Ибрутиниб в лечении хронического лимфолейкоза у пациентов старше 60 лет из групп высокого и очень высокого риска

Abstract

Aim. To assess the efficacy and tolerability of ibrutinib in chronic lymphocytic leukemia (CLL) therapy for high- and very-high-risk patients over 60 years of age.
 Materials & Methods. The study enrolled 18 CLL patients aged 60 and older. The patients were stratified by age: group 1 included 10 patients aged 60–70 years (median age 64.5 years) and group 2 included 8 patients aged ≥ 71 years (median age 75.8 years); there was equal number of men and women. All patients were subjected to molecular genetic analysis to identify poor prognosis factors and determine the IGHV gene mutation status. The cytogenetic analysis revealed karyotypic abnormalities including 17p deletion in 3 female patients aged 60, 66, and 77 years, respectively. All the patients had CLL without mutation in IGHV genes. They received ibrutinib 420 mg/day per os as first- and second-line therapies.
 Results. All patients showed aggravated comorbidity. The median follow-up was 28 months (range 18–42 months) in age group 1 and 46 months (range 12–78 months) in group 2. In group 1, a complete remission in 2 patients with del(17p) and a partial remission (PR) in 3 patients were achieved. PR with lymphocytosis was reported in the rest of 5 patients treated with ibrutinib for 12 months. In group 2, PR with the management of autoimmune complications in 5 out of 8 patients and PR with lymphocytosis in 3 patients were reported. The drug was well tolerated in both groups. No signs of severe hematological toxicity were observed in either of them.
 Conclusion. The choice of ibrutinib for high- and very-high-risk CLL patients aged 60 and older appeared to be optimal. This is also proved by the ease of administration of oral capsules, high efficacy, absence of tumor lysis syndrome, good tolerability, and acceptable toxicity profile.