Sure traits could assist predict which sufferers with polycythemia vera usually tend to expertise illness development, in accordance with the REVEAL research, which was offered on the 2024 European Hematology Affiliation Congress.
Knowledge from the potential section 4 trial had been offered by Dr. Michael R. Grunwald, chief of the Leukemia Division at Atrium Well being’s Levine Most cancers Institute and director of the Transplantation and Mobile Remedy Program at Levine Most cancers Institute in Charlotte, North Carolina.
Examine Highlights:
- A research known as REVEAL examined information from over 2,000 sufferers with polycythemia vera.
- The research checked out elements that may assist predict which sufferers usually tend to expertise illness development.
- 5 elements had been recognized as potential predictors of illness development: illness period, historical past of blood clot occasions, excessive white blood cell rely, low hematocrit stage and a genetic mutation.
- Of those elements, excessive white blood cell rely and genetic mutations had been essentially the most constant predictors of illness development.
- The research means that these elements could possibly be used to assist docs resolve on the perfect course of therapy for sufferers with polycythemia vera.
“5 predictors of [polycythemia vera] development had been recognized: illness period, thrombotic occasion (also called blood clot) historical past, [white blood cell count] rely of larger than 11 × 109/L, hematocrit [HCT] stage of 0.45 liters of cells per liter of blood (L/L) or decrease, and [variant allele frequency]. Nevertheless, HCT [level] of 0.45 L/L or decrease could also be confounded by illness period and cytoreductive therapy covariates. These outcomes present extra assist for using illness period and elevated WBC and VAF as danger elements for illness development and determine historical past of TEs as a possible novel danger issue,” Grunwald and coauthors wrote in a poster presentation of the findings.
At a median follow-up of three.7 years, findings from REVEAL, which included 2,023 sufferers with polycythemia vera, confirmed that 6.7% of sufferers progressed to myelofibrosis (MF). Outcomes from an evaluation of 1 issue of sufferers with versus with out development revealed that important variables consisted of time from polycythemia vera analysis to review enrollment, historical past of thrombotic occasions, HCT ranges of 0.45 L/L or decrease and white blood cell (WBC) rely of larger than 11 × 109/L at enrollment.
Investigators famous that these variables remained important in an evaluation that thought-about a number of variables, together with time from PV analysis to enrollment, historical past of thrombotic occasions, HCT ranges and WBC rely.
“At enrollment, sufferers with HCT at or lower than 0.45 L/L versus >0.45 L/L had a considerably longer period from [polycythemia vera] analysis, had increased [polycythemia vera] danger, and had been extra more likely to be receiving hydroxyurea or different cytoreductive therapy, which probably confounds the HCT at or below 0.45 L/L covariate. These confounders weren’t noticed in sufferers with WBC larger than 11×109/L versus at or lower than 11×109/L, illness period, [thrombotic event] historical past, WBC rely of larger than 11 × 109/L, HCT of 0.45 L/L or decrease, and VAF,” Grunwald and coauthors famous.
The actual-world, multicenter, REVEAL research examined information from sufferers handled in US group and tutorial facilities between 2014 and 2019. Of the two,510 sufferers included within the research, 2023 acquired a confirmed polycythemia vera analysis; of those sufferers, 1,524 had JAK2 p. V617F-positive illness, 365 had a doctor-reported JAK2 mutation and 134 had polycythemia vera confirmed by bone marrow aspirate/biopsy.
Amongst all sufferers with a confirmed analysis of polycythemia vera, the median age at enrollment was 68.0 years (vary, 22 to 95); most sufferers had been male (51.2%), White (89.1%), and handled in a group apply setting (82.6%). Sufferers who skilled illness development (135 sufferers) skilled a median time from analysis to enrollment of seven.2 years (vary, 0.0 to 34.1) and the median follow-up for these sufferers was 3.4 years (vary, 0.0 to 4.9). Sufferers who didn’t expertise illness development (1,888 sufferers) had a median time from analysis to enrollment of three.7 years (vary, 0.0 to 38.5) and the median follow-up for these sufferers was 3.7 years (vary, 0.0 to five.0).
Amongst sufferers with illness development versus with out, polycythemia vera danger at enrollment was excessive within the majority of sufferers (85.9% versus 78.7%). Polycythemia vera remedies acquired at enrollment had been watchful ready (6.7% versus 5.5%), phlebotomy (blood draw; 17.8% versus 27.8%), hydroxyurea (oral therapy for WBC; 38.5% versus 31.1%), hydroxyurea plus phlebotomy (17.8% versus 27.3%) or different (19.3% versus 8.4%), respectively. Additional, 29.6% versus 19.7% of sufferers had a historical past of thrombotic occasions at enrollment, respectively.
Extra findings from a subset evaluation revealed that of sufferers with quantitative allele burden information obtainable, VAF was a major covariate, and variant allele frequency remained a major covariate in multivariate analyses with a stepwise mannequin. WBC rely was excluded from the multivariate evaluation fashions as a result of variant allele frequency and WBC rely of larger than 11 versus lower than or equal to 11 × 109/L are confounded variables.
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