Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study.

Real-world data in clinical practice are needed to confirm the efficacy and safety that ibrutinib has demonstrated in clinical trials of patients with chronic lymphocytic leukemia (CLL). We described the real-world persistence rate, patterns of use, and clinical outcomes in 309 patients with CLL receiving single-agent ibrutinib in first line (1L, n = 118), 2L (n = 127) and ≥3L (n = 64) in the prospective, real-world, Italian EVIdeNCE study. After a median follow-up of 23.9 months, 29.8% of patients discontinued ibrutinib (1L: 24.6%, 2L: 29.9%, ≥3L: 39.1%), mainly owing to adverse events (AEs)/toxicity (14.2%). The most common AEs leading to discontinuation were infections (1L, ≥3L) and cardiac events (2L). The 2-year retention rate was 70.2% in the whole cohort (1L: 75.4%, 2L: 70.1%, ≥3L: 60.9%). The 2-year PFS and OS were, respectively, 85.4% and 91.7% in 1L, 80.0% and 86.2% in 2L, and 70.1% and 80.0% in ≥3L. Cardiovascular conditions did not impact patients' clinical outcomes. The most common AEs were infections (30.7%), bleeding (12.9%), fatigue (10.0%), and neutropenia (9.7%), while grade 3-4 atrial fibrillation occurred in 3.9% of patients. No new safety signals were detected. These results strongly support ibrutinib as a valuable treatment option for CLL.

[Cancer-related fatigue in hematological cancer: hematologist's and patient's view]. / "Fatigue" e sintomi correlati in emato-oncologia: la visione dell'ematologo e del paziente.

Fatigue is a common complication in cancer patients, particularly in those receiving chemotherapy, with important negative effects on quality of life. It is not sufficiently studied, not completely understood and does not receive adequate consideration. The aim of this study is to improve knowledge on epidemiology, aetiology and treatment of fatigue in cancer patients in Italy. Answers to a questionnaire administered to 300 hematologists and a similar number of patients with hematological cancer have been evaluated. According to the opinion of hematologists and the experience of patients, fatigue is the most frequent and long-lasting symptom in patients with hematological cancer compromising their quality of life. The majority of the patients of the study group reports fatigue along the course of their disease, and this symptom is prominent in how it affects the different aspects of quality of life: their daily routine, working and social interaction according to clinicians; physical and emotional well-being according to patients. The results of the hematologist study group found anemia to be the leading cause of cancer-related fatigue. For the management of the symptom, the treatment of anemia is mainly done with transfusion and drugs, and it is advisable in the majority of the patients. There is still debate on the definition of anemia: hemoglobin (Hb) levels < 8 g/dl according to one third of the clinicians and greater values up to 10-11 g/dl for the others. According to the hematologists of the study group, a treatment for fatigue is generally recommended for the majority of the cancer patients, yet patients reported that, on the contrary, 50% of their hematologists did not suggest any specific treatment for this aim.