I think it’s a standard, a current standard, to omit whole field radiotherapy of [inaudible] in end-of-treatment PET-negative patients. However, in aggressive non-Hodgkin lymphoma, the database for this is quite small. There were also data from the RICOVER-60 trial and in the RICOVER-60 trial bulky disease was not anymore an adverse risk factor so then there was an amendment, RICOVER-noRTh trial, no radiotherapy, and there the bulky omission, unselected omission of radiotherapy resulted in a hazard ratio of above four for PFS and OS...
I think it’s a standard, a current standard, to omit whole field radiotherapy of [inaudible] in end-of-treatment PET-negative patients. However, in aggressive non-Hodgkin lymphoma, the database for this is quite small. There were also data from the RICOVER-60 trial and in the RICOVER-60 trial bulky disease was not anymore an adverse risk factor so then there was an amendment, RICOVER-noRTh trial, no radiotherapy, and there the bulky omission, unselected omission of radiotherapy resulted in a hazard ratio of above four for PFS and OS. But both trials were without PET, so unselected omission. So there was a retrospective analysis by Ciara Freeman from British Columbia and from, I think, from 2005 to 2017, more than 700 patients and they showed that the omission of radiotherapy to bulky sites is safe for patients. And then Michael Pfreundschuh showed in 2017 the interim results of the OPTIMAL>60 less favorable trial. And he reported that the omission is safe based on the data of the interim analysis. So with the final analysis, we see that the PET-guided radiotherapy of bulky disease results in very good outcomes. Bulky disease is not anymore a risk factor but I have to add that involved-field radiotherapy was done also to external sites based on recommendation of the central trial office, so for instance skeletal lesions or testicular lesions, and then there’s one thing that there was a pre-planned comparison with the RICOVER 60 trial for the bulky patients and thus also the outcomes are equal for the bulky patients. However, if we look at the whole population of the OPTIMAL>60 less favorable patients and compare to the RICOVER 60 patients, then the whole population of the OPTIMAL 60 trial is better, has an improved outcome compared to the RICOVER 60 trial. So that’s a bit, it’s a little bit, we cannot, we cannot explain this in total. We are working on this analysis ongoing, but we think that PET-guided omission of radiotherapy to bulky sites is safe for elderly patients.
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