Carole Miller

Carole Miller, MD, director of the Cancer Institute at Ascension Saint Agnes, discusses notable factors which correlated with survival for patients with polycythemia vera (PV) in the 

While the overall survival for patients with PV is estimated to be 20 years, uncertainty remains regarding what factors that impact mortality within this patient population. To address this clinical question, an analysis was designed within the phase 4 study to examine mortality and causes of death in patients with PV.

Patients aged 18 years or older with a life expectancy below 6 months were enrolled, including those who had a history of or an active plan to proceed to allogeneic hematopoietic stem cell transplant within 3 months, and those who had a splenectomy.

 Significantly more patients who died in the study were characterized as high-risk at diagnosis. That makes sense, but it was primarily due to age. There wasn't a clear difference between the patients who died and were alive at the time about whether they had thromboembolic events prior to enrollment. Patients who died had higher symptom scores at all the different time points. Patients were screened about every 3 months.

 When you look at all points, the patients who died had worse symptoms than the patients who lived, but I guess that is expected. The patients who died in the 6 to 9 months with a longer follow up had significantly worse quality of life symptoms than the patients who remained alive during the course of the study. The things that pushed the increase in symptoms were generally fatigue, early satiety, difficulty concentrating, and unintentional weight loss. These were specific complaints related to polycythemia vera.

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Carole Miller, MD, discusses notable factors which correlated with survival for patients with polycythemia vera in the REVEAL study.

Factors Correlating With Survival in Polycythemia Vera

Carole Miller, MD, director of the Cancer Institute at Ascension Saint Agnes, discusses the overall findings from the 

REVEAL is a phase 4, multicenter, non-interventional, non-randomized, prospective, observational study which enrolled patients aged 18 years or older with polycythemia vera (PV) at both academic and community practices.

According to Miller, patients had their quality of life measured using a myeloproliferative neoplasms symptom scale during clinical visits. Patients were enrolled over a 2-year period and ended up being followed 36 months from the date of the last patient enrollment.

Of the 2510 patients included, 244 patients died during the course of the study. Findings determined survival in the low-risk patients to be excellent while high-risk patients had the worst outcomes (97%, 86%). Patients who died had higher rates of comorbid disease compared to the patients who were alive at the completion of the study. In regard to causes of death, the most common was vascular complications and 33% hematologic malignancies.

 This survival in patients who are considered low-risk was excellent at 97% in the lowest patient versus 86% in the high-risk patients. Interestingly enough, the patients who were considered high-risk at enrollment, during the study, their survival was very similar to the low-risk patients at 94%.

 The worst group of patients that were put into the high-risk group at enrollment both by age and thromboembolic events where their survival was at 2% at a median of 4 years of follow-up, which is somewhat surprising. Given that the mean age at enrollment was only about 66 years, and we followed the patients for about 5 years overall, seeing a greater than 10% mortality rate overall at 4 years was quite surprising.

Carole Miller, MD, discusses the REVEAL study which enrolled patients with polycythemia vera at both academic and community practices.

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Factors Correlating With Survival in Polycythemia Vera

Survival Based on Risk Status in Patients With Polycythemia Vera