Analiza skuteczności ibrutynibu w podgrupie chorych na przewlekłą białaczkę limfocytową z delecją 17p: badanie obserwacyjne Polskiej Grupy ds. Leczenia Białaczek u Dorosłych (PALG)
PBN-AR
Instytucja
Instytut Hematologii i Transfuzjologii
Informacje podstawowe
Główny język publikacji
polski
Czasopismo
Acta Haematologica Polonica (14pkt w roku publikacji)
ISSN
0001-5814
EISSN
Wydawca
ELSEVIER Sp. z.o.o.
DOI
Rok publikacji
2017
Numer zeszytu
4
Strony od-do
330-337
Numer tomu
48
Identyfikator DOI
Liczba arkuszy
Autorzy
Pozostali autorzy
+ 26
Autorzy przekładu
(liczba autorów przekładu: 0)
Streszczenia
Język
angielski
Treść
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.
Cechy publikacji
oryginalny artykuł naukowy
original article
Inne
System-identifier
PX-5a0d41acd5de60d919fdc77e
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