Redefining End Points in Myelofibrosis Clinical Trials
Автор: Blood Cancers Today
Загружено: 2025-12-03
Просмотров: 38
Based on FDA feedback, Total Symptom Score reduction of 50% (TSSS50) as an end point was replaced with Absolute Total Symptom Score in the SENTRY trial of selinexor in myelofibrosis. Prithviraj Bose, MD, of the University of Texas MD Anderson Cancer Center, discussed the significance of this change and the differences between these two clinical end points.
“If you look at the proportion [of patients] who get a 50% reduction, that, in theory, could be a very low value to start with that goes down by 50%,” Dr. Bose explained. “It doesn't tell you necessarily the magnitude of benefit that the individual patient is experiencing, because it's just the proportion that gets a halving or better of their symptom burden.”
In contrast, Absolute Total Symptom Score measures the average improvement in symptom scores between baseline and week 24.
“That seems to have more of a meaningful impact in how much the symptoms are actually going down, which intuitively tells us more about how much better patients are feeling,” Dr. Bose said.
Blood Cancers Today was developed to reach all professionals in the hematology/oncology universe, covering the latest news and analysis in leukemia, lymphoma, myeloma, myeloproliferative neoplasms, and other hematologic malignancies.
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