Interim analysis of an important trial looking at the value of radiotherapy in early Hodgkin's lymphoma patients suggests that not giving radiotherapy to these patients does create an increased risk of early relapse.
The intergroup EORTC-LYSA-FIL 20051 H10 trial's interim analysis results have been published in the Journal of Clinical Oncology. The primary objective of the H10 trial is to evaluate whether involved-node radiotherapy could be omitted without losing any 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.
So far, researchers have found an increased risk of early relapse when not adding radiation in those patients whose early PET scans are negative. However, early outcomes in both arms of the study were excellent, and researchers will learn whether these findings are sustained over time when the study's final analysis is done.
Prognosis, PET scan results correlate with treatment response
The interim trial analysis included 1137 patients with untreated clinical stage I/II Hodgkin's lymphoma. Of these, 444 patients had favorable and 693 unfavorable prognoses. All patients in were randomized between standard and experimental treatment and first received two cycles of ABVD combination chemotherapy. Patients in the experimental arm who attained a negative early PET scan after the two cycles of ABVD were spared involved-node radiotherapy.
For patients with a favorable prognosis and a negative early PET scan, one progression occurred in the standard arm, and nine occurred in the experimental arm.
For patients with an unfavorable prognosis and a negative early PET scan, seven events occurred in the standard arm and 16 events occurred in the experimental arm.
An Independent Data Monitoring Committee advised that randomization should be stopped for early PET negative patients.
"The standard treatment for patients with clinical stage I/II Hodgkin's Lymphoma is ABVD followed by radiotherapy," said Dr. J.M.M. Raemaekers of the Radboud university medical center Nijmegen, The Netherlands, and central coordinator of the study. "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."
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