PS1504 ASSESSMENT OF HM‐PRO ITALIAN VERSION IN PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES IN CLINICAL PRACTICE
Authors: Oliva E. , Cufari P. , Andriani A. , Stelitano C. , Frongia S. , Alati C. , Martini V. , Gangemi D. , Rodà F. , Montechiarello E. , Greve B. , Praticò G. , Salek S. , Ionova T. , Martino B. 
Published: June 2019

Background:

HM‐PRO is a novel tool for the evaluation of patient reported outcomes (PROs) in haematological malignancies (HMs) created and validated according to FDA and ISPOR guidelines. It has been recently translated into several international languages. It consists of two scales: Part A which measures the impact on patients’ quality of life (QoL) and Part B which measures the effect of signs and symptoms experienced by the patients.

Aims:

The present study aims at evaluating the clinical correlates of HM‐PRO Italian version scores in clinical practice.

Methods:

Two hundred patients with HMs followed in 2 Italian centres will complete the HM‐PRO after having signed informed consent. Demographics and disease characteristics are being collected. Higher scores represent the perception of higher negative impact of disease and/or treatment and symptoms.

Results:

At present, 49 patients (36 males) of mean age 65 (SD 12) years have been included. Twenty‐two were outpatient ambulatory patients, 10 were being treated in the Day Hospital and 17 were hospitalised. They were suffering from HM for a median of 1.3, interquartile range (IQR) 0.3 – 5.6 years. Diagnoses were: 15 acute myeloid leukemia (all undergoing active treatment), 12 myelodysplastic syndrome (MDS), 7 aggressive Non Hodgkin Lyphoma (NHL), 4 acute lymphoblastic leukemia, 3 non aggressive NHL, 3 multiple myeloma, 2 aplastic anemia, 1 MDS/myeloproliferative neoplasm, 1 chronic lymphocytic leukemia. Sixteen were in remission, 17 in stable disease not in remission and 16 in progressive disease. Thirty‐five patients were receiving treatment for their HM. Mean haemoglobin was 10.6 (SD 2.5) g/dL, PLT 137 (SD 107) Gi/L, and 20% of patients had severe anemia, neutropenia and thrombocytopenia requiring red blood cell transfusions (N = 16) and platelet (PLT) transfusions (N = 12). Standardized Chronbach Alpha was 0.86 for physical behaviour (PB), 0.63 for social wellbeing (SW), 0.82 for emotional behaviour (EB), 0.75 for Eating and Drinking impact (ED), 0.73 for symptoms score (SS). Median scores were: PB 29 (IQR 11–77), SW 17 (IQR 0–50), EB 27 (IQR 14–45), ED 25 (IQR 0–75), SS 22 (IQR 13–35). Age correlated with PB (r = 0.389, p = 0.006) and SW (r = 0.497, p < 0.0001). The time from diagnosis correlated with ED (r = −0.326, p = 0.022) and SS (r = −0.293, p = 0.041). Median EB score was significantly better in patients in remission (14, IQR 5–27) than those that were stable (37, IQR 15–55) or in progression/recurrence (30, IQR 19–46, p = 0.021). However, in the 19 patients with acute leukemia, PB, EB and SS scores were significantly worse in patients that were in remission or stable versus those resistant/refractory. Patients on active treatment perceived a significant impact on ED, scoring a median of 50 (IQR range 0–75) versus 0 (IQR 0–25) in patients off treatment (p = 0.004). Hb values correlated with PB (r‐0.369, p = 0.009) and ED (r −0.401, p = 0.004); PLT counts with PB (r‐0.397, p = 0.005), SW (r −0.377, p = 0.008) and SS (r −0.326, p = 0.022); and absolute neutrophil counts with PB (r‐0.373, p = 0.008).

Summary/Conclusion:

HM‐PRO is a valid instrument to capture PROs in patients with HMs. Disease status, treatment and peripheral blood counts are associated with health‐related QoL and symptoms. The present study will provide further insight in the impact of the different HMs ‐ their state and treatment – on patients’ lives.