ABSTRACT
Our unique case of Richter's Transformation presenting as leptomeningial infiltration in a CLL patient receiving venetoclax raises questions on whether the drug penetrates the blood-brain barrier and at what extend, especially in reduced doses given for drug-drug interactions.
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.
Subject(s)
Antineoplastic Agents/therapeutic use , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Protein Kinase Inhibitors/therapeutic use , Pyrazoles/therapeutic use , Pyrimidines/therapeutic use , Adenine/analogs & derivatives , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Comorbidity , Disease Progression , Drug Resistance, Neoplasm , Female , Follow-Up Studies , Humans , Leukemia, Lymphocytic, Chronic, B-Cell/diagnosis , Leukemia, Lymphocytic, Chronic, B-Cell/etiology , Leukemia, Lymphocytic, Chronic, B-Cell/mortality , Male , Piperidines , Prognosis , Protein Kinase Inhibitors/administration & dosage , Protein Kinase Inhibitors/adverse effects , Pyrazoles/administration & dosage , Pyrazoles/adverse effects , Pyrimidines/administration & dosage , Pyrimidines/adverse effects , Recurrence , Retreatment , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND/AIM: Hematological malignancies are frequently complicated by secondary immunodeficiency (SID). Immunoglobulin replacement with intravenous gamma globulins (IVIg) reduces infection incidence, antibiotics' need and hospitalization days in these patients. Facilitated subcutaneous immunoglobulin replacement (fSCIg) has been studied in primary immunodeficiency patients and is equally efficacious with several advantages (self-administration, same bioavailability, long infusion intervals, fewer adverse drug reactions). fSCIg has been less extensively studied in SID. We present our retrospective single-center data of fSCIg administration to hematological patients with SID, focusing on efficacy and safety issues. PATIENTS AND METHODS: Overall, 33 hematological patients with hypogammaglobulinemia were treated with fSCIg according to ESMO 2015 guidelines, between mid-October 2015 and mid-January 2018 in our Department. RESULTS: The infection rate was very low (18.1%). Shorter infusion intervals further reduced it. ADRs were rare (9%) and mild (grade 1). fSCIg managed to reduce the everyday nursery/hospital burden of our tertiary hospital. CONCLUSION: fSCIg compares favorably to IVIg replacement in SID patients.