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Analysis of ibrutinib efficacy in a subgroup of chronic lymphocytic leukemia patients with 17p deletion: observational study of the Polish Adult Leukemia Group (PALG)
Affiliations- Klinika Hematologii, Instytut Hematologii i Transfuzjologii, Warszawa, Polska
- Klinika Hematologii, Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Uniwersytet Medyczny, Łódź, Polska
- Klinika Hematoonkologii i Transplantacji Szpiku, Uniwersytet Medyczny, Lublin, Polska
- Oddział Kliniczny Hematologii, Szpital Uniwersytecki, Kraków, Polska
- Gdyńskie Centrum Onkologii - Szpital Morski im. PCK, Gdynia, Polska
- Zakład Propedeutyki Onkologii, Uniwersytet Medyczny, Gdańsk, Polska
- Katedra i Klinika Hematologii i Transplantologii, Gdański Uniwersytet Medyczny, Gdańsk, Polska
- Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii, Kielce, Polska
- Oddział Hematologii, Specjalistyczny Szpital Miejski im. Mikołaja Kopernika, Toruń, Polska
- Klinika Nowotworów Układu Chłonnego, Centrum Onkologii – Instytut, Warszawa, Polska
- Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny, Warszawa, Polska
- Katedra i Klinika Hematologii, Onkologii i Chorób Wewnętrznych, Warszawski Uniwersytet Medyczny, Warszawa, Polska
- Oddział Kliniczny Hematologii, SP ZOZ MSWiA, Warmińsko-Mazurskie Centrum Onkologii, Olsztyn, Polska
- Klinika Hematologii, Wojewódzki Szpital Kliniczny nr 1, Rzeszów, Polska
- Oddział Hematologiczny, Wojewódzki Szpital Specjalistyczny, Legnica, Polska
- Oddział Hematologiczny, Wojewódzki Szpital Specjalistyczny, Olsztyn, Polska
- Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Uniwersytet Medyczny, Wrocław, Polska
- Oddział Onkologii Hematologicznej, Szpital Specjalistyczny, Podkarpackie Centrum Onkologii, Brzozów, Polska
- Katedra i Klinika Hematologii i Transplantacji Szpiku, Wydział Lekarski w Katowicach, Śląski Uniwersytet Medyczny, Katowice, Polska
- Zakład Hematoonkologii Doświadczalnej, Uniwersytet Medyczny, Lublin, Polska
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Abstract
Background
The 17p deletion is regarded as the strongest poor prognostic factor in chronic lymphocytic leukemia (CLL). Results of recently performed clinical trials have suggested that ibrutinib significantly improves the outcome in this patient group.
Aim
The study aimed at analyzing the efficacy and adverse events profile of ibrutinib monotherapy in CLL patients with 17p deletion treated in routine clinical practice outside clinical trials.
Materials and Methods
Clinical response and adverse events profile of ibrutinib monotherapy were assessed in thirty-five CLL patients with 17p deletion treated within the ibrutinib named patients program in Poland.
Results
Overall response rate was 80% (28/35 patients) with median observation time of 24.2 months (range 0,1 – 30,9). Complete remission was observed in 5 patients (14.3%), partial remission in 11 (31.4%), partial remission with lymphocytosis in 13 (37.1%), whereas stable disease and progression was noted in 4 (11.4%) and 1 (2.9%) respectively. Response was not assessed in 1 patient. Median progression-free survival was 29.5 months, whereas median overall survival was not reached. Eleven patients died (7 because of infection, 1 of CLL progression, 1 of sudden cardiac death, 1 of disseminated breast cancer and 1 of unknown causes). In 13 patients (37.1%) at least one 3 or 4 grade adverse event occurred. In 11 patients (31.4%) the treatment was temporary withheld or the dose reduced due to adverse events.
Conclusion
Ibrutinib is characterized by high clinical efficacy and acceptable toxicity in CLL patients with 17p deletion in daily clinical practice.
Abstract
Background
The 17p deletion is regarded as the strongest poor prognostic factor in chronic lymphocytic leukemia (CLL). Results of recently performed clinical trials have suggested that ibrutinib significantly improves the outcome in this patient group.
Aim
The study aimed at analyzing the efficacy and adverse events profile of ibrutinib monotherapy in CLL patients with 17p deletion treated in routine clinical practice outside clinical trials.
Materials and Methods
Clinical response and adverse events profile of ibrutinib monotherapy were assessed in thirty-five CLL patients with 17p deletion treated within the ibrutinib named patients program in Poland.
Results
Overall response rate was 80% (28/35 patients) with median observation time of 24.2 months (range 0,1 – 30,9). Complete remission was observed in 5 patients (14.3%), partial remission in 11 (31.4%), partial remission with lymphocytosis in 13 (37.1%), whereas stable disease and progression was noted in 4 (11.4%) and 1 (2.9%) respectively. Response was not assessed in 1 patient. Median progression-free survival was 29.5 months, whereas median overall survival was not reached. Eleven patients died (7 because of infection, 1 of CLL progression, 1 of sudden cardiac death, 1 of disseminated breast cancer and 1 of unknown causes). In 13 patients (37.1%) at least one 3 or 4 grade adverse event occurred. In 11 patients (31.4%) the treatment was temporary withheld or the dose reduced due to adverse events.
Conclusion
Ibrutinib is characterized by high clinical efficacy and acceptable toxicity in CLL patients with 17p deletion in daily clinical practice.
Keywords
BTK inhibitor; ibrutinib; chronic lymphocytic leukemia; 17p deletion
About this articleTitle
Analysis of ibrutinib efficacy in a subgroup of chronic lymphocytic leukemia patients with 17p deletion: observational study of the Polish Adult Leukemia Group (PALG)
Journal
Issue
Pages
330-337
Published online
2017-10-01
DOI
10.1016/j.achaem.2017.10.004
Bibliographic record
Acta Haematol Pol 2017;48(4):330-337.
Keywords
BTK inhibitor
ibrutinib
chronic lymphocytic leukemia
17p deletion
Authors
Bartosz Puła
Elżbieta Iskierka-Jażdżewska
Marek Hus
Agnieszka Szymczyk
Aleksandra Gołos
Magdalena Piotrowska
Daria Zawirska
Jan Maciej Zaucha
Paweł Steckiewicz
Marcin Pasiarski
Dominik Chraniuk
Weronika Piszczek
Michał Osowiecki
Edyta Subocz
Janusz Hałka
Anna Waszczuk-Gajda
Joanna Drozd-Sokołowska
Wanda Knopińska-Posłuszny
Marek Dudziński
Jadwiga Hołojda
Małgorzata Wojciechowska
Waldemar Kulikowski
Agnieszka Szeremet
Beata Kumiega
Andrzej Pluta
Mirosław Markiewicz
Krzysztof Giannopoulos
Tadeusz Robak
Krzysztof Warzocha
Krzysztof Jamroziak