Top Line: Does the omission of radiation for favorable Hodgkin lymphoma reduce late events while maintaining non-inferior disease outcomes?
The Study: H10 was a large randomized, non-inferiority trial that explored treatment de-intensification and intensification based on an interim PET scan for early stage Hodgkin lymphoma. Over 1900 patients with favorable or unfavorable, stage I-II HL were randomized to standard chemotherapy followed by involved nodal RT (INRT) or PET-adaptive treatment. In both arms, patients received 2 cycles of ABVD followed by a PET scan. In the standard arm, they received 1-2 additional cycles of ABVD and INRT regardless of PET findings. In the adaptive arm, those with a negative PET received 2-4 more cycles of ABVD but no INRT. Those in the adaptive arm with a positive PET received 2 cycles of escalated BEACOPP and INRT. The initial results found that 5-year PFS among PET-negative patients was not non-inferior when INRT was omitted, and PFS was superior among PET-positive patients when eBEACOPP was added. Here we have 10-year outcomes from H10. Among patients with favorable disease who had a negative PET, omitting INRT resulted in significantly worse PFS (85.4% v 98.8%). The majority (79%) of recurrences in the adaptive arm were at involved sites that were not irradiated. Furthermore, there were numerically more deaths in the ABVD-alone group. Among patients with unfavorable disease who had a negative PET, PFS outcomes were non-inferior when INRT was omitted (86.5% v 91.4%), and overall survival was virtually identical (94%). In the PET-positive group, there was still numerically improved PFS with the addition of BEACOPP (85.1% v 79.2%), but it was no longer significant. An important takeaway, given that one of the primary rationales for such trials is avoiding late radiation effects, is that there was no difference in late adverse events with or without INRT. The authors say it best. “The achievement of a negative ePET, as assessed in the H10 trial, seems not to be the ideal tool for identifying those patients who could be spared RT.”
TBL: Omitting radiation for patients with early stage HL, and especially among those with favorable disease, results in a >10% absolute detriment to PFS at 10 years without reducing the risk of late adverse events. | Federico, J Clin Oncol 2023
The Study: H10 was a large randomized, non-inferiority trial that explored treatment de-intensification and intensification based on an interim PET scan for early stage Hodgkin lymphoma. Over 1900 patients with favorable or unfavorable, stage I-II HL were randomized to standard chemotherapy followed by involved nodal RT (INRT) or PET-adaptive treatment. In both arms, patients received 2 cycles of ABVD followed by a PET scan. In the standard arm, they received 1-2 additional cycles of ABVD and INRT regardless of PET findings. In the adaptive arm, those with a negative PET received 2-4 more cycles of ABVD but no INRT. Those in the adaptive arm with a positive PET received 2 cycles of escalated BEACOPP and INRT. The initial results found that 5-year PFS among PET-negative patients was not non-inferior when INRT was omitted, and PFS was superior among PET-positive patients when eBEACOPP was added. Here we have 10-year outcomes from H10. Among patients with favorable disease who had a negative PET, omitting INRT resulted in significantly worse PFS (85.4% v 98.8%). The majority (79%) of recurrences in the adaptive arm were at involved sites that were not irradiated. Furthermore, there were numerically more deaths in the ABVD-alone group. Among patients with unfavorable disease who had a negative PET, PFS outcomes were non-inferior when INRT was omitted (86.5% v 91.4%), and overall survival was virtually identical (94%). In the PET-positive group, there was still numerically improved PFS with the addition of BEACOPP (85.1% v 79.2%), but it was no longer significant. An important takeaway, given that one of the primary rationales for such trials is avoiding late radiation effects, is that there was no difference in late adverse events with or without INRT. The authors say it best. “The achievement of a negative ePET, as assessed in the H10 trial, seems not to be the ideal tool for identifying those patients who could be spared RT.”
TBL: Omitting radiation for patients with early stage HL, and especially among those with favorable disease, results in a >10% absolute detriment to PFS at 10 years without reducing the risk of late adverse events. | Federico, J Clin Oncol 2023