Bartosz Pula1, Elzbieta Iskierka-Jazdzewska2, Monika Dlugosz-Danecka3, Agnieszka Szymczyk4, Marek Hus4, Agnieszka Szeremet5, Joanna Drozd-Sokolowska6, Anna Waszczuk-Gajda6, Jan M Zaucha7, Jadwiga Holojda8, Weronika Piszczek9, Pawel Steckiewicz10, Malgorzata Wojciechowska11, Michal Osowiecki12, Wanda Knopinska-Posluszny13, Marek Dudzinski14, Daria Zawirska15, Edyta Subocz16, Janusz Halka16, Andrzej Pluta17, Ryszard Wichary18, Beata Kumiega19, Bozena K Budziszewska20, Wojciech Jurczak3, Ewa Lech-Maranda20,21, Krzysztof Giannopoulos22, Tadeusz Robak2, Krzysztof Jamroziak20. 1. Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland bartosz.pula@gmail.com. 2. Department of Hematology, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland. 3. Department of Clinical Oncology, Maria Sklodowska-Curie National Institute of Oncology, Krakow, Poland. 4. Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland. 5. Department of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland. 6. Department of Hematology, Oncology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland. 7. Department of Hematology and Transplantology, Medical University of Gdansk, Gdansk, Poland. 8. Department of Hematology, Specialist District Hospital, Legnica, Poland. 9. Department of Hematology, Copernicus Hospital, Torun, Poland. 10. Department of Hematology, Holycross Cancer Center, Kielce, Poland. 11. Department of Hematology, Specialist District Hospital, Olsztyn, Poland. 12. Department of Lymphoid Malignancies, Maria Sklodowska-Curie Memorial Institute and Oncology Centre, Warsaw, Poland. 13. Department of Hematology, Independent Public Health Care of the Ministry of the Internal Affairs with the Oncology Centre, Olsztyn, Poland. 14. Department of Hematology, Specialist District Hospital, Rzeszow, Poland. 15. Department of Hematology, Jagiellonian University, Krakow, Poland. 16. Department of Hematology, Military Institute of Medicine, Warsaw, Poland. 17. Department of Hematological Oncology, Regional Specialist Hospital, Brzozow, Poland. 18. Department of Hematology and Bone Marrow Transplantation, Katowice Medical Department, Silesian Medical University, Katowice, Poland. 19. Department of Hematology, Specialist District Hospital, Nowy Sacz, Poland. 20. Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland. 21. Department of Hematology and Transfusion Medicine, Centre of Postgraduate Medical Education, Warsaw, Poland. 22. Department of Experimental Hematooncology, Medical University of Lublin, Lublin, Poland.
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. Copyright
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. Copyright