open access

Vol 48, No 4 (2017)
Prace oryginalne / Original research articles
Published online: 2017-10-01
Submitted: 2017-01-26
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Non-interventional study evaluating the response to treatment in patients with chronic lymphocytic leukaemia (CLL) depending on rituximab-chemotherapy regimen

Krzysztof Warzocha1, Marta Fidecka2, Grzegorz Mazur3, Daria Zawirska4, Magdalena Piotrowska4
DOI: 10.1016/j.achaem.2017.09.002
·
Acta Haematol Pol 2017;48(4):357-363.
Affiliations
  1. Klinika Hematologii, Instytut Hematologii i Transfuzjologii w Warszawie, Kierownik: prof. dr hab. n. med. Krzysztof Warzocha, Warszawa, Polska
  2. Roche Polska, Dział Medyczny, Warszawa, Kierownik: Agnieszka Brzezińska, Warszawa, Polska
  3. 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
  4. Klinika Hematologii, Szpital Uniwersytecki w Krakowie, Kierownik: prof. dr hab. n. med. Aleksander Skotnicki, Kraków, Polska

open access

Vol 48, No 4 (2017)
Prace oryginalne / Original research articles
Published online: 2017-10-01
Submitted: 2017-01-26

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.

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Keywords

Rituximab; Chronic lymphocytic leukemia; FC regimen

About this article
Title

Non-interventional study evaluating the response to treatment in patients with chronic lymphocytic leukaemia (CLL) depending on rituximab-chemotherapy regimen

Journal

Acta Haematologica Polonica

Issue

Vol 48, No 4 (2017)

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

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