1. Long-term Efficacy of Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia: Results of the Polish Adult Leukemia Study Group Observational Study
- Author
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Marek Dudziński, Monika Długosz-Danecka, Małgorzata Wojciechowska, Michal Osowiecki, Elżbieta Iskierka-Jażdżewska, Weronika Piszczek, Jan Maciej Zaucha, Agnieszka Szymczyk, Edyta Subocz, Joanna Drozd-Sokołowska, Anna Waszczuk-Gajda, Beata Kumiega, Krzysztof Giannopoulos, Ryszard Wichary, Marek Hus, Bartosz Pula, Wojciech Jurczak, Tadeusz Robak, Bożena Katarzyna Budziszewska, Janusz Hałka, Wanda Knopinska-Posluszny, Krzysztof Jamroziak, Agnieszka Szeremet, Andrzej Pluta, Daria Zawirska, Paweł Steckiewicz, Jadwiga Hołojda, and Ewa Lech-Marańda
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,17p deletion ,Antineoplastic Agents ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Piperidines ,Recurrence ,Patient age ,Internal medicine ,medicine ,Humans ,Protein Kinase Inhibitors ,Aged ,Aged, 80 and over ,business.industry ,Adenine ,General Medicine ,Middle Aged ,medicine.disease ,Leukemia, Lymphocytic, Chronic, B-Cell ,Survival Analysis ,Clinical trial ,Leukemia ,Pyrimidines ,Treatment Outcome ,Oncology ,Tolerability ,chemistry ,Drug Resistance, Neoplasm ,030220 oncology & carcinogenesis ,Ibrutinib ,Pyrazoles ,Female ,Observational study ,Poland ,Refractory Chronic Lymphocytic Leukemia ,business - Abstract
Background/aim To study the long-term clinical efficacy and tolerability of ibrutinib monotherapy in real-world relapsed and refractory chronic lymphocytic leukemia (RR-CLL) patients outside clinical trials. Patients and methods Clinical data of 171 RR-CLL patients treated with ibrutinib were collected within the observational study of the Polish Adult Leukemia Study Group. Results Median patient age was 64 years. Patients were pretreated with 3 (1-10) median lines of therapy, while 42 (24.6%) had 17p deletion. The median observation time was 40 months (range=1-59 months), while median ibrutinib monotherapy reached 37.5 months (range=0.4-59.2 months). Response was noted in 132 (77.2%) patients. The estimated 5-year progression-free survival (PFS) and overall survival (OS) rates were 61.1% (95%CI=49.3-70.9%) and 56.8% (95%CI=45.6-66.6%), respectively. At the time of analysis 97 (56.7%) remained under ibrutinib monotherapy. Conclusion Ibrutinib is clinically effective and tolerable as a monotherapy in real-world RR-CLL patients.
- Published
- 2020