1. Use of Ibrutinib in 10 Patients with Treatment-Naïve or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in Real-World Clinical Practice -A Report from a Single Medical Institution
- Author
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Yasunobu, Sekiguchi, Hiroko, Iizuka, Haruko, Takizawa, Toru, Mitsumori, Shigeki, Tomita, Hiroshi, Izumi, Mitsuo, Okubo, Kazunori, Miyake, Toshiya, Osawa, Tomohiro, Sawada, Seiichirou, Yoshikawa, and Masaaki, Noguchi more...
- Subjects
Treatment Outcome ,Japan ,Piperidines ,Adenine ,Humans ,Pyrazoles ,Leukemia, Lymphocytic, Chronic, B-Cell ,Retrospective Studies - Abstract
In Japan, ibrutinib has been approved as both a front-line and later-line treatment for chronic leukemia/small lymphocytic lymphoma(CLL/SLL). However, little is known about the actual outcomes and adverse events(AEs)associated with the use of ibrutinib in Japanese patients.The outcomes and AEs of patients treated with ibrutinib in a real-world setting were investigated.A retrospective cohort study of all patients with CLL/SLL who were treated with ibrutinib at a single institution was conducted.In total, 10 patients, including 5 treatment-naïve patients(50%), were enrolled. The median follow-up period was 9.8 months(range, 0.2-21.6 months), and the estimated overall response rate (ORR: complete remission plus partial remission)was 60%. The median overall survival and progression-free survival outcomes were not reached. During the follow-up period, 4 patients(40%)had at least one AE and 1 patient(10%)had at least one grade≥3 AE. Ibrutinib was discontinued in 4 patients(40%)because of AEs in 2 patients(20%), the progression of CLL in 1 patient(10%), and financial reasons in 1 patient(10%). Richter's transformation did not occur in any of the cases.The ORR was lower(60%)than that observed in clinical trials. The frequency and severity of AEs were both relatively low, although the discontinuation rate was high(40%). Patient education and medication adherence were considered important. more...
- Published
- 2021