
This short-term trial analysis included a total of 1137 patients with untreated clinical stage I/II Hodgkin's Lymphoma. From these, 444 patients had favorable, while 693 patients had unfavorable diagnoses. Patients in each diagnostic group were randomized between standard and experimental treatment and first received two cycles of ABVD chemotherapy. Patients in the experimental arm who achieved a negative early PET scan following the two cycles of ABVD chemotherapy were spared involved-node radiotherapy.
For patients with a favorable prognosis and a negative early PET scan, one progression took place in the standard arm and nine progressions took place in the experimental arm. For patients with unfavorable prognosis and a negative early PET scan, seven sequences took place in the standard arm and 16 events occurred in the experimental arm. Even though there were few events and the average follow-up time short, the Independent Data Monitoring Committee determined it was unlikely that the final results would reveal non-inferiority for the experimental treatment. They, therefore, advised that randomization should be stopped for early PET negative patients.
The study was closed for recruitment in June 2011 with a total of 1952 patients.