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@article{949466,
author = {Wierda, William G. and Kipps, Thomas J. and Dürig, Jan and Griskevicius, Laimonas and Stilgenbauer, Stephan and Mayer, Jiří and Smolej, Lukáš and Hess, Georg and Griniute, Rasa and HernandezandIlizaliturri, Francisco J. and Padmanabhan, Swaminathan and Gorczyca, Michael and Chang, ChaiandNi and Chan, Geoffrey and Gupta, Ira and Nielsen, Tina G. and Russell, Charlotte A.},
article_number = {24},
doi = {http://dx.doi.org/10.1182/blood-2010-12-323980},
keywords = {FLUDARABINE PLUS CYCLOPHOSPHAMIDE; INITIAL THERAPY; MONOCLONAL-ANTIBODIES; HUMAN CD20; RITUXIMAB; OFATUMUMAB; TRIAL; CHLORAMBUCIL; CALGB-9712; GUIDELINES},
language = {eng},
issn = {0006-4971},
journal = {Blood},
title = {Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia},
url = {http://bloodjournal.hematologylibrary.org/content/117/24/6450.full},
volume = {117},
year = {2011}
}
TY - JOUR
ID - 949466
AU - Wierda, William G. - Kipps, Thomas J. - Dürig, Jan - Griskevicius, Laimonas - Stilgenbauer, Stephan - Mayer, Jiří - Smolej, Lukáš - Hess, Georg - Griniute, Rasa - Hernandez-Ilizaliturri, Francisco J. - Padmanabhan, Swaminathan - Gorczyca, Michael - Chang, Chai-Ni - Chan, Geoffrey - Gupta, Ira - Nielsen, Tina G. - Russell, Charlotte A.
PY - 2011
TI - Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia
JF - Blood
VL - 117
IS - 24
SP - 6450-6458
EP - 6450-6458
SN - 00064971
KW - FLUDARABINE PLUS CYCLOPHOSPHAMIDE
KW - INITIAL THERAPY
KW - MONOCLONAL-ANTIBODIES
KW - HUMAN CD20
KW - RITUXIMAB
KW - OFATUMUMAB
KW - TRIAL
KW - CHLORAMBUCIL
KW - CALGB-9712
KW - GUIDELINES
UR - http://bloodjournal.hematologylibrary.org/content/117/24/6450.full
N2 - We conducted an international phase 2 trial to evaluate 2 dose levels of ofatumumab, a human CD20 mAb, combined with fludarabine and cyclophosphamide (O-FC) as frontline therapy for chronic lymphocytic leukemia (CLL). Patients with active CLL were randomized to ofatumumab 500 mg (n = 31) or 1000 mg (n = 30) day 1, with fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 days 2-4, course 1; days 1-3, courses 2-6; every 4 weeks for 6 courses. The first ofatumumab dose was 300 mg for both cohorts. The median age was 56 years; 13% of patients had a 17p deletion; 64% had B2-microglobulin > 3.5 mg/L. Based on the 1996 National Cancer Institute Working Group (NCI-WG) guidelines, the complete response (CR) rate as assessed by an independent review committee was 32% for the 500-mg and 50% for the 1000-mg cohort; the overall response (OR) rate was 77% and 73%, respectively. Based on univariable regression analyses, B2-microglobulin and the number of O-FC courses were significantly correlated with CR and OR rates and progression-free survival (PFS). The most frequent Common Terminology Criteria (CTC) grade 3-4 investigator-reported adverse events were neutropenia (48%), thrombocytopenia (15%), anemia (13%), and infection (8%). O-FC is active and safe in treatment-naive patients with CLL, including high-risk patients.
ER -
WIERDA, William G., Thomas J. KIPPS, Jan DÜRIG, Laimonas GRISKEVICIUS, Stephan STILGENBAUER, Jiří MAYER, Lukáš SMOLEJ, Georg HESS, Rasa GRINIUTE, Francisco J. HERNANDEZ-ILIZALITURRI, Swaminathan PADMANABHAN, Michael GORCZYCA, Chai-Ni CHANG, Geoffrey CHAN, Ira GUPTA, Tina G. NIELSEN a Charlotte A. RUSSELL. Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia. \textit{Blood}. 2011, roč.~117, č.~24, s.~6450-6458. ISSN~0006-4971. Dostupné z: https://dx.doi.org/10.1182/blood-2010-12-323980.
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