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

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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)

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.

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.

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