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Results of a prospective non-interventional post-authorization safety study of idelalisib in Germany
- 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.
Author: | Manuela HoechstetterORCiDGND, Wolfgang KnaufGND, Silvia DambacherGND, Nike HuckeGND, Kristin Höhne, Anna van Troostenburg, Heribert RamrothGND, Wolfgang Abenhardt, Mathias RummelGND |
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URN: | urn:nbn:de:hebis:30:3-785541 |
DOI: | https://doi.org/10.1016/j.clml.2022.04.007 |
ISSN: | 2152-2650 |
Parent Title (English): | Clinical Lymphoma Myeloma and Leukemia |
Publisher: | Elsevier |
Place of publication: | Amsterdam |
Document Type: | Article |
Language: | English |
Date of Publication (online): | 2022/07/15 |
Date of first Publication: | 2022/04/09 |
Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
Release Date: | 2023/10/20 |
Tag: | Chronic lymphocytic leukemia; Follicular lymphoma; Idelalisib; PI3K inhibitor; Real world study; Treatment management |
Volume: | 22 |
Issue: | 8 |
Page Number: | 11 |
First Page: | e777 |
Last Page: | e787 |
HeBIS-PPN: | 514479639 |
Institutes: | Medizin |
Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
Sammlungen: | Universitätspublikationen |
Licence (German): | Creative Commons - CC BY-NC-ND - Namensnennung - Nicht kommerziell - Keine Bearbeitungen 4.0 International |