Early PET-Negative Stage I/II Hodgkin Lymphoma Patients Show Increased Risk of Early Relapse when Radiotherapy Is Not Used

The interim analysis of the intergroup EORTC-LYSA-FIL 20051 H10 trial was published online March 17, 2014, in the Journal of Clinical Oncology. Early outcome, however, was excellent in both arms, and the final analysis should reveal whether these preliminary findings are upheld over time.

Dr. J.M.M. Raemaekers, from the Radboud University Medical Center (Nijmegen, The Netherlands), and central coordinator of the study stated, “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 early PET scan after two cycles of ABVD chemotherapy. This interim trial analysis included a total of 1,137 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 early PET scan after the two cycles of ABVD chemotherapy were spared involved-node radiotherapy.

One progression occurred in the standard arm and nine progressions occurred in the research arm, for patients with a favorable prognosis and a negative early PET scan. For patients with unfavorable prognosis and a negative early PET scan, seven events occurred in the standard arm and 16 events occurred in the research 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 noninferiority 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. 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.

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Radboud University Medical Center