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Non-interventional study evaluating the response to treatment in patients with chronic lymphocytic leukaemia (CLL) depending on rituximab-chemotherapy regimen
Affiliations- Klinika Hematologii, Instytut Hematologii i Transfuzjologii w Warszawie, Kierownik: prof. dr hab. n. med. Krzysztof Warzocha, Warszawa, Polska
- Roche Polska, Dział Medyczny, Warszawa, Kierownik: Agnieszka Brzezińska, Warszawa, Polska
- Katedra i Klinika Chorób Wewnętrznych, Zawodowych, Nadciśnienia Tętniczego i Onkologii Klinicznej, Uniwersytet Medyczny we Wrocławiu, Kierownik: prof. dr hab. n. med. Grzegorz Mazur, Wrocław, Polska
- Klinika Hematologii, Szpital Uniwersytecki w Krakowie, Kierownik: prof. dr hab. n. med. Aleksander Skotnicki, Kraków, Polska
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Abstract
A multicenter, prospective, observational, non-interventional study evaluated the response to treatment in patients with chronic lymphocytic leukemia (CLL) depending on the rituximab-chemotherapy (R-chemo) regimen used in routine clinical practice in Poland. The primary endpoint was the overall response rate (ORR) regarding the R-chemo regimen. The secondary endpoints were complete remission (CR), partial remission (PR), progressive disease (PD) and stable disease (SD) rates. A total of 400 CLL patients were enrolled in 20 sites in Poland. Data were collected on-line using eCRF during 6-months rituximab treatment. There were 150 treatment-naive patients (37.5%) and 250 patients with recurrent disease (62.5%) enrolled to the study. The overall ORR in R-FC-treated patients was 87.28%, 78.57% for the R-COP regimen, and for other regimens – 51.72%. Complete remission was achieved in 141 patients (36.25%), including 16.40% in patients receiving first-line treatment and 11.76% in relapsed disease. Partial remission was achieved in 166 patients (42.67%), including 38.4% in patients on first-line treatment and 38.56% in patients treated for recurrence. Complete or partial responses were achieved in 78.92% in total. No new safety signals were detected in comparison to safety profile described in Summary of Product Characteristics.
Abstract
A multicenter, prospective, observational, non-interventional study evaluated the response to treatment in patients with chronic lymphocytic leukemia (CLL) depending on the rituximab-chemotherapy (R-chemo) regimen used in routine clinical practice in Poland. The primary endpoint was the overall response rate (ORR) regarding the R-chemo regimen. The secondary endpoints were complete remission (CR), partial remission (PR), progressive disease (PD) and stable disease (SD) rates. A total of 400 CLL patients were enrolled in 20 sites in Poland. Data were collected on-line using eCRF during 6-months rituximab treatment. There were 150 treatment-naive patients (37.5%) and 250 patients with recurrent disease (62.5%) enrolled to the study. The overall ORR in R-FC-treated patients was 87.28%, 78.57% for the R-COP regimen, and for other regimens – 51.72%. Complete remission was achieved in 141 patients (36.25%), including 16.40% in patients receiving first-line treatment and 11.76% in relapsed disease. Partial remission was achieved in 166 patients (42.67%), including 38.4% in patients on first-line treatment and 38.56% in patients treated for recurrence. Complete or partial responses were achieved in 78.92% in total. No new safety signals were detected in comparison to safety profile described in Summary of Product Characteristics.
Keywords
Rituximab; Chronic lymphocytic leukemia; FC regimen
About this articleTitle
Non-interventional study evaluating the response to treatment in patients with chronic lymphocytic leukaemia (CLL) depending on rituximab-chemotherapy regimen
Journal
Issue
Pages
357-363
Published online
2017-10-01
DOI
10.1016/j.achaem.2017.09.002
Bibliographic record
Acta Haematol Pol 2017;48(4):357-363.
Keywords
Rituximab
Chronic lymphocytic leukemia
FC regimen
Authors
Krzysztof Warzocha
Marta Fidecka
Grzegorz Mazur
Daria Zawirska
Magdalena Piotrowska