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Hi, my name is Michael Grunwald. I'm a leukemia specialist at Levine Cancer Institute in Charlotte, North Carolina. I'm here at the American Society of Hematology annual meeting. I'm here to discuss my poster and title, patient reported symptom burden, and peripheral blood counts among patients with polycythemia vera and analysis from the REVEAL study.
Polycythemia vera is associated with urethral cytosis with or without thrombocytosis and leukocytosis, increased risk of thrombosis and symptoms including fatigue, early satiety and abdominal discomfort. Usually, in polycythemia vera, control of peripheral blood counts is the central part of treatment. A proportion of patients with polycythemia vera have a significant symptom burden that impairs their quality of life.
So far, there are limited data available concerning patient reported outcomes in patients with PV and the relationship between patient-reported outcomes and blood counts in these patients. The REVEAL study is an observational trial looking at more than 2500 patients with polycythemia vera.
The REVEAL study is ongoing. It's a prospective, multi-center study. Patients are greater than or equal to 18 years of age. Patients are required to have a complete blood count result within 30 days of completing their Myeloproliferative Neoplasm Symptom Assessment form, and it's important to know that in our study, a complete hematologic response is defined as having all three blood counts controlled. The hematocrit are less than or equal to 45%, white blood cell count less than or equal to 10, and platelet count less than or equal to 400.
The MPN-SAF, which is the Myeloproliferative Neoplasm Symptom Assessment Form, is a valid and concise tool that helps us assess symptom burden. Among the 2500 and 10 patients enrolled in reveal, 2307 had lab values within 30 days prior to enrollment, 1813 were a-valuable, meaning that they had a CBC within 30 days prior to completion to their at enrollment system assessment form.
Among the valuable patients, median age was 67 years. The majority of patients were male and the majority of patients were white. The median time from PV diagnosis to enrollment was 4.1 years. We looked at what treatments patients were receiving at the time of enrollment. Most patients were receiving either phlebotomy only, hydroxyurea only, or a combination of phlebotomy and hydroxyurea, as treatments to control their blood counts from polycythemia vera.
At the time of enrollment, we noted that 52.9% of patients had a hematocrit that was at the goal of less than or equal to 45%. 62.3% of patients had a white blood cell count less than or equal to 10, and 63.5% of patients had a platelet count less than or equal to 400. Of note, only 26.5% of patients had all three blood counts controlled, constituting a complete hematologic response.
We looked at patients' symptom assessment forms and how well they correlated with control of their blood counts. In patients who had all three blood counts uncontrolled, the average symptom assessment form score was 20.2. In patients who had one or more uncontrolled blood counts, the average score was 18.7. In patients who had two or more controlled blood counts, the symptom assessment form score was 18.7. In patients with all three blood values controlled, the total symptom score on average was 19.2.
Then we looked at symptom assessment form by each individual blood count, and it did not seem that there was a difference between patients who had a controlled versus uncontrolled hematocrit white blood cell count, platelet count, or we also looked at combined hematocrit and white blood cell count. It didn't seem to make a difference whether a group of patients was controlled or uncontrolled. They had similar symptom assessment form total symptom scores.
Finally we broke out four individual portions of the symptom assessment form tool, and looked at fatigue, inactivity, pruritus, and early satiety. We found that for fatigue, inactivity, and early satiety, it did not matter how well blood counts were controlled, the symptoms remained the same. For pruritus, the total number of patients experiencing itching was the same regardless of whether blood counts were controlled partially, totally, or not controlled. However, it looked like there was some benefit to patients with severe itching, because there were fewer patients with severe itching whose blood counts were well controlled versus patients with severe itching who had all three blood counts uncontrolled.
In conclusion, approximately half of the valuable patients had achieved hematocrit less than or equal to 45%, and 26.5% had achieved a complete hematologic response based on controlled hematocrit, white blood cell count, and platelet counts at the time of enrollment. With the exception of pruritus or itching, patients reported similar symptom severity regardless of blood count control, which may suggest symptom burden in patients with PV can persist, in spite of blood count control.
Finally, in conclusion of the study that highlights the importance of regular symptom assessment during the usual care of patients with PV, which is a central component of the recently-published NCCN guidelines for PV. Thank you for watching my presentation today.