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Omitting radiotherapy in early positron emission tomography-negative stage I/II Hodgkin lymphoma is associated with an increased risk of early relapse : Clinical results of the preplanned interim analysis of the randomized EORTC/LYSA/FIL H10 trial . PURPOSE Combined-modality treatment is standard treatment for patients with clinical stage I/II Hodgkin lymphoma ( HL ) . We hypothesized that an early positron emission tomography ( PET ) scan could be used to adapt treatment . Therefore , we started the randomized EORTC/LYSA/FIL Intergroup H10 trial evaluating whether involved-node radiotherapy ( IN-RT ) could be omitted without compromising progression-free survival in patients attaining a negative early PET scan after two cycles of ABVD ( doxorubicin , bleomycin , vinblastine , and dacarbazine ) as compared with standard combined-modality treatment . PATIENTS AND METHODS Patients age 15 to 70 years with untreated clinical stage I/II HL were eligible . Here we report the clinical outcome of the preplanned interim futility analysis scheduled to occur after documentation of 34 events in the early PET-negative group . Because testing for futility in this noninferiority trial corresponds to testing the hypothesis of no difference , a one-sided superiority test was conducted . RESULTS The analysis included 1,137 patients . In the favorable subgroup , 85.8 % had a negative early PET scan ( standard arm , one event v experimental arm , nine events ) . In the unfavorable subgroup , 74.8 % had a negative early PET scan ( standard arm , seven events v experimental arm , 16 events ) . The independent data monitoring committee concluded it was unlikely that we would show noninferiority in the final results for the experimental arm and advised stopping random assignment for early PET-negative patients . CONCLUSION On the basis of this analysis , combined-modality treatment resulted in fewer early progressions in clinical stage I/II HL , although early outcome was excellent in both arms . The final analysis will reveal whether this finding is maintained over time .
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Intervention_Pharmacological
Combined-modality treatment
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Intervention_Physical
positron emission tomography ( PET )
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Intervention_Physical
involved-node radiotherapy ( IN-RT )
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Intervention_Pharmacological
doxorubicin
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Intervention_Pharmacological
bleomycin
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Intervention_Pharmacological
vinblastine
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Intervention_Pharmacological
dacarbazine
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Intervention_Pharmacological
combined-modality treatment
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Intervention_Physical
PET scan
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Intervention_Physical
PET scan
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Intervention_Physical
PET-negative
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Outcome_Physical
clinical stage I/II HL
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Participant_Age
age 15 to 70 years
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Participant_Sample-size
1,137
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Participant_Sample-size
favorable subgroup
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Participant_Sample-size
unfavorable subgroup