Safety and efficacy analysis of long-term follow up real-world data with ibrutinib monotherapy in 58 patients with CLL treated in a single-center in Greece. Issue 12 (15th October 2019)

• Record Type: Journal Article
• Authors: Dimou, Maria; Iliakis, Theodoros; Pardalis, Vasileios; Bitsani, Catherin; Vassilakopoulos, Theodoros P.; Angelopoulou, Maria; Tsaftaridis, Panayiotis; Papaioannou, Paraskevi; Koudouna, Aspasia; Kalyva, Sotiria; Kyrtsonis, Marie-Christine; Panayiotidis, Panayiotis
• Is Part Of: Leukemia & lymphoma. Volume 60:Issue 12(2019)
• Page Start: 2939
• Page End: 2945
• Publication Date: 2019-10-15
• Subjects: Ibrutinib -- chronic lymphocytic leukemia -- real-world data -- adverse events -- hypogammaglobulinemia -- autoimmunity; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2019.1620944
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: Ibrutinib (IB) revealed high efficacy and safety profile in phase 2/3 chronic lymphocytic clinical trials. Emerging real-world-data shows similar response and survival, but higher discontinuation rates due to adverse events (AEs). We present retrospective real-world data from 58 chronic lymphocytic leukemia (CLL) patients (August 2014–January 2019) treated with IB monotherapy, according to standard instructions, in a Greek single-center, focusing on safety and efficacy. Eleven untreated first line (1st L) and 47 relapsed/refractory(R/R) CLL patients received IB for 6.6(0.7–46.8) and 16.3(0.4–53.7) months, respectively. Nine percent of 1stL and 10.6% of R/R patients discontinued IB due to AEs. Atrial fibrillation (AF) was the most common discontinuation AE cause (3.5% of patients). Thirteen patients (24.5%) discontinued due to disease progression: 6 Richter transformation (RT) cases, after 10.6 months (1–35.9) and 7 CLL-progression cases, after 30.3 months (5.4–43.4) of IB initiation. IB had minimal impact on immunoglobulin G (IgG)-levels, CLL-related autoimmunity, and second primary malignancies (SPM). Our real-world data show that CLL patients present similar to clinical trials' outcomes if treated homogenously according to standard guidelines, resulting in fewer unneeded discontinuations and shrinkage of treatment armamentarium.