TY  - JOUR
A1  - Hoechstetter, Manuela
A1  - Knauf, Wolfgang
A1  - Dambacher, Silvia
A1  - Hucke, Nike
A1  - Höhne, Kristin
A1  - Troostenburg, Anna van
A1  - Ramroth, Heribert
A1  - Abenhardt, Wolfgang
A1  - Rummel, Mathias
T1  - Results of a prospective non-interventional post-authorization safety study of idelalisib in Germany
T2  - Clinical Lymphoma Myeloma and Leukemia
N2  - Background: In pivotal studies, idelalisib demonstrated remarkable efficacy and manageable tolerability in patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). This prospective, multicenter, non-interventional post-authorization study assessed the characteristics, clinical management, and outcome of CLL and FL patients receiving idelalisib in routine clinical practice in Germany.
Patients: Observational study in CLL and FL patients treated with idelalisib between September 2015 and December 2020.
Results: A total of 147 patients with CLL and FL were included with a median age of 75 and 71 years, respectively. More than 80% of patients presented with comorbidity and many CLL patients with documented high-risk genetic features, including del(17p)/TP53 mutation or unmutated IGHV. The median progression-free survival (PFS) and overall survival (OS) were not reached in the CLL cohort irrespective of del(17p)/TP53 or unmutated IGHV. The estimated 6-month PFS and OS rates in CLL were 82% and 92%. The estimated 6-month PFS and OS rates for FL were 32.2% and 77.2%. Overall response rates in the CLL and FL cohorts were 70.4% and 36.4%, with the presence of high-risk genetics having no negative impact. No unexpected adverse events were observed. Most frequently reported adverse drug reactions (ADRs) were diarrhea, nausea, pneumonia, rash, and fatigue.
Conclusion: This real-world study shows that idelalisib is an effective therapy for CLL and FL, regardless of age and high-risk genetic features, consistent with results from previous clinical trials. Collected safety data and the pattern of ADRs reflect those from previous studies.
KW  - Chronic lymphocytic leukemia
KW  - Follicular lymphoma
KW  - Idelalisib
KW  - PI3K inhibitor
KW  - Real world study
KW  - Treatment management
Y1  - 2022
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/78554
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-785541
SN  - 2152-2650
VL  - 22
IS  - 8
SP  - e777
EP  - e787
PB  - Elsevier
CY  - Amsterdam
ER  -