Analysis of Patients with Essential Thrombocythemia or Myelofibrosis Enrolled in Clinical Trials in Academic versus Community Centers

Conference Correspondent

Multiple clinical trials are charged with the task of investigating emerging treatment options in diverse essential thrombocythemia (ET) and myelofibrosis (MF) disease settings. These trials take place in both academic and community centers. The Myelofibrosis and Essential Thrombocythemia Observational Study (MOST) trial evaluated patients with ET or MF enrolled in such studies in academic and community centers across the United States.

Investigators evaluated baseline parameters in academic centers (n = 24) compared with community centers (n = 82). Patients enrolled in the ET cohort had either high-risk (≥60 years of age and/or thromboembolic history) or low-risk disease. Patients with MF aged ≥18 to <65 years were considered harboring low-risk disease, while those aged ≥65 years, intermediate-1 risk MF. Across both the ET and MF cohorts, the mean age was significantly higher in patients enrolled at community centers (69.2 ± 12.0) versus academic centers (63.7 ± 14.4). Compared with academic centers, a higher proportion of low-risk patients were receiving anagrelide and ruxolitinib, a higher proportion of intermediate-1 risk patients were receiving hydroxyurea, and a lower proportion of low-risk and intermediate-1 risk patients were receiving interferon in community centers.

In the ET cohort, 1182 of 1237 patients were evaluable for analysis. Of evaluable patients, 273 were enrolled in an academic center (low-risk [LR], 17%; high-risk [HR], 83%) and 909 enrolled in a community center (LR, 12%; HR, 88%). In the ET cohort, significant differences were observed in race and ethnicity (both P <.01) and significantly higher proportions of patients were white (P <.05) and of Hispanic or Latino ethnicity (P <.05) in the community centers versus academic centers. Significant differences were also observed in patient education level (P <.0001) and employment status (P = .0001) between academic centers and community centers, and a significantly higher proportion of patients were retired in community centers versus academic centers (P = .0001). At enrollment, leukopenia was significantly more common in patients with ET enrolled at academic centers versus community centers (P <.01). The proportion of high-risk patients who were receiving ET-directed monotherapy were similar between academic centers and community centers.

In the MF cohort, 203 of 232 patients were evaluable for analysis. Of evaluable patients, 92 were enrolled in an academic center (LR, 50%; intermediate-1 risk, 50%) and 111 were enrolled in a community center (LR, 35%; intermediate-1 risk, 65%). A significant difference in ethnicity was observed (P <.05) with a significantly higher proportion of patients being of Hispanic or Latino ethnicity in community centers versus academic centers (P <.05). Significant differences were also observed in patient education level in academic centers versus community centers (P = .0002), and a higher proportion of patients were retired in community centers versus academic centers (P >.05). In the MF cohort, the proportion of low-risk patients receiving MF-directed monotherapy was higher in academic centers versus community centers, while this proportion was lower in intermediate-1 risk patients in academic centers versus community centers.

Current analysis of data from this large-scale retrospective study suggest older and minority patient populations being managed in community centers may represent an important population for assessment in future clinical trials that test current and novel treatments in ET and MF in the United States. Although statistically significant differences in age, ethnicity, and education level, disease features, and treatment history were observed between academic centers and community centers, the clinical significance of such differences, if any, has not been determined and requires further investigation.

Source: Lyons R, Lessen D, Fazal S, et al. Community versus academic practice in essential thrombocythemia and myelofibrosis: differences in clinical characteristics, diagnosis, treatment patterns, and symptom burden (analysis of data from the MOST study). American Society of Hematology Annual Meeting and Exposition; December 11-14, 2021. Abstract 1497.

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