Ocena profilu korzyści i ryzyka leczenia idelalizybem u chorych na przewlekłą białaczkę limfocytową i chłoniaki nie-Hodgkina

Idelalisib is a selective inhibitor of phosphoinositide 3-kinase d , approved in relapsed/refractory (RR) chronic lymphocytic leukemia (CLL), first line CLL with del17p/TP53 mutation in patients unsuitable for immunochemotherapy and RR follicular lymphoma (FL) in whom at least two lines of therapy have failed. Despite good clinical efficacy, the development of this drug has been hampered due to its adverse events (i.e. autoimmune reactions and life-threatening opportunistic infections). In this retrospective study, we summarise the tolerability of idelalisib therapy in a Polish population, analysing 61 patients treated with idelalisib in monotherapy or idelalisib-based combination regimens. Idelalisib treatment was feasible for the majority of patients, with upper respiratory tract infections (N = 13.21%) being the most common adverse event (AE), and pneumonia (N = 11.18%) — the most prevalent grade 3 or higher non-hematological AE. We observed two cases of pneumonitis, one case of gastroenteritis, and no cases of liver transaminases elevation (all regarded as the AEs characteristic of idelalisib). Most of the patients were treated in haematology reference centres where physicians are more accustomed to dealing with opportunistic infections. Cotrimoxazole prophylaxis was given to 20 (32.8%) patients, whereas acyclovir prophylaxis was administered in 33 (54.1%) cases. This could explain the less frequent life-threatening infections and decreased mortality rate compared to the published registration studies. Our study confirms the high clinical efficacy of idelalisib in CLL and RR FL.