TY  -  JOUR
AU  -  Falzon, Andrea
AU  -  Del Pace, Gemma
AU  -  Di Geronimo, Valeria
AU  -  Pedicelli, Maria Letizia
AU  -  Lauro, Erminia
AU  -  Muto, Fedora
AU  -  Frazzetto, Angela Maria Elena
AU  -  Cantillo, Enrica
AU  -  Silvestro, Elena
AU  -  Izzi, Chiara
AU  -  Abate, Davide Natale
AU  -  Torquati, Giancarlo
AU  -  Bianco, Ciro
AU  -  Oriolo, Carmela
AU  -  Vitiello, Antonietta
AU  -  Pennacchiotti, Chiara
AU  -  Musicco, Felice
AU  -  Pupo, Livio
AU  -  Laureana, Roberta
AU  -  Del Principe, Maria Ilaria
AU  -  Postorino, Massimiliano
AU  -  Celeste, Maria Grazia
T1  -  Safety of venetoclax in the treatment of Chronic Lymphocytic Leukemia: gender differences in real-world practice
PY  -  2024
Y1  -  2024-10-01
DO  -  10.1721/4417.44133
JO  -  Giornale Italiano di Farmacia Clinica
JA  -  GIFAC
VL  -  38
IS  -  4
SP  -  132
EP  -  139
PB  -  Il Pensiero Scientifico Editore
SN  -  1120-3749
Y2  -  2026/04/14
UR  -  http://dx.doi.org/10.1721/4417.44133
N2  -  Summary. Introduction. Chronic Lymphocytic Leukemia (CLL) is a chronic lymphoproliferative disease that predominantly affects males, typically between the ages of 70 and 79. Despite significant therapeutic advances, the main risk is that adverse reactions may negatively impact the proper home management of therapy, thus affecting adherence and persistence to treatment, and consequently, clinical outcomes. An important consideration is the underrepresentation of females in clinical trials for oncology drugs. Among the new molecules approved for CLL, venetoclax has the lowest percentage of women enrolled in registrational clinical trials. The aim of the present study is to investigate the impact of gender differences on treatment safety through an analysis of adherence and persistence to venetoclax in CLL between the two sexes. A secondary objective is to explore the reasons for non-adherence through medical records and direct consultations with department physicians. Material and methods. This is a retrospective observational study that analyzed data from AIFA monitoring registries and administrative databases. Adherence was calculated using the corrected Proportion of Days Covered (PDC) method, while persistence was assessed using a 60-day time frame to define the discontinuation event. All CLL patients treated with venetoclax at research center who had completed the ramp-up phase were considered eligible. Data were collected from the date of the first dispensation (06/02/2018) up until 01/12/2023. The total duration of the study spans from 06/02/2018 to 01/12/2023. Results. A total of 39 patients were enrolled, with a mean age of 65 years and an adherence rate to venetoclax of 0,78. In patients undergoing treatment for more than 6 months, adherence was 0,76. In both analyses, no statistically significant difference in adherence was observed between men and women (p=0,6262 and 0,3815, respectively). The same was observed in the persistence analysis (p=0,2605). Of the 3 non-adherent patients, 2 (one man and one woman) experienced severe adverse reactions that directly impacted their adherence and persistence to venetoclax. Conclusions. The results suggest a different safety profile of venetoclax between men and women. Synergy with the hospital pharmacist could improve the quality of care provided by the department, while ensuring high standards in addressing patients’ health needs. The next necessary step will be to rely on an increasing number of studies capable of measuring the level of care improvement when the pharmacological expertise of the hospital pharmacist works synergistically with that of other healthcare professionals.
ER  -