open access

Vol 48, No 4 (2017)
Prace oryginalne / Original research articles
Published online: 2017-10-01
Submitted: 2017-09-11
Get Citation

Analysis of ibrutinib efficacy in a subgroup of chronic lymphocytic leukemia patients with 17p deletion: observational study of the Polish Adult Leukemia Group (PALG)

Bartosz Puła1, Elżbieta Iskierka-Jażdżewska2, Marek Hus3, Agnieszka Szymczyk3, Aleksandra Gołos1, Magdalena Piotrowska4, Daria Zawirska4, Jan Maciej Zaucha567, Paweł Steckiewicz8, Marcin Pasiarski8, Dominik Chraniuk9, Weronika Piszczek9, Michał Osowiecki10, Edyta Subocz11, Janusz Hałka11, Anna Waszczuk-Gajda12, Joanna Drozd-Sokołowska12, Wanda Knopińska-Posłuszny13, Marek Dudziński14, Jadwiga Hołojda15, Małgorzata Wojciechowska16, Waldemar Kulikowski13, Agnieszka Szeremet17, Beata Kumiega18, Andrzej Pluta18, Mirosław Markiewicz19, Krzysztof Giannopoulos20, Tadeusz Robak2, Krzysztof Warzocha1, Krzysztof Jamroziak1
DOI: 10.1016/j.achaem.2017.10.004
·
Acta Haematol Pol 2017;48(4):330-337.
Affiliations
  1. Klinika Hematologii, Instytut Hematologii i Transfuzjologii, Warszawa, Polska
  2. Klinika Hematologii, Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Uniwersytet Medyczny, Łódź, Polska
  3. Klinika Hematoonkologii i Transplantacji Szpiku, Uniwersytet Medyczny, Lublin, Polska
  4. Oddział Kliniczny Hematologii, Szpital Uniwersytecki, Kraków, Polska
  5. Gdyńskie Centrum Onkologii - Szpital Morski im. PCK, Gdynia, Polska
  6. Zakład Propedeutyki Onkologii, Uniwersytet Medyczny, Gdańsk, Polska
  7. Katedra i Klinika Hematologii i Transplantologii, Gdański Uniwersytet Medyczny, Gdańsk, Polska
  8. Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii, Kielce, Polska
  9. Oddział Hematologii, Specjalistyczny Szpital Miejski im. Mikołaja Kopernika, Toruń, Polska
  10. Klinika Nowotworów Układu Chłonnego, Centrum Onkologii – Instytut, Warszawa, Polska
  11. Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny, Warszawa, Polska
  12. Katedra i Klinika Hematologii, Onkologii i Chorób Wewnętrznych, Warszawski Uniwersytet Medyczny, Warszawa, Polska
  13. Oddział Kliniczny Hematologii, SP ZOZ MSWiA, Warmińsko-Mazurskie Centrum Onkologii, Olsztyn, Polska
  14. Klinika Hematologii, Wojewódzki Szpital Kliniczny nr 1, Rzeszów, Polska
  15. Oddział Hematologiczny, Wojewódzki Szpital Specjalistyczny, Legnica, Polska
  16. Oddział Hematologiczny, Wojewódzki Szpital Specjalistyczny, Olsztyn, Polska
  17. Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Uniwersytet Medyczny, Wrocław, Polska
  18. Oddział Onkologii Hematologicznej, Szpital Specjalistyczny, Podkarpackie Centrum Onkologii, Brzozów, Polska
  19. Katedra i Klinika Hematologii i Transplantacji Szpiku, Wydział Lekarski w Katowicach, Śląski Uniwersytet Medyczny, Katowice, Polska
  20. Zakład Hematoonkologii Doświadczalnej, Uniwersytet Medyczny, Lublin, Polska

open access

Vol 48, No 4 (2017)
Prace oryginalne / Original research articles
Published online: 2017-10-01
Submitted: 2017-09-11

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.

Get Citation

Keywords

BTK inhibitor; ibrutinib; chronic lymphocytic leukemia; 17p deletion

About this article
Title

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

Acta Haematologica Polonica

Issue

Vol 48, No 4 (2017)

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

Regulations

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

By "Via Medica sp. z o.o." sp.k., ul. Świętokrzyska 73, 80–180 Gdańsk, Poland
tel.:+48 58 320 94 94, fax:+48 58 320 94 60, e-mail: journals@viamedica.pl